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A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-40.0, Depression Pregnant woman between 18 and 40 years of age Have depression as their only mental health disorder Have been receiving fluoxetine or citalopram for the treatment of depression for at least one month on the day of study entry for patients in the fluoxetine and citalopram arms, or no pharmacological treatment for patients in the control arm ≤ 26 weeks pregnant by estimated date of confinement Ability to give informed consent Singleton pregnancy Pregnant women no history of depression Having any comorbid mental disorder other than generalized anxiety disorder as a secondary disorder History of or current epilepsy, endocrine, cardiac, pulmonary, renal or hepatic dysfunction that could negatively influence pregnancy and/or neonatal outcome Abusing alcohol or drugs Use of any self prescribed herbal treatments for depression | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Major Depressive Disorder Age 18-65. 2. Written informed consent. 3. MDD, current according to the fourth version of the Diagnostic and Statistical Manual for Mental Disorders (DSM-IV) as diagnosed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998). 4. Quick Inventory of Depressive Symptomatology Self-Rated (QIDS-SR Trivedi et al, 2004) score of at least 10 at both screen and baseline visits Pregnant women. 2. Women of child bearing potential who are not using a medically accepted means of contraception (to oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or a partner with vasectomy). 3. Treatment with antidepressants for 2 weeks prior to the screen visit. If interested in discontinuing their current medication, potential participants must discuss this possibility with the prescribing physician. Study doctors will not implement any form of treatment washout. 4. Patients who no longer meet DSM-IV for MDD during the baseline visit, or patients who demonstrate a 25% or greater reduction in QIDS-SR scores, screening to baseline. 5. Serious suicide or homicide risk, as assessed by the evaluating clinician or a score of 4 on the third item of the HAM-D. 6. Unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease. 7. Patients who meet for alcohol or substance dependence, active within the last month. 8. Any bipolar disorder (current or past). 9. Any psychotic disorder (current or past). 10. Psychotic features in the current episode or a history of psychotic features. 11. History of a seizure disorder. 12. Clinical or laboratory evidence of untreated hypothyroidism. 13. Patients requiring excluded medications (see table 1 for details). 14. Prior course of ziprasidone, or intolerance to ziprasidone at any dose. 15. Any investigational psychotropic drug within the last 3 months. 16. Patients with significant cardiac conduction problems on screening electrocardiogram such as atrial fibrillation, atrial flutter, atrio-ventricular block, prolonged or abnormal QTc interval (i.e. QTc>450msec), or prolonged QRS interval. 17. Patients who have suffered a myocardial infarction within the past 12 months, with uncompensated heart failure, or a history of QTc prolongation. 18. Patients with abnormal serum potassium or magnesium levels upon screening. 19. Patients currently taking other drugs that prolong the QTc including dofetilide, sotalol, quinidine, class Ia antiarrhythmics, class III antiarrhythmics, mesoridazine, thioridazine, chlorpromazine, droperidol, pimozide, sparfloxacin, gatifloxacin, moxifloxacin, halofantrine, mefloquine, pentamidine, arsenic trioxide, levomethadyl acetate, dolasetron methylate, probucol or tacrolimus. 20. Patients who have failed to experience significant clinical improvement following 3 or more antidepressant trials of adequate duration (at least 6 weeks) and dose (minimal effective doses defined as: fluoxetine, paroxetine, citalopram 20mg; sertraline, fluvoxamine 50mg, escitalopram 10mg, paroxetine CR 25mg, venlafaxine 75mg, duloxetine 60mg, bupropion 150mg, 15mg of mirtazapine, trazodone or nefazodone 300mg) | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depressive Disorder, Major Major Depressive Disorder (MDD) Male and female subjects between the ages of 18 years with a psychiatric diagnosis of a MDE associated with MDD according to DSM-IV-TR (296.2/296.3) whose symptoms are considered mild to moderate and have not been taking antidepressant medication at the time of screening and for at least 4 weeks prior to randomisation If female, the subject is eligible to enter and participate in this study if she is not lactating and is of: 1. Non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal [defined as one year without menses for women >45 years of age]); is surgically sterile [via hysterectomy and/or removal of the ovaries] or, 2. Child-bearing potential, has a negative pregnancy test at both screen and baseline (prior to investigational product administration), and agrees to acceptable methods of contraception Body weight ≥ 50 kg and body mass index (BMI) between 18.5 0 kg/m2 inclusive Capable of giving informed consent and can comply with the study requirements and timetable Subjects have a HAM-D17 score > 18 and <25 at screening and baseline The subject must be able to read, comprehend and record information Non-smoker or light (< 10 cigarettes per day) smoker Agree to abstain from alcohol for 24 hours prior to the start of dosing until collection of the final pharmacokinetic sample Subjects whose symptoms of the MDE are better accounted for by another diagnosis As a result of any of the medical interview, physical examination or screening investigations the physician responsible considers the subject unfit for the study The subject has a history of a drug reaction or other allergy which in the opinion of the physician responsible contraindicates their participation in the study The subject is currently participating or has participated in a clinical trial with a new chemical entity or any investigational drug during the previous 2 months. In addition, the subject has not participated in clinical trials with more than 3 new chemical entities in the past 12 months The subject has a screening ECG with parameters outside ranges defined in the protocol The subject has a pulse rate <45 or >100 bpm and/or a systolic blood pressure >150 and/or <90 and/or a diastolic blood pressure >90 and <50 History of long QT syndrome (personal or family) or other cardiac conduction disorder, or other clinically significant cardiac disease The subject has any liver function test (LFT) elevated >1.5 times above the reference range at pre-study screening that remain elevated with a repeat LFT Any other clinically significant laboratory abnormality Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-80.0, Antidepressant Induced Sexual Dysfunction Subject is female, age 18 to 80 years Subject has been taking an SSRI, venlafaxine, or tri/heterocyclic antidepressant for the treatment of depression for at least 8 weeks; and is currently on a stable dose of the antidepressant for at least 4 weeks Subject is currently euthymic (HAM-D < 10) and is without significant anxiety symptoms (HAM-A < 10) Subject must have had no sexual dysfunction prior to taking antidepressant and there must be a clear temporal relationship between the sexual dysfunction and the antidepressant treatment Subject must have been consistently experiencing at least one of the following for at least 4 weeks, with distress or disability Inability to have an orgasm, according to patient opinion Clinically significant orgasm delay with masturbation or intercourse Inability to attain or maintain until completion of sexual activity an adequate lubrication swelling response of sexual excitement Decreased libido according to patient opinion Subject must be having or had been having some form of regular sexual activity (masturbation, oral sex, intercourse) at least twice monthly prior to the antidepressant treatment and are willing to continue efforts at sexual activity at least once weekly for the duration of the study Primary or prior diagnosis of a sexual disorder (other than the side effect of the bipolar medication or symptom of the bipolar disorder) Sexual dysfunction secondary to general underlying medical condition Penile, vaginal, clitoral or other sexual organ anatomical deformities Any uncontrolled psychiatric disorder Alcohol or substance abuse or dependence within the past six months Recent major relationship changes, disruption, or turmoil ongoing or anticipated which are unrelated to her sexual dysfunction Hamilton Depression and/or Anxiety Scale score (either) > 10 Blood pressure outside the range of 90/50 100 Known hyperprolactinemia | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-60.0, Depressive Disorder, Major Male or female = 18 years of age and < 60 years routine laboratory results within normal ranges Body Mass Index within the range 18.5-35.0 kg/m2 inclusive Subject must have had at least one previous major depressive episode with a diagnosis of MDD in his/her history, and had a successful pharmacological treatment of that episode, and is currently experiencing a recurrence of MDD presently un-medicated Subjects must met the diagnosis of an episode of Major Depressive Disorder in the past 12 weeks but not greater than 24 months The subject has any history of liver disease The subject has significant cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions that, in the opinion of the investigator and/or GSK medical monitor, places the subject at an unacceptable risk as a participant in this trial The subject has a history of autoimmune diseases The subject has any active infectious diseases, including active tuberculosis or a history of active tuberculosis The subject has a history of malignancy, except for surgically cured basal cell carcinoma or females with cured cervical carcinoma (> 2 yrs prior) The subject has a history of HIV or other immunosuppressive disease The subject has uncontrolled diabetes The subject is pregnant or nursing Subject has no contact with an adult on a daily basis (i.e., subjects who are not living with at least one other adult or subjects who do not have an adult who contacts them on a daily basis) Subject has initiated psychotherapy within three months prior to the Screening visit, or plans to initiate psychotherapy during the trial | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-82.0, Cancer of the Esophagus years of age or older Histologically or cytologically documented squamous cell carcinoma or Siewert's classification adenocarcinoma of the esophagus or proximal stomach T1-4, N0-2, M0-1, for which bimodality treatment with chemotherapy and radiation therapy is indicated Measurable Disease ECOG Performance Status 0-1 Laboratory values must be as follows Absolute neutrophil count > or = 2,000/mm3 Platelets > or = 100,000/mm3 Hemoglobin > 9.0 Total bilirubin <1.5 x institutional upper normal limit Serum creatinine <1.5 x institutional upper normal limit Tumors extending above the level of the thoracic inlet or beyond 5 cm below the gastroesophageal junction Patients with radiographic or bronchoscopic evidence of esophageal perforation Patients with known evidence of brain metastases, lymphangitic lung metastases, or carcinomatous meningitis Dementia or significantly altered mental status Major surgery within 4 weeks of the start of study treatment Prior chemotherapy, radiation therapy, hormonal or biologic therapy within the past 6 months Subjects requiring chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine, corticosteroids) Currently requiring medications that may interact with the metabolism or disposition of capecitabine/5-FU: dipyridamole, folinic acid, allopurinol, trimethoprim, misonidazole, metoclopramide, flucytosine or cimetidine Hypersensitivity to platinum containing compounds or capecitabine or any of the excipients of this product. Prior unanticipated severe reaction to fluoropyrimidine/platinum therapy, or known sensitivity to 5-fluorouracil/platinum containing compounds Serious, uncontrolled, concurrent infection(s) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-64.0, Bipolar Disorder Depression Normal or corrected-to-normal vision (tested by vision charts) Diagnosis of bipolar I disorder by the Mini International Neuropsychiatric Interview (MINI) HAM-D score of 17 or higher Meets for DSM-IV bipolar I disorder subtype rapid cycling Meets for DSM-IV mixed episode Pregnant Serious medical illness Neurologic disorder and/or head trauma Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder, including organic mental disorder, schizophrenia, delusional disorder, and psychotic disorders not otherwise specified Substance abuse or dependence within the 12 months prior to study entry and/or history of substance abuse for more than 12 months IQ of less than 80 on the Wechsler Adult Reading Test Previous treatment with CBT for depression Contraindications to MRI (e.g., metallic implants, claustrophobia) | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-50.0, Depression, Postpartum Primary DSM-IV diagnosis of major depressive disorder by clinical interview Score of greater than 12 on HAM-D Delivery of an infant within the 12 months prior to study entry Able to speak and read English sufficiently to complete the study procedures Willing to use effective birth control methods throughout the study Woman whose infant has died prior to study entry Current or past diagnosis of bipolar disorder, schizophrenia or other psychotic disorder Diagnosis of alcohol or drug abuse or dependence (except nicotine) or anorexia in the past year Psychotic symptoms Acute suicidal or homicidal risks Women who have been on an antidepressant for more than 14 days prior to consent, (if less than 14 days and willing to taper off, will be eligible to continue once tapered off) Women on daily anxiolytic medication (i.e. benzodiazepine, buspirone) or daily psychoactive herbal preparation (St. John's Wort or Fish Oil) (if willing to discontinue these substances may be eligible once they have been tapered off) Medications taken PRN over the listed dose and frequency (women will still be eligible if they take: Lunesta/Eszopiclone 3 mg or less, up to 3 nights a week, Ambien/Zolpidem 5mg or less, Ambien CR 6.25 mg or less, up to 3 nights a week, Lorazepam or equivalent benzodiazepine dose: 0.5 mg up to 3 nights a week, Sonata/Zaleplon: 5 mg or less, up to 3 nights a week, Rozerem/Ramelteon: 8 mg or less, up to 3 nights a week) If they take antidepressants PRN for insomnia (eg: Desyrel/Trazodone, Elavil/Amitriptyline, Remeron/Mirtazapine Ongoing concurrent psychotherapeutic treatment or psychotherapeutic treatment within the last month | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 20.0-65.0, Depressive Disorder, Major Patients who fulfil ICD-10´s for major depression, found within the ambulant psychiatric sector and who has a HAM-D ≥ 18 If the patient has pacemaker or other magnetic devices Pregnancy Has had an operation in the brain bipolar disorder | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Anxiety/Depression in Cardiological Unit investigated for chest pain or palpitation 6 month ago at Cardiological Out-patient Clinic, Molde Hospital suffer of chest pain or palpitations do not speak norwegian properly mentally retarded psychosis last 6 month current alcohol or drug misuse | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 43.0-60.0, Presbyopia age 43 to 60 years old outpatients wearing corrective lenses for presbyopia, referred to an optician within the last 6 months for a change in their optical correction associated hyperopia or astigmatism, the required correction had to be ≤ 3 dioptres in that case understanding, speaking French and able to answer a questionnaire first prescription of corrective lenses for presbyopia associated strabism associated amblyopia orthoptics therapy associated anisometropia > 1.5 dioptres patients treated for diabetes | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression DSM-IV diagnosis of major depressive disorder (MDD) Drug naive from prior psychotropic medication for more than 6 months before study entry Hamilton-Depression (HAM-D) 17 score greater than or equal to 16 Woman of childbearing age with a negative pregnancy test within 48 hours of scanning DSM-IV Axis I diagnosis other than MDD Use of psychotropic medication within 6 months of study entry History of bipolar disorder Current alcohol or drug abuse/dependence within 6 months of study entry History of sensitivity or intolerance to s-citalopram Medical contraindication to the use of s-citalopram Unstable medical condition (e.g., angina pectoris, untreated hypertension) Pregnant or nursing Woman of childbearing potential not using a medically acceptable form of birth control Actively suicidal or requiring hospitalization | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 35.0-90.0, Breast Neoplasms Ultrasonography be at least 35 years old, unless she has a strong pre-menstrual family history of breast cancer have had no screening mammogram in the past 10 months agree to have a screening mammogram that will not be reviewed until after a SonoCiné is performed agree to have a screening mammogram in approximately one year agree to answer follow up question in approximately one year meet the usual for breast screening (be asymptomatic of focal breast disease) have no history of breast cancer for at least one year agree to have both mammogram and SonoCiné if a physical finding or mammographic finding occurs within one year that requires biopsy greater than 7 cm compressed breast thickness at mammography | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, To Determine the Bioavailability of Tranylcypromine Subjects will be normal, healthy adult men and women who volunteer to participate Is the individual healthy, nonsmoking, normal adult man or woman who volunteers to participate? Is s/he at least 18 years of age? Is his/her BMI between 19 and 30, exclusive? Is she willing to avoid pregnancy by abstaining from sexual intercourse, or by the use of barrier methods. (diaphragm, condom, foams/jellies, sponge), and IUD, or has she has been surgically sterile or post menopausal at least six months prior to entering into the study? Is s/he considered reliable and capable of understanding his/her responsibility and role in the study? Has/s/he provided written informed consent? A no answer to any of the above questions indicates taht the individual is ineligible for enrollment Does the individual have a history of allergy or hypersensitivity to tranylcypromine? Does/ s/he have clinically significant laboratory abnormalities that would interface with the conduct or interpretation of the study or jeopardize his/her safety? Does s/he have significant history or clinical evidence of auto-immune, cardiovascular, gastrointestinal, hematopoietic, hepatic, neurological, ongoing infection, pancreatic, or renal diseases that would interface with the conduct or interpretation of the study or jeopardize his/her safety? Is she nursing? Does s/he have serious psychological illness? Does s/he have significant history ( within the past year) or clinical evidence of alcohol or drug abuse? Does s/he have a positive urine drug screen or saliva alcohol screen, or a positive HIV-1 , or hepatitis B or C screen, or a positive pregnancy test?