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A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Vaccination Hospitalization in one of the departments participating in the study At risk of pneumococcal infection according to HCSP recommendations (1) Negative pneumococcal vaccination status Adult patient (≥18 years old) Under safeguard of justice Unable to receive informed information Patient having objected to the use of their data | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, The Quality of Life of Parents of Children With Food Allergy Parents or caregivers who identify as having a child under the age of 18 with a food allergy The allergy has been diagnosed by a qualified physician (e.g. GP or allergy specialist) Mean score of >=2 on the FAQL-PB, indicating they are at least 'somewhat limited/troubled' by their child's allergy (Cohen et al., 2004) Resident in the United Kingdom Have access to email, a PC/laptop/tablet with a webcam and microphone and internet access to allow videoconferencing They had consulted on the design and content of the intervention or study They have already participated in a substantial mindfulness-based course They are currently engaged or are planning to engage with another psychological intervention during the course of the study They currently engage in regular mindfulness-based practice They do not have the practical means and time available to be able to attend the intervention during the dates outlined on the information sheet and commit to at-home practice They have scores >19 on PHQ-8 (indicating 'severe' depressive symptom severity; Kroenke et al., 2009) or >15 on GAD (indicating 'severe' level of anxiety; Spitzer et al., 2006) They have a problem with alcohol or recreational drug misuse They have experienced thoughts about harming themselves or others in the last 12 months They have been given a diagnosis of psychosis They are currently experiencing high levels of distress and/or currently feeling particularly fragile | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 25.0-55.0, Healthy age between 25-55 years less than two hours of physical training per week over the last two years before entering the study biking for transportation more than 40 km/week diagnosed with severe diseases medical treatment with a documented effect on body composition abuse of alcohol/drugs pregnancy or breastfeeding | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, COVID-19 Vaccines Priority groups for coronavirus (COVID-19) vaccination (health and social care workers) following breastfeeding practices and receiving vaccines cessation of breastfeeding and vaccine side-effects requiring specific treatment and/or hospitalization | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-90.0, Neurologic Manifestations stroke patients (hemorrhagic or ischemic) documented through Magnetic Resonance Imaging (MRI) or Computed Tomography (CT); 2. NeuroCOVID19 stroke patients with double nasopharyngeal swab negative after 24 hours for SARS-Cov2. 3. latency time within 6 months after stroke event; 4. sufficient cognitive and language skills to understand the instructions related to the administration of the assessment scales and to sign informed consent; - behavioral and cognitive disorders that may interfere with the therapeutic activity; 2. other orthopaedic or neurological complications that may interfere with the rehabilitation protocol; 3. inability to understand and sign informed consent; - | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 12.0-17.0, Food Allergy in Children Children and Adolescents ages 12-17 years with a food allergy To have reported anxiety or worry in relation to management of food allergy Able to attend the one-day workshop at the University of Surrey to complete the intervention in full (or online alternative) Willing and able to comprehend English and provide assent/consent Child does not speak English Able and willing to engage and understand the content of the workshop Currently under a mental health team and receiving ongoing psychological input Do not have the capacity to provide informed assent/consent and/or consent not gained from caregivers | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Peri-Implantitis subjects who were 18 years old or older at the time of intervention subjects who provided their informed consent for the intervention patients with total or partial edentulism treated with dental implants patients with at least 6 months follow-up, beginning from the date of placement of the prosthesis Incomplete data (e.g. absence of periapical radiographs) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Alcohol Drinking Pregnancy pregnant woman over 18 years old, presenting in one of the three maternities of the study for her prenatal care and having returned her self-report and having given her written consent woman under 18 years old or not pregnant or not having returned her self-report or woman who refused to participate in the study (absence of written consent) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.0-999.0, Same-day Surgery All participants/patients that will undergo a partial knee replacement (PKR) procedure within one consecutive year by one high-volume surgeon (i.e. no preselection of patients will be made) PKR procedures performed by other surgeons One-stage bilateral PKR procedures PKR procedures not given the first surgery slot of the day | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 40.0-55.0, Vasomotor Symptoms Hot Flashes Sleep Problem Being in the perimenopausal period according to the Staging of Reproductive Aging in Women (STRAW) Women in the early menopause transition phase (STRAW -2). In these women, there is a variation in the duration of the cycles for 7 days or more Women in the late menopausal transition phase (STRAW -1). These women have amenorrhea that lasts 60 days or longer Having entered natural menopause Not receiving hormone replacement therapy in the past and / or currently Not having a diagnosed psychiatric disease Not using alcohol Not using