-Is s/he unable to refrain from the use of alcohol or xanthine-containing foods or beverages during periods beginning 48 hours prior to study drug administration and ending when the alst blood sample has been taken? Is s/he unable to refrain from the ingestion of smoked meat, cheese (except cream cheese and cottage cheese), wine and beer during periods beginning 48 hours prior to study initiation and ending seven days after the last blood sample has been taken in study period two? Has s/he used any prescription drug during the 14-day period prior to study initiation, or any OTC drug during the 72-hour period preceding study initiation? Is s/he unable to refrain from the use of all concomitant medications during the study? | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression DSM-IV diagnosis of major depressive episode (MDE) or major depressive disorder (MDD) Drug free of psychotropic medication for more than 6 months before study entry item Hamilton Depression Scale (HAM-D17) score of greater than 16 Woman of childbearing age with a negative pregnancy test within 48 hours of study entry Absence of DSM-IV Axis I diagnosis as determined by Structured Clinical Interview for DSM Disorders (SCID) DSM-IV Axis I diagnosis other than MDE History of mania Current alcohol or drug abuse, or alcohol or drug dependence within 6 months before study entry History of sensitivity or intolerance to s-citalopram Medical contraindication to the use of s-citalopram Unstable medical condition (e.g., angina pectoris, untreated hypertension) Pregnant or breastfeeding Woman of childbearing potential not using a medically acceptable form of birth control Actively suicidal or requiring hospitalization Requiring additional psychotropic drug therapy | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-0.077, Premature Birth Mother and Father, if named on the birth certificate application, are English speaking If mother and Father are married, husband is the man identified as the father on the birth certificate application Documentation of Informed Consent for Mother and newborn. Father named on the birth certificate application must consent for newborn to participate Mother's age (and Father if named on the birth certificate application) is 18 years of age or older Infant is a singleton, inborn newborn Newborn gestational age assessment documented in the health record between 23 weeks 0/7 days and 36 weeks 6/7 days Newborn gestational age assessment documented in the health record > 37 weeks and 0/7 days Mother identifies herself as Black or African American on the birth certificate application Mother (or Father identified on the birth certificate application) refuses to sign informed consent Mother (or Father identified on the birth certificate application) does not speak English Father, identified on the birth certificate application, objects to infant's participation Husband is not the father named on the birth certificate application Mother (or Father, if named on the birth certificate application) is less than 18 years of age Mother fails to identify her ethnic group as Black or African American on the birth certificate application Mother is cognitively impaired as a result of receiving narcotic analgesia within four hours of the time the research is explained, consent explained, or the interview is conducted Mother is documented to be cognitively impaired by her physician in the medical record Father appears to be cognitively impaired at the time the research is explained, consent explained, or the interview is conducted Mother or infant has a history of blood transfusion in the last six months | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-60.0, Fibromyalgia Patient's between 18-60 yrs, belonging to either sex. With symptoms of chronic muscular pain of at least 12 weeks (that may or may not be consecutive) who fulfill the American College of Rheumatology (ACR) for the diagnosis of Fibromyalgia Patients of age group more than 60 yrs and below 18 years Pregnant or lactating females Patients with a history of trauma Patients with severe co morbid illness which prevents physical activity (for example, cardiovascular problems) Patients with the presence of specific medical disorders which require immediate treatment (for example, fractures, infectious diseases) Patients with associated neurological abnormality | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 17.0-999.0, Locally Advanced Nasal Cavity and Paranasal Sinus Squamous Cell Carcinoma Nasal Cavity and Paranasal Sinus Poorly Differentiated Carcinoma Sinonasal Undifferentiated Carcinoma Stage II Nasal Cavity and Paranasal Sinus Cancer AJCC v8 Stage III Nasal Cavity and Paranasal Sinus Cancer AJCC v8 Stage IVA Nasal Cavity and Paranasal Sinus Cancer AJCC v8 Stage IVB Nasal Cavity and Paranasal Sinus Cancer AJCC v8 Patients must have a confirmed (by a MD Anderson Cancer Center [MDACC] pathologist) cytologic or histological diagnosis of locally advanced squamous cell carcinoma, poorly differentiated carcinoma, or sinonasal undifferentiated carcinoma of the nasal cavity and/or paranasal sinuses Stage II-IV disease; tumor (T) 2-4, node (N) any, metastasis (M) 0. Measurable disease is required with the following Measurable lesions can be accurately measured, with at least one diameter >= 1.0 cm by spiral computed tomography (CT) scan or magnetic resonance imaging (MRI). Lesions can be bidimensionally measurable or unidimensionally measurable. Every effort should be made to measure lesions in two dimensions. Measurable disease is present if the patient has one or more measurable lesions. Non-measurable lesions/disease are all other lesions, including small lesions (those with measurements < 2.0 cm; or < 1.0 cm with spiral CT) Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-1 Absolute peripheral granulocyte count (AGC) of >= 1500 cells/mm^3 Platelet count of >= 100,000 cells/mm^3 Total bilirubin =< upper limit of normal (ULN). If the patient has a history of Gilbert's Syndrome, check direct and indirect bilirubin. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria Alkaline phosphatase =< 2 x ULN. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =< 2 x ULN. If in the judgment of the attending medical oncologist it is safe to treat the patient, the patient will be considered eligible for this criteria Hemoglobin >= 10.0g/dL Per MDACC creatinine clearance (CrCl) guidelines, patients must have a creatinine clearance > 50 ml/min determined by 24 hour collection or nomogram Evidence of distant metastases (below the clavicle) by clinical or radiographic measures Pre-existing peripheral neuropathy Common Terminology for Adverse Events (CTCAE) grade 2 or worse Pre-existing bilateral sensorineural hearing loss at > 90dB at any frequency from 250-8000Hz as assessed by a comprehensive audiometric evaluation for patients receiving cisplatin. This will not apply to patients receiving carboplatin Prior chemotherapy (i.e., as administered strictly for cancer treatment) within the previous 3 years. Use of chemotherapy agents for non-cancer treatment purposes (i.e., arthritis treatment, etc.) are excluded from this criterion Prior radiotherapy to the paranasal sinus region or the upper neck (i.e., prior radiotherapy to another disease site is acceptable) Initial surgical resection of the paranasal sinuses or nasal cavity region rendering the patient clinically and radiologically disease free Simultaneous primary invasive cancers or patients currently receiving any other investigational agents at time of study enrollment. Patients may have received investigational agents in the past. No washout time period is required Patients with a past history of malignancy that were treated less than 3 years and have not remained disease free for the past 3 years. (Patients with non metastatic skin cancers will be eligible) Men and women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the study. Subjects who are men must also agree to use effective contraception. Note: WOCBP must be using an adequate method of contraception throughout the study and for up to 3 months after the study. Adequate methods of contraception will (oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner) Women who are pregnant or breastfeeding | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 50.0-999.0, Severe Alzheimer's Disease Age range: Patients greater than 50 years. 2. Sex distribution: both men and women. Women must be two (2)-years post-menopausal or surgically sterile. 3. MMSE scores between 1 and 12 (inclusive). 4. Clinically significant behavioral pathology as measured by the Cornell Scale for Depression in Dementia(CSDD), defined as a total score on the CSDD of 5 or greater with at least one item rated 2 (severe) within the domains of Mood-Related Signs (Anxiety, Sadness, Lack of Reactivity, Irritability) or Behavioral Disturbances (Agitation, Retardation, Multiple Physical Complaints, Loss of Interest). 5. Diagnostic evidence of probable or possible Alzheimer's disease (DSM-IV and made or confirmed by the site physician at the time of the screening visit. This evidence must be fully documented in the patient's file prior to the baseline visit. 6. CT or MRI within the last 36 months consistent with a diagnosis of Alzheimer's disease without any other clinically significant comorbid pathologies found. A copy of the report will be required and should be appended to the case report form. If there has been a significant change in clinical status suggestive of stroke or other possible neurological disease with onset between the time of the last CT or MRI and the screening evaluation, the scan should be repeated if considered appropriate by the investigator. 7. Prior use of cholinesterase inhibitors (Aricept®, Exelon®, Cognex®, Reminyl/Razadyne®, metrifonate, physostigmine) and memantine is allowed, provided that the medication was discontinued at least 3 months prior to screening and that it was not discontinued for the purpose of enrolling the patient in the study. 8. Functional Assessment Staging (FAST) score >6a. 9. Patients residing in the community, assisted living facilities (ALF) or skilled nursing homes. 10. The patient must be expected to complete all procedures scheduled during the Screening and Baseline visits including all efficacy parameters. Patients must have a reliable caregiver or family member who agrees to accompany the patient to all clinic visits, provide information about the patient as required by the protocol, and ensure compliance with the medication schedule. For patients residing in assisted living facilities or skilled nursing homes, the reporting caregiver may be a professional staff member, provided he or she meets the in number 11, and study visits may take place in the facility if the study site staff finds this preferable to facilitate the smooth conduct of the study. 11. The caregiver must be a constant and reliable informant with a minimum of three days per week direct contact with the patient (for at least 4 hours per day during waking hours). This contact is necessary to ensure accurate reporting of the patient's behavior. 12. Patients with stable Type I (Insulin-Dependent) or Type II diabetes are eligible provided they are monitored regularly prior to and during the study to ensure adequate glucose control (hemoglobin A1c <8%). 13. Clinical laboratory values within normal limits and within the sponsor's guidelines, or abnormalities considered not clinically significant by the investigator and sponsor. 14. Patients with controlled hypertension (sitting diastolic BP < 95 mmHg and/or sitting systolic BP <160 mmHg), right bundle branch block (complete or partial), and pacemakers may be included in the study. 15. Patients with thyroid disease also may be included in the study provided they are euthyroid and stable on treatment for at least 3 months prior to screening. 16. Patients with a history of seizure disorder are allowed provided that they are on stable treatment for at least 3 months and have not had a seizure within the past 6 months. 17. Patients must be able to swallow tablet medication; no crushing of tablets is allowed. 18. Patients should be independent in ambulation or ambulatory-aided (i.e., walker, cane, or wheelchair); vision and hearing (eyeglasses and/or hearing aids permissible) should be sufficient for compliance with testing procedures. 19. Patients must be sufficiently proficient in the language in which the assessments are to be conducted Age range: Patients less than 50 years. 2. MMSE score of <1 or >12. 3. FAST score of < 6a. 4. CSDD>18 5. Patients with active or clinically significant conditions affecting absorption, distribution or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers or severe lactose intolerance). 6. Patients with a known hypersensitivity to piperidine derivatives or cholinesterase inhibitors. 7. Patients without a reliable caregiver, or patients or caregivers who are unwilling or unable to complete any of the outcome measures and fulfill the requirements of this study. 8. Patients with clinically significant obstructive pulmonary disease or asthma, untreated or not controlled by treatment within 3 months prior to screening. 9. Patient's with recent (< 2 years) hematologic/oncologic disorders (mild anemia allowed). 10. Evidence of active, clinically significant and unstable gastrointestinal, renal, hepatic, endocrine or cardiovascular system disease. 11. Patients with a current DSM-IV diagnosis of Major Depressive Disorder (MDD) or any current primary psychiatric diagnosis other than Alzheimer's disease (as per DSM-IV). Patients with CSDD scores >19 will be considered to have MDD and are excluded. 12. Patients with dementia complicated by other organic disease (DSM 290.30 or 290.11) are excluded; depressive symptoms and delusions are common in Alzheimer's disease, but patients with severe symptoms so pronounced that they warrant an alternative, concurrent diagnosis, are excluded. 13. Patients with vascular dementia or dementia complicated by tertiary syphilis 14. Patients with a known or suspected history of alcoholism or drug abuse (within the past 10 years). 15. Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-64.0, Depressive Disorder, Major Female outpatients aged 25-64 years, inclusive Subjects must have the ability to comprehend the consent form, and provide informed consent Subject currently meets the diagnosis for MDD (without psychotic features), single episode or recurrent, as defined in the DSM-IV-TR, diagnosed with SCID-CT (Structural Clinical Interview for DSM-IV Axis I disorders Clinical Trials Version) as assessed * by a physician with adequate training in psychiatry (e.g., Board Certification in psychiatry in the US or equivalent local qualification in other countries) Subject must, in the investigator's opinion based on clinical history, have met DSM IV-TR for their current major depressive episode for at least 4 weeks but for no greater than 24 months Subject has an IVRS HamD17 total score ≥ 23 at the Screening and Randomization Visits and the HAMD17 score is confirmed to be at least 20 by the Independent Efficacy Rater at the Screening and Randomization Visits The subject is eligible to enter and participate in this study if she is not lactating and Is of non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal [defined as one year without menses]); is surgically sterile [via hysterectomy and/or removal of the ovaries] or, is of child-bearing potential, has a negative pregnancy test at both screening and baseline (prior to investigational product administration), and agrees to acceptable methods of contraception Symptoms of the presenting illness which are better accounted for by another diagnosis*; or A current DSM-IV-TR Axis I diagnosis of Dementia; or Antisocial or Borderline Personality Disorder or other current DSM-IV-TR Axis II diagnosis that would suggest unresponsiveness to pharmacotherapy or non-compliance with the protocol; or A current (or within 12 months prior to the Screening visit) diagnosis of anorexia nervosa or bulimia; or A lifetime history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder Subject has an unstable medical disorder or a disorder that would interfere with the action, absorption, distribution, metabolism, or excretion of GSK561679 or may pose a safety concern, or interfere with the accurate assessment of safety or efficacy Subject has initiated psychotherapy within one month prior to the Screening visit, or plans to initiate psychotherapy during the trial. Subjects who present with their current MDD diagnosis despite longer-term psychotherapy (i.e., greater than three months prior to the Screening visit) and who agree to maintain the same therapy schedule during the trial may be included Subject has received vagus nerve stimulation, electroconvulsive therapy, or transcranial magnetic stimulation within the six months prior to the Screening visit Subject has previously failed adequate therapeutic courses of pharmacotherapy for MDD (e.g., maximum-labeled/tolerated doses for ≥ 4 weeks) from two different classes of antidepressants Subject, who, in the investigator's judgement, poses a homicidal or serious suicidal risk, has had any previous suicide attempt (including aborted, interrupted or ineffective attempts) or who has ever been homicidal | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Postoperative Nausea and Vomiting All of the following must be met for the potential subject to be eligible for participation: 1. The subject is a female scheduled to undergo ambulatory breast surgery performed under general anesthesia 2. The subject is expected to undergo general inhalation anesthesia. 3. The subject presents with two of the three following high-risk factors associated with PONV (must be in their medical history in order to be eligible) She is a non-smoker She has documented history of PONV and/or motion sickness She is expected to receive intra-operative and postoperative opioid. 4. The subject's American Society of Anesthesiologist physical status is ASA I-III 5. The subject is between18 to 65 years of age. 6. The subject is expected to be discharged from the hospital/surgical center on the same day as the surgery. 7. The subject has provided written informed consent to participate in the study. If any of the following are met, the potential subject is NOT eligible for participation: 1. The subject has a history of allergic reaction to, intolerances of or contraindications for any of the study medications or required anesthetic agents. 2. The subject has received or is expected to receive any excluded preoperative drug within 48 hours prior to induction; or is expected to receive any excluded intra-operative or postoperative medications. 3. The subject is pregnant or lactating. (If the potential subject is pre-menopausal, a urine pregnancy test must be performed within 24 hours/1 day of study prior to the planned surgery time and confirmed negative in order for the potential subject to be enrolled). 4. The subject is taking warfarin. 5. The subject has a history of alcohol and/or drug abuse within 1 year of study medication, or has a positive screening or pre-study test for alcohol or drugs of abuse. 6. The subject is expected to require the use of a nasogastric tube postoperatively. 7. The subject has a diagnosed latex allergy. 8. The subject has used oral aprepitant (Emend®) within the last 30 days. 9. The subject has participated in a randomized study or has been exposed to any experimental drug within 30 days prior to enrollment of this study | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Depression Subject age is 18 to 75 years old Subject meets the DSM-IV diagnosis of Major Depressive Disorder based on the MINI, with a current major depressive episode in partial remission Subject has been receiving treatment with an antidepressant medication for ≥ 3 months at a therapeutic dose. Therapeutic doses will be operationalized as those ranges noted by the drug manufacturers in their respective Package Inserts Subject's score on the 17-item Hamilton Depression Rating Scale (Ham-D) is > 8 despite treatment with antidepressant medication(s) Subject has subjective cognitive complaints Subject is mentally or legally incapacitated, unable to give informed consent Subject suffering from a cognitive, bipolar, or psychotic disorder on the on the basis of a MINI interview; in situations where there is ambiguity about the origin of cognitive symptoms (i.e. depression with cognitive symptoms VS early dementia) subjects will not be enrolled Subject meeting for an Axis II diagnosis that would interfere with completion of the protocol Known drug dependency or substance abuse within the past six months Subject has had a course of ECT, Transcranial Magnetic Stimulation (TMS), or Vagus Nerve Stimulation (VNS) within the six months prior to enrollment Unstable medical illness, any history of seizures, brain surgery, skull fracture, significant head trauma, or previous abnormal EEG Ham-D score > 25 despite pharmacotherapy Subject is a UCLA student or staff member directly under instruction or employment of any of the investigators Subject has a medical illness which might be exacerbated by tDCS treatments (e.g. skin abrasions or infection of the scalp might be exacerbated by the placement of the saline-moistened electrode pads) Subject is using any of the following medications which interfere with EEG measures of brain function: Anticholinergics, Barbiturates, Benzodiazepines, Sedating Antihistamines (e.g. diphenhydramine (Benadryl) would be exclusionary, but not loratadine (Claritin)) | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 16.0-65.0, Depressive Disorder, Major Bipolar Disorder Psychotic Disorders Between the ages of 16 and 65 2. Able and willing to provide informed consent 3. Able to read and speak English sufficiently to provide consent and answer questions 4. Diagnosis of one of the following Unipolar Major Depressive Disorder of any subtype Bipolar I, Bipolar II Disorder, or Bipolar Disorder NOS Axis I Psychotic Disorder, which can the diagnoses of Schizophrenia, Schizoaffective Disorder, Major Depression or Mania with Psychotic Features, Schizophreniform Disorder, Brief Psychotic Episode, or Psychotic Disorder NOS Normal volunteer controls, individuals with no personal history of any Axis I disorder Reported pregnancy or breastfeeding 2. Dementia or delirium 3. Any medical condition that would interfere with participation in the study. This would but not be limited to uncontrolled diabetes, hypothyroidism, Cushing's disease, or other significant endocrine condition (treated endocrine condition is allowed) demyelinating disease HIV infection active hepatitis CNS infection clinically significant and unstable cardiovascular disease any cancer involving the CNS (including metastatic disease) 4 for normal control subjects any history of mental illness or psychotropic drug abuse. 5. Participants will be excluded from the imaging portion of the study if they have any condition deemed to interfere with PET or MRI scanning, such as but not restricted to extreme obesity, metal fragments in eyes, metal implants in the head, or cochlear implant. These participants may still take part in the portion of the study involving the clinical assessment and providing biological samples | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 17.0-65.0, Major Depressive Disorder Major Depressive Disorder (DSM-IV) Hamilton Depression Rating Scale (17-item version) score 20 or greater Any psychotic disorder Substance abuse Organic brain disorder | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Major Depressive Disorder and out-patients with moderate to severe Major Depressive Disorder Major Depressive Episode (MDE) as primary diagnosis according to DSM-IV (classification code 296.xx) Moderate to severe depression Current MDE duration of at least 3 months Any current psychiatric disorder other than MDD as defined in the DSM-IV TR Any substance disorder within the previous 6 months Females of childbearing potential and not using adequate contraception Use of any psychoactive medication within 2 weeks before randomisation and during the study | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Urticaria Subjects must demonstrate their willingness to participate into the study and comply with its procedures by signing a written informed consent Subjects must be >=18 years of age, of either sex and any race Women of childbearing potential (includes women who are less than 1 year postmenopausal) must be using an acceptable method of birth control since at least one month prior to visit 1 (e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation). Women of childbearing potential should be counseled in the appropriate use of birth control while in this study Subjects must be in general good health as confirmed by medical history and, physical examination; i.e., they must be free of any clinically significant disease (other than chronic urticaria [CU]) that would interfere with study evaluations Subjects must understand and be able to adhere to the dosing and visit schedules, and agree to complete the questionnaires and to record accurately and consistently in a daily diary symptom severity scores, medication times, concomitant medications, and adverse events Subjects must have a history of CU defined as at least 6 weeks of pruritus and hives with hives lasting less than 24 hours and occurring at least 2 days per week Subjects must be experiencing a current CU flare with hives present at least 2 days in the week prior to the consent visit/visit 1 Subjects must have a pruritus score >=2 and a hive score >=1 at consent visit/Visit 1 or during the 12 hours before the consent visit/Visit 1 Subjects must score the Overall Condition of CU >=2 at both consent visit/Visit 1 and Visit 2 (Baseline) Subjects must have a total pruritus score of >=11 for the sum of morning (AM) and evening (PM) (reflective) diary scores for the 3 days prior to Visit 2 (Baseline) plus the morning score on the day of Visit 2 Women who are pregnant or nursing Subjects who have not observed the designated washout periods for any of the prohibited medications Subjects with asthma Subjects with drug or food allergies that manifest as skin reactions during 1 year prior to consent visit / visit 1 Subjects with atopic dermatitis Subjects with urticaria that is primarily due to physical urticaria or other known etiology (on the basis of clinical history and physical examination) Subjects with CU unresponsive to antihistamines Subjects under regular treatment with NSAIDs Subjects who have been hospitalized because of worsening in their CU within 3 months prior to Visit 1 (Screening) Subjects with a history of hypersensitivity to Desloratadine or any of its excipients | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 16.0-50.0, Bacterial Vaginosis Women will be included whether their complaint is symptoms of BV and have a positive whiff test/vaginal swab or if they have a positive whiff test/vaginal swab and are then asked if they have any symptoms of BV present. The following must be met for enrolment in the study: 1. ages 16-50 and premenopausal; 2. capable of giving written informed consent; 3. English speaking; 4. negative pregnancy test on enrolment day; 5. agree to follow study protocol; 6. documented BV infection by positive vaginal swab +/ positive whiff test/pH > 4.5; 7. agree to no intercourse for the 10 days of treatment (or to use non-lubricated condoms if unavoidable); 8. agree not to douche or use any intravaginal products during treatment (including tampons, medications, devices); 9. abstain from alcohol during the 10 days of treatment (from 24 hours before through 72 hours after taking study medication); 10. agree to no new medications or antibiotics during treatment; 11. no current sexually transmitted infection as determined by history, physical exam and negative swabs for chlamydia, gonorrhea, candidiasis, trichomonas; 12. patient is reliable for follow up The following women would be excluded from study participation: 1. less than 16 or post-menopausal; 2. negative vaginal swab regardless of whiff test/pH > 4.5; 3. menstruating at diagnosis; 4. symptoms so severe as to make allocation to placebo unacceptable to the patient; 5. currently pregnant or at high risk for pregnancy; 6. current sexually transmitted infection (HIV, hepatitis, chlamydia, gonorrhea, trichomonas, HPV or HSV); 7. current yeast infection as determined by history, physical and swabs; 8. history of PID; 9. allergy to latex or metronidazole; 10. presently lactating; 11. any open wound, excoriation, vaginal irritation and including bartholin's cyst/abscess as determined by physical exam; 12. presence of another vulvar, vaginal or medical condition, including cervical neoplasia treatment, that might confound treatment response; 13. using lithium, anti-coagulants or disulfiram drugs; 14. any antifungal or antibiotic use 14 days prior to enrolment 15. PAP smear done within one week of enrollment | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 25.0-999.0, Breast Cancer Female Asymptomatic Prior screening mammograms, if available, exhibit history of breast density Not currently pregnant or breastfeeding Not planning to become pregnant in the following 18 months Age 25 or older No breast surgeries or interventional procedures in the past 12 months No history of cancer diagnosis and/or treatment in the past 12 months Informed Consent and Completed Participant Questionnaire Complete screening mammography views (CC and MLO) for one or both breasts ≤ 50% preliminary parenchymal density on preliminary assessment by technologist Does not meet all for Enrollment | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Head And Neck Cancer Part 2. Patient is initiating radiation therapy for newly diagnosed head and neck cancer 2. Part 2. Patient has an Eastern Cooperative Oncology Group performance status score of 2 or less 3. Part 2. Patient has a spouse or significant other with whom he/she resides 4. Part 2. Patient is able to vocalize well enough to complete the spousal interaction task 5. Parts 1 and 2. Patient and spouse are able to read and speak English 6. Parts 1 and 2. Patient and spouse are able to provide informed consent 7. Parts 1 and 2. Patient and spouse are at least 18 years of age 8. Part 1. Individual is a patient who was diagnosed with head and neck cancer or the spouse or partner of an patient who was diagnosed with head and neck cancer and resides with the patient None | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Carcinoma, Non-Small-Cell Lung Pathologic or cytologic confirmed diagnosis of NSCLC 2. Recurrent, advanced or metastatic NSCLC that has progressed following one prior platinum based chemotherapy regimen (not counting adjuvant or neoadjuvant chemotherapy if completed more than 12 months prior to platinum based therapy) 3. Patients who are eligible for pemetrexed as second line chemotherapy 4. Measurable disease by one or more techniques (CT, MRI) according to 5. Patients aged 18 years or older 6. Life expectancy of at least three (3) months 7. Eastern Cooperative Oncology Group (ECOG) performance Score 0-2 8. Written informed consent that is consistent with ICH-GCP guidelines and local legislation Treatment with an investigational drug in another clinical study within the past 28 days prior to the start of therapy or concomitantly with this study 2. Anti-cancer therapy for NSCLC (except radiotherapy for palliative reasons) within the past 28 days prior to Treatment Day 1 of Cycle 1 of this trial 3. Any persisting toxicities which are deemed to be clinically significant from the previous therapy 4. Patients who have received more than one prior chemotherapy regimen for advanced disease (not including prior adjuvant therapy). Patients may have received prior epidermal growth factor receptor tyrosine kinase inhibitors. 