sleeping pills Not doing any other body-mind based practice (meditation, hypnosis, yoga, mindfulness techniques-minfulness, guided imagery technique), Not having a disease that may cause sleep problems and vasomotor symptoms and not receiving medical treatment (thyroid diseases, heart failure, neurological disorders) Women health initiative insomnia scale score above 10 Failure to communicate by calling 3 times on different days during the follow-up and the woman not returning to the phone call Woman not applying PMRE and health education at most 3 times a week The woman leaves the research voluntarily | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-90.0, Covid19 Influenza A Influenza B H1N1 Influenza Age 18-90 years Both genders Absence of infection by COVID-19, influenza H1N1, influenza A or B at the time of measurement of serum vitamin D levels Absence of infection at any site of bacterial, fungal or other origins Health worker at Hospital Clínica Nova. Patient for both arms Serum Vitamin D levels> 100ng / ml Previous consumption of supplements containing Vitamin D3 Pregnancy | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-99.0, Covid19 Endothelial Dysfunction Participants must be 18 years of age or older Participants must have a PCR confirming COVID 19 status Participants must be classified as critical as per the FDA evidence of critical illness, which is defined as respiratory failure requiring at least one of the following: Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen ≥ 0.5), noninvasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (i.e., clinical need for one of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation) Eligible for or already taking Statin Patients who are already on statins or Nicorandil Patients labeled as having mild, moderate or severe COVID-19 infection as per the FDA definitions Patients with shock as defined by SBP<90 for more than 30 minutes not responding to IV fluids with evidence of end organ damage Severe hepatic impairment (Child-Pugh class C) or active liver disease are absolute reasons not to be included especially those with unexplained persistent elevations of serum transaminases Pregnancy or breastfeeding Hypersensitivity to any of the above-mentioned medications On Levodopa Patients on PDE5 inhibitors, Riociguat Acute pulmonary edema Hypovolemia | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 10.0-999.0, COVID-19 Residence in one of the public housing complexes in Mott Haven, South Bronx English or Spanish-speaking Age 10 years or older Willing and able to provide informed consent or assent Non-resident of one of the public housing complexes in Mott Haven, South Bronx Neither English nor Spanish speaker Younger than 10 years old, unless household index case tests antigen positive. In this instance, all members of family will be included Unwilling or unable to provide informed consent or assent | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-75.0, Chronic Obstructive Pulmonary Disease Chronic Bronchitis Meet the diagnostic of acute exacerbation in chronic obstructive pulmonary disease or chronic bronchitis; 2. Meet the diagnostic of Phlegm-heat Syndrome (Tan-re Zheng) in TCM 3. Age from 18 to 75 years old, regardless of gender; 4. The score of each dimension of the sputum assement scale is ≥1; 5. Those who have not participated in other drug clinical research in the past one month; 6. Sign the informed consent letter Patients with pulmonary tuberculosis, bronchial cancer or other lung diseases. 2. Loose stools due to Spleen deficiency and stomachache caused by cold. 3. Diabetes or severe cardiovascular, liver (ALT>1.5×ULN), kidney (Cr>1.5×ULN) and other primary diseases. 4. Pregnant and lactating women. 5. Patients with acute and chronic respiratory failure. 6. Those who cannot give full informed consent due to mental disorders. 7. People with disabilities recognized by law. 8. People with allergies, or allergic to the ingredients of the drug used in this test. 9. Those who have used drugs with expectorant effects within the day. 10. Patients who are participating in clinical trials of other drugs. - | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 18.0-999.0, Covid19 Agree to participate in the trial by signing the IRB approved Informed Consent 2. Age ≥ 18 years of age 3. Positive diagnosis for COVID-19 by SARS-CoV-2 PCR by nasopharyngeal swab within the past 3 days 4. Two or more COVID-19 symptoms (at least one of which must be Respiratory) rated Mild or Moderate on the COVID-19 adapted FLU-PRO Plus scale 5. SpO2 ≥ 94 mm Hg 6. Ambulatory (not hospitalized) at the time of enrollment 7. At increased risk of developing more severe COVID-19 disease (at least one of the following): 1. Age ≥60 years 2. Presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, emphysema 3. Diabetes mellitus (type 1 or 2), requiring oral medication or insulin for treatment 4. Cardiovascular disease, including Hypertension, requiring at least 1 oral medication for treatment; congestive heart failure; coronary artery disease; cardiomyopathy; pulmonary hypertension 5. Body mass index ≥30 6. Chronic renal disease (but not on dialysis) 7. Sickle cell disease or trait 8. Comorbid disease (as above) well controlled/stable in opinion of the Investigator 9. Normal (or stable if abnormal per comorbidity) baseline ECG 10. Men of child-bearing potential must use birth control with heterosexual partner(s) (abstinence or condoms) 11. Women of child-bearing potential must meet all the following Use of birth control (abstinence, oral contraceptives, condoms, or intrauterine device) Test negative for β-subunit of HCG Pregnant or lactating 2. Treatment with COVID-19 antiviral such as remdesivir or SARS-CoV-2 antibodies 3. Prior COVID-19 vaccination or prior recovery from documented COVID-19 infection 4. Severe or Critical COVID-19, as indicated by respiratory distress or shortness of breath at rest; Resp Rate ≥30/min; Heart rate ≥125/min; SpO2 ≤ 93% on room air or PaO2/FiO2 ≤ 300 if on supplemental O2 5. Positive HIV or positive Hepatitis