5. Patients who are unwilling or unable to take folic acid and vitamin B12 supplementation 6. Active brain metastases (stable for <28 days, symptomatic, or requiring concurrent steroids). Patients who have received prior whole brain irradiation and whose brain metastases are stable according to the above will not be excluded. 7. Other active malignancy diagnosed within the past 3 years (other than non melanomatous skin cancer and cervical intraepithelial neoplasia) 8. Concomitant intercurrent illnesses including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or social situation that would limit compliance with trial requirement or which are considered relevant for the evaluation of the efficacy or safety of the trial drug 9. Patients unable or unwilling to interrupt concomitant administration of 5 days prior to, the day of and 2 days after the administration of pemetrexed, with the exception of lose dose aspirin 81mg daily 10. Patients who have received prior therapy with pemetrexed 11. Absolute neutrophil count (ANC) less than 1,500/mm3 12. Platelet count less than 100,000/mm3 13. Hemoglobin <90g/L 14. Total bilirubin >26µmol/L 15. Alanine amino transferase (ALT) and/or aspartate amino transferase (AST) less than 2.5 X ULN, except in case of known liver metastasis where maximum 5 X ULN is acceptable 16. Serum creatinine level >133µmol/L and/or creatinine clearance (measured or calculated) <45 ml/min 17. Clinically relevant QTc prolongation 18. Women and men who are sexually active and unwilling to use a medically acceptable method of contraception 19. Pregnancy or breast feeding 20. Known or suspected active alcohol or drug abuse 21. Patients unable to comply with the protocol 22. Any known hypersensitivity to the trial drugs or their excipients 23. Patients with NSCLC of confirmed Squamous histology | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Major Depressive Disorders patients suffering from a recurrent major depressive episode of at least moderate intensity (DSM-IV) patients have been hospitalized for the treatment of a previous episode, or a previous episode required antidepressant treatment(s)at the recommended dose level for at least 2 months the duration of the current episode is of at least six weeks unless the severity of symptoms justifies shorter duration | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-999.0, Colonic Neoplasms Colon cancer at any stage diagnosed histologically or high degree of suspicion for colon cancer at endoscopy, which cannot be confirmed with certainty in the biopsy. The diagnosis of cancer must be certain in the definitive histology Possibility of transabdominal injection of the dye (cancers below the peritoneal reflection in which the injection of dye must be carried out through rectoscopy, are therefore excluded) Patient's informed consent Prior intrabdominal tumor surgery Other preexisting malignancies Hypersensitivity/allergy to dye (isosulfan blue) Pregnancy Breast-feeding No patient's informed consent | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression Consent to participate in screening and study procedures by signing and dating the Informed Consent Form Are diagnosed with major depressive disorder (MDD) Have tried at least 4 different treatments, for example antidepressant medications, combinations of antidepressant medications, and/or electroconvulsive therapy (ECT) Screening MADRS score ≥ 28 Have had the current major depressive episode persist for at least 2 years Females, if of child-bearing potential, must be using an acceptable method of birth control Females: Currently pregnant Currently enrolled in or plan to enroll in any concurrent drug and/or device study that may confound the results of this study Have a neurological condition that may jeopardize the safety or the conduct of the study Have any medical conditions unsuitable for undergoing DBS surgery | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Diabetic Neuropathies Depressive Disorder, Major Present with pain due to bilateral peripheral neuropathy (according to International Statistical Classification of Diseases and Related Health Problems 10 (ICD 10). 2. To qualify for the MDD+ cohort, patients need to meet the ICD-10 for MDD. Furthermore, Hamilton rating scale for depression 17 (HAMD-17) scores need to match with the ICD-10 for qualification of the MDD+ or MDD groups. 3. Male or female outpatients at least 18 years of age. 4. Females with child bearing potential must test negative for a serum pregnancy test at Visit 1. Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post-menopause) must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study. Examples of reliable methods use of oral contraceptives or Depo-Clinovir Contraceptive Injection (sterile medroxyprogesterone acetate suspension, Pharmacia), partner with vasectomy, diaphragms with contraceptive jelly, cervical caps with contraceptive jelly, condoms with contraceptive foam, or intrauterine devices. Women who are pregnant or breast-feeding may not participate in the study. 5. Educational level and degree of understanding such that they can communicate intelligibly with the investigator and study coordinator. 6. Judged to be reliable and agrees to keep all appointments for clinic visits, tests, and procedures required by the protocol Have already a diagnosis of Depression and are currently treated with an antidepressant medication for depression, when entering the study. 2. Suffer from pain that cannot be clearly differentiated from or conditions that interfere with the assessment of DPNPain. 3. Had a historical exposure to drugs known to cause neuropathy, that could have been responsible for neuropathy. 4. Have previously been treated with duloxetine (for DPNP or MDD) 5. Are judged to be at suicidal risk by the clinical investigator or as defined by a score of 2 or greater on question 9 of the Beck Depression Inventory-II (BDI-II). 6. Had a history of substance abuse or dependence within the past year, excluding nicotine and caffeine | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 12.0-17.0, Depression Diagnosis of nonpsychotic major depressive disorder at least 4 weeks prior to study entry Clinical Global Impression-Severity (CGI-S) score of 4 or greater Children's Depression Rating Scale (CDRS) score of greater than 35 but less than 71 Currently attending school Willing and able to use acceptable methods of contraception, if applicable A signed letter from family physician verifying physical health necessary for participation in the exercise program Response to the Physical Activity Readiness Questionnaire (PAR-Q) indicates that no conditions are present that would render exercise inappropriate Speaks and reads English Parent or guardian willing to provide informed consent, if applicable Severe suicidal ideation History of psychotic disorders Alcohol or substance abuse or dependence within 6 months of study entry History of anorexia nervosa or bulimia Chronic medical illness requiring regular medication Pregnant Currently participating in a vigorous exercise program or activity, defined as 30 minutes of vigorous physical activity five times per week IQ less than 70 | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Colon Cancer Rectal Cancer Patients must be 18 years older Patients must be receiving his/her first dose of bevacizumab Patients must sign an informed consent Patients receiving > 10 mg/kg doses of bevacizumab | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 16.0-60.0, Anxiety Depression to 28 weeks pregnant and English speaking Non-English speaking | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depressive Disorders patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of > 18 on the Hamilton Depression Rating Scale (HAM-D) 17-items | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-999.0, Stress Healthy first-time mothers with singleton baby delivered at term with no complications Mothers with chronic health problems Pregnancy complications, OR Infants with congenital problems or conditions requiring admission to the intensive care nursery | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 20.0-999.0, Depressive Disorder <at the start of placebo run-in phase> Only the patients who meet all of the following conditions at Week -1 (at the start of placebo run-in phase) will be enrolled in this study. The hospitalization status will be no object. and Gender: No object Target disease: Patients diagnosed as having one of the following depressive disorders based on DSM-IV-TR classification in conjunction with M.I.N.I. (The Mini International Neuropsychiatric Interview, Japanese version 5.0.0. [2003]) and showing currently a symptom of depression or depressed sate Major depressive disorder, single episode (296.2) (excluding those accompanied by comorbid psychiatric disorders) Major depressive disorder, recurrent (296.3) (excluding those accompanied by comorbid psychiatric disorders) Age: >= 20 years (at the time of obtaining consent) Consent: Patients from whom written consent to participate in this study can be obtained Gender Female patients of childbearing potential can be enrolled. But, such patients who can be enrolled are limited to only those who are negative in the pregnancy test performed at the start of the placebo run-in phase and who agree to receive a pregnancy test at the time point defined in the study period and surely perform any of the contraceptive methods Male subjects must abstain from (or use a condom during) sexual intercourse with a pregnant or lactating female. Male subjects must abstain from or use a condom plus spermicidal agent (foam/gel/film/cream/suppository) during sexual intercourse with a female of child-bearing potential Patients whose HAM-D (17 items) total score is >= 20 points <at the start of placebo run-in phase> The patients who are meeting any of the following conditions at Week -1 (at the start of placebo run-in phase) must not be enrolled in this study Patients whose primary diagnosis is a disorder classified to Axis I other than major depressive disorder in DSM-IV-TR classification (dysthymic disorder, eating disorder, specific phobia (monophobia), posttraumatic stress disorder, obsessive-compulsive disorder, panic disorder, etc.) Patients with a current DSM-IV-TR Axis II diagnosis that suggested non-responsiveness to pharmacotherapy or non compliance with the protocol (e.g., antisocial or borderline personality disorder) Patients with a history or complication of another (non-MDD) mental disorder (schizophrenia, etc.) Patients with a history or complication of manic episodes Patients diagnosed as having an attentional deficit disorder or hyperactivity disorder Patients diagnosed as having a pervasive development disorder or mental retardation Patients diagnosed as abusing or dependent on alcohol or drug within one year before the Week -1 visit Patients who have undergone electroconvulsive therapy within one year before the Week -1 visit for the treatment of the current episode | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 14.0-18.0, Depression Family with an adolescent between 14 and 18 years of age and at least one parent or permanent guardian with whom the adolescent resides Family's primary concerns depressive symptoms Adolescent has a score above 24 on the Center for Epidemiological Studies-Depression Scale Family will be seeking services at the community mental health center that is associated with the study Adolescents presenting with evidence of severe difficulties associated with comorbid conditions, such that the focus of treatment would need to shift to nonaffective symptoms Adolescents evidencing symptoms of mania or psychoses or with suicidal behaviors requiring inpatient care Adolescents with cognitive limitations of severity that will preclude meaningful participation in the study | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depressive Disorder DSM-IV TR Diagnosis of Major Depression receiving medication management. Adequate trial of 2 or more antidepressants (ATHF) for a minimum of 6 weeks (one of which at UCSF). Hamilton Depression Rating Scale 17 score ≥ 14 Any Ethnicity English Speaking Male or Female No current psychotherapy (i.e. only medication management treatment) or plan to start new psychotherapy during MBCT or HEP Bipolar Disorder, Obsessive Compulsive Disorder, Schizophrenia, Schizoaffective Disorder, Antisocial and Borderline Personality Disorders, Current Eating Disorder, Pervasive Development Delay Major Depression with Psychotic Features Active Suicidality (per HAM-D17 > 1 on item 3) Meditation Practice once or more per week; yoga more than twice per week at study entry Substance Abuse Disorder within 6 months Cognitive Disorder with Mini Mental Status Exam score < 25 Medical illness rated 4 on Cumulative Illness Rating Scale | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-64.0, Depressive Disorder, Major Subjects must have the ability to comprehend the Informed Consent Form Male or female outpatients, aged 18-64, inclusive A primary diagnosis of major depressive disorder, single episode or recurrent Subjects must, in the investigator's opinion and based on the subject's history, have met depression for at least 8 weeks prior to the Screening Visit Subjects with symptom severity considered to be at least moderate to severe by the investigator Women of childbearing potential are only eligible IF they commit to consistent and correct use of an acceptable method of birth control that must be documentation at each visit Subjects whose mood-related symptoms are better accounted for by a diagnosis other than depression; subjects diagnosed with Alzheimer's Disease or other form of dementia; subjects diagnosed with a current/recent eating disorder such as anorexia nervosa or bulimia; subjects with a diagnosed history of schizophrenia, schizoaffective disorder, or Bipolar Disorder Subjects with any history of a significant abnormality of the neurological system (including dementia and other cognitive disorders or significant head injury) or any history of seizures (convulsions) Subjects have a positive urine test at screening for illegal drug use and/or who have a history of substance abuse or dependence (alcohol or drugs) within the past 12 months Subjects who are currently receiving regularly scheduled psychotherapy (individual or group), plan to start psychotherapy during the trial or have received regularly scheduled psychotherapy during the 12 week period prior to the Screening Visit Subjects who have a history of failing to respond to adequate treatment with an antidepressant, i..e, failure to improve following administration of at least two other antidepressants, each given for at least 4 weeks Subjects who, in the investigator's judgement, pose a homicidal or serious suicidal risk, have made a suicide attempt within the 6 months preceding screening or who have ever been homicidal Subjects who have received the following treatments for depression in the past: electroconvulsive therapy (ECT), vagal stimulation, or transcranial magnetic stimulation (TMS) within the 6 months prior to the Screening Visit Subjects with an unstable medical disorder; or with a disorder that otherwise would likely interfere with the activity of the study medication (orvepitant) Subjects have any screening laboratory abnormality that in the investigator's judgement is considered to be clinically significant Subjects with an abnormal thyroid test at the Screening Visit. Subjects maintained on thyroid medication must have normal thyroid levels for a period of at least six months prior to the Screening Visit | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 12.0-17.0, Major Depressive Disorder Dysthymic Disorder Depressive Disorder NOS Adjustment Disorder Ages 12-17 English speaking adolescent and parent One parent/primary caregiver willing to participate in adolescent's treatment Meets diagnostic for Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder NOS, or Adjustment Disorder with Depressed Mood BDI-II > 14 CDRS-R > 36 CGAS > 65 CBQ T score >65 Severe episode of Major Depressive Disorder (CDRS-R > 85 and/or PI clinical assessment) Current significant risk for suicide (active suicidal ideation with plan; active suicidal ideation without a plan if unable to contract for safety Meets diagnostic for substance abuse, schizophrenia, psychosis, bipolar disorder, conduct disorder, or eating disorder mental retardation medical illness likely to complicate or interfere with treatment currently in active treatment for depression currently taking medication for a psychiatric diagnosis other than ADHD or not on a stable dose of medication for ADHD (<3 months) Parent psychiatrically hospitalized within the past 3 months or parent psychopathology significantly severe to interfere with participation in their adolescent's treatment | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depressive Disorder Adult, outpatient with primary diagnosis of Major Depressive Disorder (depressive symptoms for at least 30 days prior to screening) Hamilton Psychiatric Rating Scale for Depression (HAM-D 17) total score of >= 20 Clinical Global Impressions Scale-Severity (CGI-S) score of >= 4 Significant risk of suicide as assessed by clinician judgment, HAM-D17 and Columbia Suicide-Severity Rating Scale scores Past treatment with desvenlafaxine succinate sustained release Other also apply | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Healthy Volunteer Fatigue Depression To be included, participants must meet the following Healthy, 18 years of age or older Speak and understand the English language Participants with any one of the following will be excluded Inability to provide informed consent for the study Are unwilling or unable to cooperate with the study procedures or travel to NIH for the procedures Have a confirmed medical condition causing clinically significant fatigue symptom (e.g. congestive heart failure, cancer actively receiving therapy, sleep disorders) Currently taking medications that cause fatigue (e.g. diuretics, beta blockers, narcotics) Working late evening and night shifts within the past month Have severe psychiatric conditions (e.g. major depressive disorder, bipolar disorder, anxiety disorder, schizophrenia, drug and/or addiction abuse or dependence) Report consuming more than 300mg of caffeine containing beverages (approximately 4 cups of coffee or 8 cups of soda or tea) or food (approximately 1 lb of chocolate) within 24 hours Reports consuming more than 2 servings of alcohol containing beverages every day and with detectable blood alcohol content (BAC) using breath analyzer (greater than 1 mg/dL of BAC) Pregnant or lactating women | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 21.0-999.0, Hyperlipidemia Men and women age > 21 LDL > 100 and physician suggestion to take statin Subject complains of muscle weakness or aching which he/she or his/her physician feels may be attributable to statin therapy Having stopped a statin drug for personal reasons and not willing to restart this medication Refusal to take a statin as prescribed by personal physician CPK < 400 Not taking any cholesterol lowering medication, red yeast rice extract or a phytosterol product for at least 1 month prior to initiation of trial Ability to exercise without physical restrictions Ability to attend 12 week consecutive Change of Heart lifestyle education sessions Liver function studies normal at baseline A history of muscle damage (CPK > 400 IU) on statin therapy Any active cardiac problem including chest pain, angina, shortness of breath with minimal activity, or unstable angina/acute coronary syndrome within one year Known intolerance to one of the study drugs Physical limitation preventing aerobic exercise program, such as severe arthritis, peripheral vascular disease, congestive heart failure, or symptom limiting pulmonary disease Uncontrolled hypertension (defined as SBP > 180 mmHg or DBP > 100 mmHg Heart attack, bypass surgery, or angioplasty/stent within 1 year of study Triglyceride level more than 400 mg/dl Underlying musculoskeletal disorder preventing muscle testing Taking other medicines including: cyclosporine, erythromycin or other macrolide antibiotics; fluconazole; niacin; fibrates; or > 16 oz. of grapefruit juice daily | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Atrial Fibrillation Deep Vein Thrombosis Dilated Cardiomyopathies Key The study population will all patients at the study sites who: 1. are in the maintenance phase of their warfarin treatment (defined using the standard method as the period of time following 2 consecutive visits, at least 7 days apart, of stable target INR after initiation of the drug) 2. whose providers indicate are expected to stay on treatment for at least 6 months 3. have a target INR of 2 to 3.5 4. had at least one INR out of the participant's target range within 90 days prior to enrollment (excluding the baseline visit) and/or INR at the baseline visit was below the participant's target range 5. have a working analog telephone line. Of note, patients do not have to be within their target INR range to enroll; we specifically want to those who are below the target range at the time of study entry because they may be the patients most likely to be non-adherent. Key Patients will be excluded if they do not meet the above 1. have an INR at screening above the target range 2. are less than 18 years of age and cannot or will not give consent 3. cannot read above a 6th grade reading level 4. are enrolled in a clinical trial of warfarin therapy 5. are unable to adequately follow study procedures | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-72.0, Depression Healthy participants should have no lifetime history of psychiatric disorder Depressed participants should have a current diagnosis of major depressive disorder, as defined by the DSM-IV History of bipolar affective disorder History of psychosis Current non-psychotic Axis I disorder, if it constitutes the predominant aspect of the clinical presentation and immediately requires treatment other than that offered in the study History of substance dependence within the past 6 months Antisocial, borderline, schizotypal, or schizoid personality disorders Evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments Current treatment with catecholaminergic antihypertensive medication, such as reserpine, beta-blockers, clonidine, and alphamethyldopa Current use of antidepressant medication Clear indication of secondary gain Current suicide risk sufficient to preclude treatment on an outpatient basis | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-45.0, Healthy Each woman enrolled in the trial must meet the following Competent to provide informed consent to participate in the trial and has done so At least the minimum age is 18 to 45 years old Had sex 1 to 4 days in past month and expects to continue at that frequency for the next 6.5 months At low risk for sexually transmitted infection (STI), operationally meaning that neither she nor her partner to her knowledge has had any of the following More than one sexual partner currently or any expectation of having more than one sexual partner in the next 6.5 months Diagnosis of human immunodeficiency virus (HIV) infection, hepatitis B or hepatitis C Treatment for a STI within the past 6 months, excluding recurrent genital herpes or condyloma Sharing of illicit injection drug equipment ever in the past Willing to use the study regimen as her only contraceptive method for the next 6.5 months (except that she may also use condoms if needed for protection from STIs) To be eligible for enrollment, a woman must not meet any of the following Pregnant as verified by a pregnancy test at enrollment Has an indication of current subfecundity, specifically Her last pregnancy ended within the last 8 weeks, or she has had fewer than two menstrual periods since resolution of last pregnancy She has not had normal monthly menses for the past 2 months She is currently breastfeeding She has used any hormonal contraceptive other than emergency contraceptive pills since the onset of her last menstrual period Has received an injection of a long term injectable contraceptive in the last 9 months Currently has an intrauterine device Has had a sterilization procedure or ectopic pregnancy | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 19.0-65.0, Depression Major depressive episode, diagnosed using the Mini-International Neuropsychiatric Interview (MINI) Depression not currently effectively treated Age 19 to 65 years Co-morbid Axis I disorders (co-morbid anxiety symptoms, including generalized anxiety or panic attacks, are not exclusionary if they are present in the context of a primary mood disorder) | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Major Depressive Disorder Clinical diagnosis of non-psychotic Major depressive disorder HAMD-17 score 14 or greater Age of 18 or greater and 65 or less patients with current or past history of diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder NOS patients with current psychotic features, eating disorders or obsessive-compulsive disorder patients with neurological disorder patients with medical condition that could interfere with everyday life activities pregnant or lactating women patients with current other DSM-IV TR Axis I diagnosis other than MDD which needs inpatient care patients who treated with ECT for current depressive episode insufficient information of past treatment for current depressive episode patients who posed a serious suicidal risk | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-55.0, Bipolar Depression Healthy male and/or female of non-childbearing potential between the ages of 18 and 55 years Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (>110 lbs) Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures Evidence or history of clinically significant medical condition or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of screening) Use of tobacco or nicotine-containing products within 3 months of screening or a positive urine or blood cotinine at screening A positive urine drug screen. History of regular alcohol consumption exceeding 7 drinks/week for females or 14 drinks/week for men | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depressive Disorder History of two or more Major Depressive Episodes or history of a Major Depressive Episode lasting at least one year Can speak, read, and understand English Meet for Current Major Depressive Episode or are in partial remission BDI-II score above 19 Abuse alcohol or drugs Current Dysthymic Disorder History of: psychosis when not depressed or intoxicated, Mania, Hypomania, Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, Anorexia Nervosa, Bulimia Nervosa | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 40.0-70.0, Menopause Women with menopausal Vasomotor symptoms (VMS) bothersome enough to warrant treatment; 2. Minimum of 7 hot flashes per day (on average); 3. Age limits: women ages 40-70 who have had at least one missed menstrual cycle or have undergone spontaneous menopause, women of any age who have medically induced menopause, women of any age who have had oophorectomy; 4. Informed written consent; 5. Ability to follow treatment protocols (cohort): 1. Concomitant illness with reasonable likelihood of limiting survival to less than one year; 2. Current substance abuse (alcohol or drug); 3. Pregnancy known, suspected or planned in next year; 4. Non-English speaking patients 5. Men (TA intervention): 1. Other concomitant menopause treatment; 2. Participating in acupuncture treatment or formal psychological stress management program within the last year; 3. Participating in another treatment for VMS, unless willing to stop it 4 weeks in advance of participation; 4. HIV infection, chronic or active hepatitis or other blood-borne illness | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Recurrent Head and Neck Carcinoma Recurrent Salivary Gland Carcinoma Recurrent Skin Carcinoma Skin Squamous Cell Carcinoma Patients with histologically confirmed cancer of the head and neck. Patients with salivary gland tumors and squamous cell carcinomas of the skin are also eligible. (Note: Any patient with a diagnosis of aggressive squamous cell carcinoma of the skin and determined to be surgically resectable will be considered for eligibility. These patients are typically seen in the Head & Neck surgery clinic and decisions for study consideration will be based on consultations with the department of Head & Neck surgery.) The patient must have biopsy-accessible disease Patients must be surgical candidates (either definitive or palliative setting) Patients may have received prior therapy including cytotoxic chemotherapy (e.g. platinum drugs and taxanes) and radiation therapy Patients must have a performance score (ECOG) of 0-2 Patients should have adequate bone marrow function, as defined by peripheral granulocyte count of >/= 1,000/mm³, and a platelet count of >/= 50,000/mm³.Patients must have adequate liver function with a bilirubin </= 1.5 times the upper limit of normal (ULN). Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must be </= 2 x the ULN and alkaline phosphatase must be </= 2 x ULN Patients should have adequate renal function (serum creatinine </= 1.5 x ULN) Age >/= 18 years Ability to understand and the willingness to sign a written informed consent document indicating that they are aware of the investigational nature of the study, in keeping with institutional policy Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Childbearing potential will be defined as women who have had menses within the past 12 months,who have not had tubal ligation or bilateral oophorectomy. Should a woman become pregnant or suspect that she is pregnant while participating in this study,she should inform her treating physician immediately.The patient,if a man,agrees to use effective contraception or abstinence Patients with prior exposure to small molecule tyrosine kinase inhibitors or EGFR-targeted antibodies within the past 6 months Patients for whom, in the opinion of the treating surgeon, the administration of erlotinib would cause a deleterious delay in surgical treatment Patients with uncompensated congestive cardiac failure Patients with an organ allograft Patients with a serious concurrent infection or illness including, but not limited to, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness that could limit compliance with study requirements Female patients who are pregnant or breastfeeding Patients currently on chemotherapy, immunotherapy, or therapy with monoclonal antibodies or other investigational agents with anti-tumor activity | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 19.0-60.0, Major Depressive Disorder (MDD) Male and female outpatients aged 19-60 years Patients will meet DSM-IV for major depressive disorder as determined by the mood disorders section of the Mini International Neuropsychiatric Interview (MINI, Sheehan et al, 1998) A score of 20 or greater on the Hamilton Depression Rating Scale (Ham-D), indicating at least moderately severe depression Competency to give informed consent Pregnant women, lactating women and sexually active women of childbearing potential who are not using medically accepted means of contraception Serious suicidal risks as judged by the clinician and the MINI The following DSM-IV diagnoses (to ensure a homogeneous diagnostic group): organic mental disorders; substance abuse/dependence, including alcohol, active within the last year; schizophrenia, paranoid, or delusional disorders; other psychotic disorders; panic disorder or generalized anxiety disorder, if a primary diagnosis; obsessive-compulsive disorder or post-traumatic stress disorder; bipolar disorder; bulimia nervosa or anorexia nervosa Serious illness including cardiac, hepatic, renal, respiratory, endocrinologic, neurologic and hematologic disease that is not stabilized, or a past history of convulsions Any retinal disease or systemic illness with active retinal involvement (e.g. diabetes) that precludes the use of bright light Patients who have a history of severe allergies and multiple drug adverse reactions Regular or current use of other psychotropic drugs, including lithium and tryptophan Patients treated with beta blocking drugs Hypertensive patients being treated with guanethidine, reserpine, clonidine or methyldopa (because of possible mood-altering effects of those drugs) Use of monoamine oxidase inhibitors within 14 days of Visit 1 (to ensure no drug interactions between fluoxetine and MAOIs), or use of heterocyclic antidepressants within 7 days of Visit 1 (to ensure adequate washout period of two weeks between stopping previous drug and start of treatment at Visit 2) | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Cancer Parents or primary guardians of children (ages 6 months through 17 years) with any malignancy whose child is 6-18 months post-diagnosis. 2. Ability to give informed consent. 3. English or Spanish speaking Severe psychological distress which in the judgment of the Principal or Associate Investigators at each respective collection site would compromise the participant s ability to understand the questionnaire or is likely to interfere with the study procedures or results. 2. Relapse of malignancy | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-60.0, Depressive Disorder, Major Key Adult subjects with primary diagnosis of moderate to severe MDD without psychotic features, for at least 4 weeks and one previous MDD episode Males or Females who agree to use protocol specified contraception if of child bearing potential BMI 18.5-35.0 kg/m2 Normal liver function tests Key History of liver disease or positive hepatitis B surface antigen or hepatitis C antibody in the last 3 months Elevated liver function tests on >2 ocassions in the last 7 months Significant medical illness, autoimmune disease or infectious disease Pregnant or nursing females Excessive and regular alcohol consumption History of substance abuse or dependence in past 6 months or positive urine drug screen Significant suicidal or homicidal risk Currently receiving chronic biological or pharmacologic anti-inflammatory therapy or is not euthyroid Psychoactive drugs within 1 week or 5 half lives of randomization visit Treatment resistant subjects | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-55.0, Major Depressive Disorder Depression Major Depression Aged 18-55 years Fulfilled the DSM-IV of major depressive disorder Had a 17-item Hamilton Rating Scale for Depression (HAMD-17)>or= 18 No DSM-IV diagnosis of substance abuse or dependence (including alcohol) within the past 6 months Had been drug free for > 3 months Physically healthy and had all laboratory parameters within normal limits Agree to participate in the study and provide informed consent Had history of epilepsy, head trauma or other major neurological or medical diseases Had psychotic depression, bipolar I/II disorder, schizophrenia or any other psychotic disorder Moderate-severe suicidal risks Severe cognitive impairment Female subjects who were pregnant, or at risk of pregnancy or lactation Initiating or stopping formal psychotherapy within six weeks prior to enrollment Had a history of poor response to SSRIs or previously received electroconvulsive therapy Had a history of severe adverse reaction to SSRIs | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Family Characteristics Health Status Family Research Male and Female Patients who receive primary care at one of the study selected Primary Care Practices are between 18-75 years old are English or Spanish speakers, and have appointments scheduled in the upcoming 1 months for an annual or comprehensive visit We will not individuals over the age of 75 because the role of family risk assessment and prevention is less established Also will not non-English or non-Spanish speakers Patients will also be excluded if they are hearing impaired | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Major Depressive Disorder Have received treatment with an SSRI (escitalopram, sertraline, paroxetine, or citalopram) for major depressive disorder Females of child-bearing potential to test negative for pregnancy at the time of enrollment based on a urine pregnancy test and agree to use a reliable method of birth control Apathy Evaluation Scale Clinician Rated Version (AES-C) total score >30 at screening and randomization Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤15 and Item 1 (apparent sadness) score of <2 at screening and randomization Have a level of understanding sufficient to provide informed consent and to communicate with the investigators, study coordinator, and site personnel Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device Have previously completed or withdrawn from this study or any other study investigating duloxetine Have had previous lack of response to an adequate trial of duloxetine within the past 12 months or escitalopram at any time Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), diagnosis of mania, bipolar disorder, treatment resistant depression or psychosis; or current suicide risk Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision(DSM-IV-TR),substance abuse or dependence within the 6 months Presence of an Axis II disorder Monoamine oxidase inhibitor (MAOI) treatment within 14 days prior to randomization or the potential need to use an MAOI during the study Positive urine drug screen for any substance of abuse or excluded medication Are pregnant or breast-feeding Serious medical illness, requires hospitalization during the study | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-70.0, Depressive Disorder Depressive symptoms of mild intensity, as defined in the International Classification of Mental Disorders (ICD 10), codes F32.0 (mild depressive episode) and F33.0 (recurrent depressive disorder, current episode mild) SDS Index between 51 and 59 (this criterion was declared null and void on 21.02.02 in the 2nd Amendment) HAM-D21 scores between 10 and 17 Between 18 and 70 years of age Duration of depression: not less than 4 weeks and not longer than 2 years Signed informed consent to take part in the clinical study after verbal and written information | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 60.0-999.0, Depression Age 60 years and older: This study focuses on the clinical complexities of late-life depression and its treatment. Family Services of Westchester (our partner community mental health agency) offers geriatric mental health counseling services to adults age 60 and older Diagnosis of unipolar major depression MADRS score >=18: Depression of such severity in primary care patients requires treatment CANE score >0: Reflects the presence of at least one unmet need in the domains of housing, self-care, safety, finances, benefits, legal matters, transportation, etc. and thus need for social services Capacity to provide written consent for both research assessment and depression care management: PCPs will be asked to clinically evaluate prospective participants' capacity to consent and document it in their medical record Working knowledge of English: Command in English sufficient for comprehending questionnaires of the study and/or for understanding the DCM therapists. English does not have to be the subject's first language Psychotic depression: This will be determined by the Structured Clinical Interview for DSM Disorders(SCID) assessment; presence of delusions and or hallucinations. This is a severe disorder typically referred for treatment to mental health specialists Active suicidal ideation: This will be determined by the SCID and MADRS assessments. Older patients at these levels of risk for self-harm typically are referred to mental health specialists Antisocial personality by Diagnostic and Statistical Manual of Mental Disorders (DSM)IV: This disorder will possibly interfere with adherence to research procedures and treatment Significant Cognitive Impairment (MMSE score <24) or clinical diagnosis of dementia by DSM-IV: These conditions may limit the patient's ability to participate in treatment and require social service interventions exceeding those available through the proposed depression care management models Current participation in specialist psychiatric care: Such patients will require the development of collaborative arrangements for depression care management which differ from those being tested in this study Acute or severe medical illness: i.e., delirium, metastatic cancer, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction during the three months prior to entry; or drugs often causing depression, e.g., steroids, reserpine, alpha-methyl-dopa, tamoxifen, vincristine | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Major Depressive Disorder Depression as diagnosed under DSM-IV Axis I Disorders Score greater than 7 but less then 35 on the 17-item Hamilton Depression (HAM-D) Scale at screening The patient has relative(s) to care for him/her Informed consent obtained from the patient or relative Scores greater than 2 on the "suicide" item of HAM-D, or history of suicide attempt(s) in the past 12 months Current suicidal or homicidal risk, as determined by the investigator Clinically significant liver disease (such as hepatitis, cirrhosis, etc); or clinically significant elevation of liver enzyme tests (two times the upper limit of normal History of seizure disorder (other than febrile) Patient who has had monoamine oxidase inhibitor , any selective serotonin reuptake inhibitor or any other antidepressant in last 15 days Any of the following DSM-IV diagnoses current (within past 3 months) schizophrenia, schizo-affective, or other psychotic disorder; bipolar disorder; current panic disorder or obsessive compulsive disorder; history of psychotic features of affective disorder (mood congruent or incongruent) Patient with history of untreated or unstable thyroid disorder Failed to respond to at least two adequate antidepressant trials (defined as 6 weeks or more treatment with either greater than or equal to 150 mg imipramine, or tricyclic equivalent), or greater than or equal to 60 mg of phenelzine, or MAOI equivalent, or greater than or equal to 100 mg of sertraline, or its SSRI equivalent Have had other investigational drugs within 30 days or other psychotropic medication within 21 days Known allergy or hypersensitivity to the study medications | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-50.0, Major Depression Treatment GROUP: 1. Age 18-50 2. DSM-IV for major depressive disorder (MDD) 3. Minimum Hamilton Rating Scale for Depression (HAMD) score > 18 4. Right handed 5. Capacity to give informed consent and follow study procedures 6. English speaking Cannot give informed consent 2. Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures 3. Does not speak English 4. Known primary neurological disorders 5. Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic) 6. MRI contraindications e.g. foreign metallic implants, pacemaker 7. Known allergy or hypersensitivity to sertraline 8. Active suicidality 9. Severe or unstable medical illness or conditions or drugs that may cause depression 10. Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, psychotic features of depression, current obsessive compulsive disorder (OCD) or panic disorder. In general, subjects with a history of other Axis I disorders prior to their depression will be excluded. 11. Current episode has failed to respond to adequate trials of two prior antidepressants for at least 6 weeks at therapeutic doses. 12. Treatment with sertraline for at least one month in past 3 months. 13. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics. 14. Current psychotherapy 15. Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers. GROUP: 1. Age 18-50 2. No history of MDD 3. HAMD score < 7 4. Right handed 5. Capacity to give informed consent and follow study procedures 6. English speaking Cannot give informed consent 2. Significant handicaps (e.g. visual or hearing loss, mental retardation) that would interfere with testing procedures 3. Does not speak English 4. Known primary neurological disorders 5. Any other factor that in the investigators judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from clinic) 6. MRI contraindications e.g. foreign metallic implants, pacemaker 7. Severe or unstable medical illness or conditions or drugs that may cause depression 8. Any of the following diagnosed by DSM-IV: alcohol or substance abuse disorder, schizophrenia or other psychotic disorder, bipolar disorder, major depression, OCD or panic disorder. 9. Current use of psychotropic prescription or nonprescription drugs or herbals (e.g. hypericum) except for limited use of certain hypnotics. 10. Treatment with psychotropic drugs or drugs that affect the CNS such as beta-blockers or mood stabilizers | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Metastatic Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Stress Disorders, Post-Traumatic and older Married or in a married like relationship One partner has served in Afghanistan or Iraq Separated | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-64.0, Major Depression Patients with a diagnosis of major depressive disorder, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM-IV-TR) (296.3) and confirmed by the semi-structured Mini International Neuropsychiatric Interview (MINI) Inpatient hospitalization at screening Symptoms of depression present for <30 days or >2 years Significant suicide risk Mild depression as measured by standard clinical research scales History of failure to respond to antidepressant treatment Other psychiatric conditions that could obscure the results of the study For women of child-bearing potential, the unwillingness to use highly effective means of birth control The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-59.0, Depression Mild or moderate symptoms and signs of depression for more than 3 months and less than 3 years of duration Signed informed consent Severe symptoms and signs of depression or Suicide proneness Pregnancy or breastfeeding Receiving other experimental drug Use of anti-depressive medication within 15 days | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression or older pregnant: 12-32 weeks gestation able to speak English telephone access major depressive disorder or dysthymia on Medicaid receiving health care in King County, Washington currently in psychotherapy currently receiving pharmacotherapy from a psychiatrist high suicide risk history of bipolar disorder history of schizophrenia substance use or dependence in previous 3 months currently in a relationship with severe interpersonal violence history of repetitive self-harm behavior | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Smoking Cessation Depression Male or female cigarette smokers, 18-75 years, motivated to stop smoking and considered suitable for a smoking cessation attempt Smoked an average of at least 10 cigarettes per day during past year and over past month, and exhaled carbon monoxide (CO) > 10 ppm at screening Current or past diagnosis of MDD without psychotic features, either single or recurrent, using DSM IV TR based on clinical assessment and confirmed by SCID and at least one of the following On stable antidepressant treatment for MDD (stable dose for at least 2 months) Major depressive episode, using DSM IV TR, in the past 2 years successfully treated Current or past diagnosis of dementia, schizophrenia, schizoaffective disorder, or other psychotic disorder, bipolar I disorder, bipolar II disorder Subjects with antisocial, schizotypal, or any other personality disorder severe enough to compromise the subject's ability to comply with the study requirements Current use of either bupropion or nortryptiline | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Myelodysplastic Syndromes age > ou = 18 years and < 75 years. 2. must understand and voluntarily sign an informed consent form. 3. patient considered ineligible for intensive chemotherapy due to age, cardiac contraindication to anthracyclines, comorbidities, previous failure of intensive chemotherapy, or patient willing to avoid intensive chemotherapy. 4. must be able to adhere to the study visit schedule and other protocol requirements. 5. prior thalidomide allowed. 6. documented diagnosis of MDS (according to FAB definition, ie. with marrow blasts up to 30%, or CMML with WBC < 13000/mm3 that meets IPSS for intermediate-2 or high-risk disease. 7. with an associated del 5q[31](the deleted chromosomal region must 5q[31]), with or without additional cytogenetic abnormalities. 8. female subjects of childbearing potential must understand the study drug is expected to have a teratogenic risk agree to have a medically supervised pregnancy test with a minimum sensitivity of 25mIU/ml on the day of the study visit or in the 3 days prior to the study visit once the subject has been on effective contraception for at least weeks. This requirement also applies to women of childbearing potential who practice complete and continued abstinence. the test should ensure the subject is not pregnant when she starts treatment agree to have a medically supervised pregnancy test every 4 weeks including 4 weeks after the end of study treatment, except in the case of confirmed tubal sterilization. these pregnancy tests should be performed on the day of the study visit or in the 3 days prior to the study visit. this requirement also applies to women of childbearing potential who practice complete and continued abstinence. * agree to use, and to be able to comply with effective contraception without interruption, 4 weeks before starting study drug throughout the entire duration study drug therapy(including doses interruptions)and for 3 months after the end of the study drug therapy even if she has amenorrhea this applies unless the subject commits to absolute and continuous abstinence confirmed on a monthly basis, to avoid pregnancy for the duration of study. the following are effective methods of contraception implant levonorgestrel-releasing intrauterine system(IUS) Medroxyprogesterone acetate depot, tubal sterilization sexual intercourse with a vasectomised male partner only(vasectomised must be confirmed by two negative semen analyses), ovulation inhibitory progesterone-only pills(i.e.desogestrel). if not established on effective contraception, the female subject must be referred to an appropriately trained health care professional for contraceptive advice in order that contraception can be initiated. Because of the increased risk of venous thromboembolism in patients with multiple myeloma taking lenalidomide and dexamethasone, combined oral contraceptive pills are not recommended. If a female subject is currently using combined oral contraception, the patient should switch to one of the effective methods listed above. The risk of venous thromboembolism continues for 4 to 6 weeks after discontinuing combined oral contraception. The efficacy of contraceptive steroids may be reduced during co-treatment with dexamethasone. Implants and levonorgestrel-releasing intrauterine systems are associated with an increased risk of infection at the time of insertion and irregular vaginal bleeding. Prophylactic antibiotics should be considered particularly in patients with neutropenia . Copper-releasing intrauterine devices are generally not recommended due to the potential risks of infection at the time of insertion and menstrual blood loss which may compromise patients with neutropenia or thrombocytopenia Understand that even if she has amenorrhea, she must follow all the advice on effective contraception She understands the potential consequences of pregnancy and the need to rapidly consult if there is a risk of pregnancy 9. Male patients must | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depressive Disorder PHQ-9 score ≥10 for Major Depressive Disorder (with 1 cardinal symptom) and/or ≥10 for Dysthymia (with 1 cardinal symptom) MINI confirmation of PHQ-9 diagnoses Access to a telephone English-speaking High suicide risk (PHQ-9 response) ≥2 prior suicide attempts Lifetime history of schizophrenia or bipolar disorder (MINI response) Substance abuse/dependence within the previous 3 months (CAGE-AID) Current severe intimate partner violence Currently seeing a psychiatrist | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 21.0-65.0, Obesity Age between 21 and 65 years Body mass index (BMI) between 25 and 45 kg/m2 Report a health condition on the Physical Activity Readiness Questionnaire (PAR-Q) Report being unable to walk for 2 blocks (1/4 mile) without stopping Report major psychiatric diseases/organic brain syndromes via a phone screen Are currently participating in a weight loss program and/or taking weight loss medication or lost > 5% of body weight during the past 6 months Intend to move to another city within the time frame of the investigation Are pregnant, lactating, less than 6 months post-partum, or plan to become pregnant during the time frame of the investigation Have had gastric surgery for weight loss | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Major Depressive Disorder Medically healthy males or females aged 18-65 (inclusive) Patients must have a primary current diagnosis of MDD without psychotic features Patients must be receiving ongoing antidepressant therapy at the time of screening. Duration of the current episode of MDD must be at least 8 weeks prior to enrollment without adequate response to treatment Patients with other psychiatric disorders Patients who use tobacco products Alcohol or substance abuse or dependence Treatment with a monoamine oxidase inhibitor within 10 weeks of enrollment Pregnancy or breastfeeding Clinically significant abnormalities on laboratory tests, electrocardiogram, or physical or neurologic examination | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Acute Coronary Syndrome Major Depressive Episode At least 18 years old Diagnostic and Statical Manual-Revision 4 (DSM-IV) diagnosis of current MDD based on the Structured Clinical Interview for Depression (SCID) Duration of major depressive disorder (MDD) at least 4 weeks at baseline Hospital discharge for an acute coronary syndrome 4 to 24 weeks prior to baseline No coronary artery bypass (CABG) surgery during or since the admission for the index event, and no plan for CABG during the next 4 months after baseline Stable coronary artery disease (CAD) based on physician's clinical judgement Provision of informed consent Significant cognitive problems (Mini-mental Status Exam, MMSE < 24) Structured Clinical Interview for Depression (SCID) documented bipolar disorder or use of lithium or anticonvulsants (e.g. tegretol, depakene, neurontin) for mood disorder MINI International Neuropsychiatric Interview (MINI) documented major depression with psychotic features MINI documented current or recent (within 12 months) substance abuse or dependence Serious suicide risk based on clinical judgment Currently taking antidepressants (including St. John's Wort) Absence of response to a previous adequate trial of citalopram Lifetime evidence of citalopram intolerance or lifetime evidence of intolerance to two or more other SSRIs or more previous unsuccessful trials of treatment for the current depressive episode Depression due to a general medical condition based on clinical judgment (e.g., clinical hypothyroidism) Cold, flu or other infection or dental work (including teeth cleaning) in 14 days before baseline | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 20.0-65.0, Depression Bipolar Disorder Mood Disorders Insulin Resistance Depressive Disorder, Major Depressive Disorder Criteria:1)Willingness to sign the Human Subject Protection Consent Form prior to enrollment into the study. 2)Men and women ages 20 to 65 years of age. 3)Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD) or depressive episode of bipolar disorder (Bipolar I, II or NOS), based on a Structured Clinical Interview for DSM-IV Axis I disorders (SCID) and confirmed by a psychiatrist. 4) Depression severity as defined by score of <17 on the 21-item Hamilton Rating Scale for Depression and no psychiatric admission within 6 months from study entry and no suicide attempt within the last 12 months. 5)Adequate visual and auditory acuity to allow neuropsychological testing. 6)Stable regime of psychiatric medications for 1 month prior to insulin test. Criteria:1)Diagnosis of possible or probable cognitive impairment. 2)For women only: pregnancy, breastfeeding. 3)Personal history of Type I or Type II diabetes. 4) Unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year. 5)Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressures > 100). 6) Current drug or alcohol abuse. 7)History of neurological disorder, e.g. multiple sclerosis, stroke etc. 8)Use of any drug that may significantly affect psychometric testing, or the insulin testing | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 5.0-12.0, ADHD Growth children meeting for any subtype of ADHD between the ages of 5-12 who are stimulant naive Children who meet any of the following will not be eligible to participate in this study children with a Full Scale Intelligence Quotient (I below 70 as children with IQs less than this would likely not benefit from the behavior therapy intervention not in full time school or less than 5 or older than 12 years at the time of the screening visit children who have a history of seizures or other neurological problems and are taking medication to prevent seizures as stimulants could worsen seizures children with a history of other medical problems for whom psychostimulant treatment may involve considerable risk including cardiac arrhythmias, hypertension, Tourette's Disorder or history of severe tic exacerbations secondary to stimulant exposure children with a history of other medical problems that could impact appetite or weight such as hypothyroidism, diabetes mellitus, liver or renal disease. Also, children using prescription medication that can significantly impact appetite or weight are excluded children with a childhood history or diagnosis of any of the following mental health disorders: pervasive developmental disorder, schizophrenia or other psychotic disorders, bipolar disorder, post traumatic stress disorder, major depression with serious suicidal thoughts or an eating disorder as stimulants are not safe and effective treatments for these conditions, and these diseases could affect eating habits children whose Body Mass Index is very low (too light for safe use of stimulant medication) or is too high (overweight so not suitable for weight promotion treatments) children allergic to milk proteins as they are in the caloric supplement (lactose intolerance okay) children previously treated with stimulant medications for more than 30 days as this study is focusing on children who have never used stimulant medication before | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression Meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Text Revised (DMS-IV-TR) for diagnosis of moderate or severe major depression without psychotic features Have a score >=40 on the subject-rated Inventory of Depressive Symptoms-Self-Report - 30-item (IDS-SR30) At Screening (Visit 1) and Randomization (Visit 2) Have a history of inadequate treatment response (as defined by failure to improve with a trial of adequate dosage and duration) with 2 antidepressants during the current episode, but no more than 4 antidepressant failures for lifetime Be in good general health prior to study participation with no clinically relevant abnormalities as assessed by the investigator and determined by: medical history, physical examination, blood chemistry, hematology, urinalysis, and electrocardiogram (ECG) Be within a body mass index (BMI) of >=18 and <35 kg/m2 at Screening (Visit 1) Have a DSM-IV diagnosis of current (active) generalized anxiety disorder, panic disorder, obsessive compulsive disorder, posttraumatic stress disorder, anorexia nervosa, or bulimia nervosa Have a history or current diagnosis of a psychotic disorder, bipolar disorder, mental retardation, or borderline personality disorders, mood disorder with postpartum onset, somatoform disorders, chronic fatigue syndrome or fibromyalgia Have a history of previous non-response to an adequate treatment with venlafaxine XR (defined as >=6 weeks of 75 to 150 mg/day or more) Have documented disease of the central nervous system that could interfere with the study assessments (including but not limited to: stroke, tumor, multiple sclerosis, Parkinson's disease, Alzheimer's disease, Huntington's disease, seizure disorder requiring current anticonvulsants, history of brain injury or trauma, or neurosyphilis) Have a history of alcohol or substance (except nicotine and caffeine) dependence or abuse according to DSM-IV in the past 12 months prior to Screening Received an experimental drug or used an experimental medical device within 60 days before the planned start of treatment (Day 1) or have participated in 2 or more clinical studies in the previous 1 year | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 40.0-70.0, Major Depressive Disorder Peri and postmenopausal women aged 40 to 70 years who are fluent in both written and spoken English Postmenopausal status defined by 12 consecutive months of spontaneous amenorrhea; less than 12 consecutive months with at least 6 consecutive months of spontaneous amenorrhea and a pre-baseline follicle-stimulating hormone (FSH) level >40 mIU/mL; or 6 months postsurgical bilateral oophorectomy (with or without hysterectomy). Perimenopausal women defined by the presence of any of the following within 6 months before baseline: 1. an absolute change of 7 days or more in menstrual cycle length within 6 months before baseline; 2. a change in menstrual flow amount (2 or more flow categories, eg, from light or moderately light to moderately heavy or heavy); 3. a change in duration (absolute change of 2 or more days); or 4. periods of amenorrhea lasting at least 3 months A primary diagnosis of major depressive disorder (MDD) based on the in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition-Text Revision (DSM-IV-TR), single or recurrent episode, without psychotic features using the modified Mini International Neuropsychiatric Interview (MINI) A Montgomery and Asberg Depression Rating Scale (MADRS) total score >=25 at the screening and baseline (day -1) visits and no more than a 5-point improvement from screening to baseline Treatment with DVS SR (Pristiq®) at any time in the past and/or venlafaxine, ie, Effexor® or Effexor XR®, 1 year prior to baseline Treatment-resistant; eg, in the past 3 years if any of the following treatments have failed: (a) 3 or more previous adequate trials of >=2 classes of antidepressant medication, (b) electroconvulsive therapy, or (c) 2 adequate trials of psychotherapy (eg, behavior therapy, behavior-marital therapy) History or current evidence of gastrointestinal disease known to interfere with the absorption or excretion of drugs or a history of surgery known to interfere with the absorption or excretion of drugs Known presence of raised intraocular pressure or history of narrow-angle glaucoma | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Normal (no Known Injury) Anal Sphincter Female Anatomy nulliparous women over the age of 18 any history of anal incontinence, chronic constipation, anorectal disease or trauma, neuromuscular or neuropsychiatric disease, diabetes, gastrointestinal disorders, or previous anorectal or pelvic surgeries | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-45.0, Healthy Subjects must fulfill all of the following to be considered for into this study Subjects who will provide written informed consent Subjects must be healthy, adult, human beings within 18-45 years of age (both inclusive)weighing at least 50 kg Having a Body Mass Index (BMI) between 18.5 and 24.9 (both inclusive), calculated as weight in Kg/height in m2 Subjects must be of normal health as determined by medical history and physical examination performed within 21 days prior to the commencement of the study Subjects whose screening laboratory values are within normal limits or considered by the physician/investigator to be of no clinical significance Availability of the subject for the entire study period and willingness to adhere to the protocol requirements as evidenced by written informed consent The subjects will be excluded based on the following during screening and during the study Subjects incapable of understanding the informed consent Subjects who have Systolic blood pressure less than 90 mm of Hg and more than 140 mm of Hg Diastolic blood pressure less than 60 mm of Hg and more than 94 mm of Hg. Minor deviations (2-4 mm of Hg) at check-in may be acceptable at the discretion of the physician/investigator Pulse rate below 50/min and above 100/min History of hypersensitivity or idiosyncratic reaction to Divalproex sodium or any other related drugs Any evidence of impairment of renal, hepatic, cardiac, lung or gastrointestinal function Consumption of grapefruit for the past ten days prior to the dosing day until the completion of the study Regular smoker who has a habit of smoking more than nine cigarettes per day and has difficulty in abstaining from smoking from 48 hours before dosing and during sampling period | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 11.0-18.0, Depression Age between 11 and 18; 2. one parent/legal guardian willing to participate in the study; 3. primary diagnosis of a depressive disorder (Major Depressive Disorder, Dysthymia, Depression NOS); 4. Short Mood and Feelings Questionnaire >11; 5. Children's Depression Rating Scale score > 45; 6. willingness to be randomized into either treatment group Adolescents will be excluded if they meet any of the following 1. primary diagnosis other than a depressive disorder; 2. presence of psychotic and/or manic symptoms; 3. presence of chronic medical condition; 4. presence of active substance abuse/dependence; 5. presence of chronic self-mutilation or cutting (e.g., persistent, severe, and/or requiring medical treatment); 6. presence acute or chronic suicidality (e.g., > 3 suicidal gestures in the past year), 7. previous unfavorable response to an adequate regimen of either CBT or antidepressant treatment in the prior year, and/or (8)developmental delay | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-64.0, Depressive Disorder, Major [At the start time of the run-in phase] Subject must have a primary diagnosis of major depressive disorder as classified by the DSM-IV-TR as below (however, to those accompanied by comorbid psychiatric disorders), and be showing currently a symptom of depression or depressive status: Major depressive disorder, single episode (296.2x); Major depressive disorder, recurrent (296.3x) Subject must have a total score of >=20 on the IVRS HAM-D (17 items) Subject must have a total score of >=25 on the IDS-SR Subject must have a score of >=1 on 4 out 5 items on the 5-item subscale of the IDS-SR (Item 19, 20, 21, 22 and 30), and a total score of >=7 on the 5-item subscale of the IDS-SR Subject must have a CGI-SI score of >=4 (i.e., Moderately ill or much worse) Subject must have the current depressive episode's duration of >=8 weeks but <24 months Subject is outpatient Subject must show QTc <450 millisecond (msec) or <480msec with Bundle Branch Block - values based on either single ECG values or triplicate ECG averaged QTc values obtained over a brief recording period Subject must show a value less than twice of the upper limit of normal value range of AST (GOT) and ALT (GPT), and a value <=1.5 times of the upper limit of normal value range of both Al-P and total bilirubin (however, subject who shows >35% of direct bilirubin with a value >=1.5 times of the upper limit of normal range of total bilirubin regards eligible) [At the start time of Run-in phase (Visit 1)] Subject has predispositions to seizure: who currently has or has a past history of seizure or seizure disorder, more than a single febrile seizure in infancy, cerebral tumour, or head / brain injury (traumatic); who has a family history of idiopathic seizure; who is diabetic patient with treating by oral hypoglycaemics or insulin; who uses drugs lowering the threshold of seizure Subject has a history or current diagnosis of anorexia nervosa (DSM-IV-TR 307.1) or bulimia (DSM-IV-TR 307.51) Subject has a primary DSM-IV diagnosis of, or received treatment for, panic disorder, obsessive compulsive disorder (OCD), posttraumatic stress disorder (PTSD), or acute stress disorder within 12 months before the start time of Run-in phase Subject has a DSM-IV diagnosis of schizophrenia, or other psychotic disorder(s) including bipolar disorder Subject has a history of or currently has manic episode(s) Subject has any other DSM-IV axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol (e.g., antisocial, borderline disorder or narcissistic personality disorder) Subject starting psychotherapy (except for supportive psychotherapy not aimed at therapeutic efficacy and unlikely to affect efficacy evaluation) or a cognitive behaviour therapy within 12 weeks before start time of the run-in phase Subject received electroconvulsive therapy (ECT) within 24 weeks before start time of the run-in phase Subject took MAO inhibitors (selegiline hydrochloride) within 2 weeks before start time of the run-in phase | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-75.0, Major Depressive Disorder The patient has recurrent MDD as the primary diagnosis according to DSM-IV-TR™ (classification code 296.3x) The patient has a MADRS total score >=26 The patient has a CGI-S score >=4 The patient has had the current episode of MDE for >3 months Any current anxiety psychiatric disorder as defined in the DSM-IV TR Current diagnosis or history of manic or hypomanic episode, schizophrenia or any other psychotic disorder, including major depression with psychotic features, mental retardation, organic mental disorders, or mental disorders due to a general medical condition as defined in the DSM-IV TR Current diagnosis or history of alcohol or other substance abuse or dependence (excluding nicotine or caffeine) as defined in the DSM-IV TR Use of any psychoactive medication 2 weeks prior to screening and during the study The patient is at significant risk of suicide or has a score >=5 on Item 10 (suicidal thoughts) of the MADRS, or has attempted suicide within 6 months prior to the Screening Visit Other protocol-defined and | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Human Papillomavirus Prevention Mother is greater than or equal to 18 years of age Mother has a daughter who is between the ages of 11-15 years Daughter has not received any doses of the HPV vaccine When asked to describe how she feels about getting her daughter vaccinated against HPV in the next six months, mother responds "I don't want her to get vaccinated" or "I'm unsure if I want her vaccinated." Cannot read/speak English | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Major Depressive Disorder The patient suffers from a primary diagnosis of MDD according to DSM-IV-TR (classification code 296.xx; current episode assessed using the MINI) The patient has a MADRS total score >=26 and a CGI-S score >=4 at the Baseline Visit Any current psychiatric disorder other than MDD as defined in the DSM-IV TR Female patients of childbearing potential who are not using effective contraception Use of any psychoactive medication 2 weeks prior to screening and during the study Other protocol-defined and | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Major Depressive Disorder Meeting diagnostic for major depression during the present episode of illness, currently with at least mild improvement by report (CGI-I ≥3) but with continuing residual symptoms. 2. A score of ≥10 on MADRS items 1,2,6,7 and 8, (the MADRS Dysphoric Apathy/Retardation factor, Parker et al., 2003) at screening and randomization. These 5 items are: Apparent sadness, Reported sadness, Concentration difficulties, Lassitude, and Inability to feel. A score of ≥3 will be required for at least 2 of these items. 3. A score of 3 or 4 on the Clinical Global Impression of Severity (CGI-S) at screening and randomization. 4. At randomization subjects must have received therapeutic dosages of approved SSRI or SNRI agents for at least 8 weeks, with the last 4 weeks at a constant dosage. 5. Females of Child-bearing Potential (FOCP) must have a negative serum beta Human Chorionic Gonadotropin (B-hCG) pregnancy test at the screening visit and a negative urine pregnancy test at the baseline visit, and agree to use one of the following methods of birth control: oral contraceptives, contraceptive implants, injectable contraceptives, IUDs, double-barrier contraception, sexual abstinence or vasectomized partner(s) Treatment within 4 weeks of randomization with any non-SSRI/SNRI antidepressant (trazodone is permitted up to 100 mg at night for sleep); any antipsychotic agent; any mood stabilizer; any standing benzodiazepine regimen other than at low doses for sleep (≤ 1 mg lorazepam HS or the equivalent); or a standing regimen of any other agent that may affect cognitive function (e.g., psychostimulants, including modafinil or R-modafinil). 2. Any current or past psychotic disorder, Bipolar I or II disorder, Current panic disorder, History of ADHD, Antisocial Personality Disorder or Borderline Personality Disorder, Mental retardation or any dementing disorder. 3. Covi Anxiety Scale score greater than Raskin Depression Scale score at Screening, to subjects with more prominent anxiety than depression 4. MADRS Sleep (item 4), or Appetite (item 5) >3 at screening or randomization 5. Initial insomnia at screening that is not adequately controlled by sleep medication (trazodone up to 100 mg HS for sleep and/or ≤ 1 mg lorazepam HS or the equivalent). 6. Medical conditions that might be exacerbated by Vyvanse treatment, such as uncontrolled hypertension or angina; or conditions that would make study findings hard to interpret, such as hyperthyroidism 7. History of seizure (other than infantile febrile seizures), any tic disorder, or a current diagnosis and/or family history of Tourette's Disorder. 8. Known cardiac structural abnormality or any other condition that may affect cardiac performance 9. Any clinically significant ECG or laboratory abnormality at Screening 10. Current abnormal thyroid function, as defined by abnormal TSH at Screening (Treatment with a stable dose of thyroid medication for at least 3 months is permitted if TSH is normal at screening). 11. Suicide attempt within the past 2 years or a history of any homicidal behavior. 12. MADRS Suicidal thoughts (item 10) >4 at any study visit, or if a patient is considered by the investigator to be at clinical risk of suicide at any time in the course of the study. 13. resting sitting systolic blood pressure >149mmHg or diastolic blood pressure > 95mmHg. Subjects may be on monotherapy with anti-hypertensive medication. 14. documented allergy, hypersensitivity, intolerance, or non-responsivity to methylphenidate or amphetamines. 15. Subject has a history of a substance use disorder (abuse or dependence, as defined by DSM-IV-TR™), with the exception of nicotine dependence, within 6 months prior to screening. 16. Subject has glaucoma 17. Subject is taking other medications that have central nervous system (CNS) effects or affect performance, such as sedating antihistamines and decongestant | 1 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Exercise Sedentary healthy, mobile, 18-65 year old employees who report they are engaging in less than 30 minutes of moderate intensity physical activity per week employees with significant auditory or visual problems and those who have severe musculoskeletal disorders that prevent them from engaging in physical activity. Medical clearance will be requested for those who report any cardiovascular disease | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-65.0, Depression Bipolar Disorder Age 18-70 years. 2. If female, nonpregnant/nonlactating 3. If a sexually active female of reproductive potential, must be using adequate contraception (i.e., oral contraceptives, barrier protection, or prior tubal ligation) 4. Currently meets DSM-IV for a major depressive episode, non-psychotic. 5. Having at least 3 of the following listed for predictors of depressive response to neuroleptics: a family history of bipolar disorder, antidepressant-induced mania, highly recurrent depressive episodes (>5), atypical depression, early age of onset of depression (< age 20), failure to respond to antidepressants, and antidepressant tolerance (initial response followed by later loss of response). Inadequate response to antidepressants is identified as follows: having a score of ≥14 on the 17-item HAMD or a CGI-S score of ≥ 3 after a retrospective confirmation of an adequate trial of a single antidepressant (defined as a ≥ 6-week trial of acceptable therapeutic dose [≥ 40 mg of fluoxetine, paroxetine or citalopram, 20 mg of escitalopram, 60 mg of duloxetine, 37.5 mg of paroxetine CR, 150 mg of sertraline, 100 mg of fluvoxamine, 225 mg of venlafaxine XR, 30 mg of mirtazapine, 300 mg of bupropion, 75 mg of nortriptyline, 20 mg of protriptyline, 100 mg of amitriptyline or imipramine) Bipolar depression 2. Sensitivity to or failure to respond to ziprasidone by history or ziprasidone use in previous 3 months 3. Active substance abuse or dependence in the previous 3 month 4. Psychotic disorders 5. Serious suicidality as evidenced by score of 3 or greater on suicide item of MADRS 6. Medically unstable as judged by study investigators 7. Lack of capacity to provide informed, written, consent to investigators 8. Previous diagnosed cardiac arrhythmias | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 5.0-84.0, Smoke Inhalation Injury Burns Child is at least 5 years of age and has not yet had his/her thirteenth birthday (for Studies # 1, 2, and 5) Subject (and child's caretaker for Studies #1, 2, and 5) speak English (2000 Census data indicate that less than 5% of the population older than five years of age in Franklin County, Ohio [where the study is located] speaks English less than "very well") Subject/family is able to be contacted by telephone (to obtain pre-study information and to remind the family about the study appointment and confirm that the child is in a normal state of health on day of study) For adult study arms: Study 3: Subjects are 20-49 years of age; Study 4: Subjects are 60-84 years of age Subject has a clinical diagnosis that may affect sleep, arousal or ability to perform the escape procedure Subject has a hearing impairment Subject is taking medication that may affect sleep, arousal, or ability to perform the escape procedure Subject has an acute illness at the time of the sleep study. The target population for Study 3 consists of adults 20-49 years of age, who have not yet had his/her fiftieth birthday. Adult participants must not have a clinical diagnosis that may affect sleep, arousal or ability to perform the simulated escape procedure. He/she must not have a hearing impairment; not be taking medication that may affect sleep, arousal, or ability to perform the escape procedure; and not have an acute illness at the time of the sleep study. The adult must speak English and be able to be contacted by telephone (to obtain pre-study information and to remind the participant about the study appointment and confirm that he/she is in a normal state of health on the day of the study). The target population for Study 4 consists of older adults 60-84 years of age, who have not yet had his/her eighty-fifth birthday. The older adult must not have a clinical diagnosis that may affect sleep, arousal or ability to perform the escape; not have a hearing impairment; and not be taking medication that may affect sleep, arousal, or ability to perform the simulated escape procedure. The older adult must not have an acute illness at the time of the sleep study. The older adult must speak English and be able to be contacted by telephone (to obtain pre-study information and to remind the participant about the study appointment and confirm that he/she is in a normal state of health on the day of the study). The target population for Study 5 is the same as that for Studies 1 and 2 | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Post-partum Depression Ethnic Hong Kong Chinese aged 18 years or above Within 6 months of giving birth Edinburgh Postnatal Depression Scale (EPDS) (Cox et al., 1987) score higher than or equal to 12 or being diagnosed as depressed by their obstetrician Meeting the Diagnostic and Statistical Manual of Mental Disorders-IV diagnosis for major depressive disorder item Hamilton Depression Rating Scale (HDRS17) (Hamilton, 1960) score of between 12 and 19 at screening and baseline assessment Willingness to give informed consent and comply with trial protocol Suffering from other psychiatric disorders such as schizophrenia, other psychotic disorders, bipolar disorder or substance use disorder Serious physical illnesses or mental disorders due to a general medical condition which are judged by the investigator to render unsafe A significant risk of suicide according to the rating of HDRS17 item 3 (score higher than 2), i.e., presence of ideas or gesture of suicide A presence of idea of self-harming according to the rating of EPDS item 10 (score higher than 0) A significant risk of infanticide according to the investigator assessment Any acupuncture treatment during the previous 12 months prior to baseline Valvular heart defects, bleeding disorders or taking anticoagulant drugs Infection or abscess close to the site of selected acupoints Herbal remedies or psychotropic drugs that are intended for depression are taken within the last 2 weeks prior to baseline or during the study Receiving counseling or psychological therapies at baseline or during the study | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 0.0-999.0, Depression h and 8th grade students at 4 participating middle schools Score 14 or above on the Mood and Feelings Questionnaire at screening (approximately top 25%) No imminent plans to move or change to non-participating school At minimum 6th grade language skills Agree to participate in random assignment and research interviews One Parent/caregiver willing to complete research interviews Student with past or current Major Depressive Disorder (MDD) or Probable MDD Students with parents who do not speak English or Spanish Students in concurrent treatment Students in self-contained classroom, or with cognitive delays, or emotional behavioral problems that would preclude them from benefiting from the group or being a good group member Parent not willing to complete research interviews | 0 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Depression Capable of giving informed consent Adults 18 years of age or older Members of either Asian American or Latino American minority groups Currently experiencing depressive symptoms Active unstable, untreated psychiatric illness precluding participation in study | 2 |
A 46-year-old Asian woman with MDD complains of persistent feelings of sadness and loss of interest in daily activities. She states that her mood is still depressed most of the days. She complains of loss of energy and feelings of worthlessness nearly every day. She is on anti-depressants for the past 6 months, but the symptoms are still present. She does not drink alcohol or smoke. She used to exercise every day for at least 30 min., but she doesn't have enough energy to do so for the past 3 weeks. She also has some digestive issues recently. She is married and has 4 children. She is menopausal. Her husband was diagnosed with colon cancer a year ago and is undergoing chemotherapy. Her past medical history is unremarkable. Her family history is negative for any psychologic problems. Her HAM-D score is 20. | eligible ages (years): 18.0-999.0, Bronchial Asthma fire smoke exposed patient > 18 years of age admitted to hospital < 18 years of ager trauma patient Control group (healthy volunteers/hospital staff) > 18 years of age non-smoker no exposure to fire smoke | 0 |
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