Panel 6. Treatment with any medications known to be strongly metabolized by CYP3A4 or CYP2D6 | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 0.75-15.0, Typhoid Fever In order to be eligible to participate in this study, an individual must meet the following Healthy participants aged 9 months to <16 years (i.e., ≤15 years and 364 days) of age at the time of vaccination Participants/Parents/legally authorized representative (LAR) who have voluntarily given informed assent (sought from participants aged 12 years to <16 years) and informed consent Participants/Parents/LAR living within study target area at the time of vaccination and willing to follow the study procedures and be available for the entire duration of the study An individual who meets any of the following will be excluded from participation in this study Known allergy to any vaccine component Self-reported ongoing acute and/or chronic illness Any self-reported coagulopathies Any medical or social compelling reasons in the judgment of a clinical physician Self-reported pregnancy/Positive urine pregnancy test or lactating Previous typhoid vaccination in the last 5 years (proven by the presentation of a vaccine card or self-reporting). Temporary Self-reported fever (elevated tympanic (≥38°C) or axillary temperature (≥37.5°C)) within 24 hours of vaccination Self-reported use of antipyretics within 4hours prior to vaccination Any other vaccination during the last 4 weeks (proven by the presentation of a vaccine card or self-reporting) | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 19.0-999.0, Healthy Adult Volunteers Those who are over 19 years old at the screening visit 2. Those with a body mass index (BMI) between 18.0 kg/m2 and 30.0 kg/m2 with a weight of 50 kg or more (45 kg or more for women) at the screening visit 3. Those who do not have clinically significant congenital or chronic diseases and have no pathological symptoms or findings upon medical examination at the screening visit 4. Those who determined as suitable study subjects by the principal investigator (or a delegated sub-investigator) in result of planned and conducted laboratory tests such as hematology, blood chemistry, serum, and urine tests according to the characteristics of the investigational product Those who have a clinically significant disease or have a history of such disease in the digestive system, cardiovascular system, endocrine system, respiratory system, blood/tumor, infectious diseases, kidney and genitourinary system, mental and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin system and ophthalmic system. 2) Those who have a history of gastrointestinal surgery (except for simple appendectomy or hernia surgery) that may affect the absorption of drugs or have gastrointestinal diseases 3) Those who have taken drugs that induce and inhibit metabolism enzymes such as barbital drugs within 1 month of the first administration date, or have taken drugs that may interfere with this clinical trial within 10 days of the first administration date. (However, participation is possible depending on the characteristics of pharmacokinetics and pharmacodynamics such as interactions with investigational products or half-life of concomitant drugs) 4) Those who participated in other clinical trials or bioequivalence studies and administered the investigational products within 6 months of the first administration date | 0 |
A 67-year-old healthy woman came to the clinic to have her flu shot in early October. She works at a rehab center and has no underlying disease. It is her first vaccination this year. she is menopausal and has 4 children. She does not some. She takes daily multivitamins and anti-hypertensive drugs. She exercises regularly for 30 minutes a day at least 5 days a week. She has no allergies to any food or drugs. | eligible ages (years): 12.0-999.0, Hereditary Angioedema (HAE) Participant is aged >= 12 years at the time of the last documented HAE attack in the period Participant has a physician-confirmed diagnosis (or confirmation in medical records) of HAE type I or type II Participant had initiated LTP with lanadelumab during the period Participant provides informed consent or assent prior to the initiation of any study procedures (where required by local regulations) Participant was enrolled in a therapeutic investigational drug or device trial during the observation period Participant without documented HAE attacks in the pre-index period and/or without available participant diary or systematic documentation of HAE attacks in the medical records during the post index 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): 18.0-65.0, Depression Patient must be ambulatory and relatively good health. Even if unable to work at least able to partially care care for self and not demented May have been alcoholic or drug abuser 6 months previous Unspecified CD4 Unspecified Non ambulatory patients or those requiring extensive help in self care are excluded Non ambulatory patients or those requiring extensive help in self care are excluded Current alcohol or drug abuse Unspecified | 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, HIV Infections Pregnancy A patient may be eligible for this study if she Is an HIV-positive woman Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available Had a baby on or after January 1, 1998 | 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, Mood Disorder The subjects of this study will be women who meet the following history within the last two years of at least six months with menstrually-related mood or behavioral disturbances of at least moderate severity that is, disturbances that are distinct in appearance and associated with a notable degree of subjective distress a 30% increase in mean negative mood ratings (relative to the range of the scale employed) in the premenstrual week compared with the week following the end of menses in at least two of three cycles age 18 to 50 not pregnant and in good medical health regular menses. For subjects with recurrent brief depression dysphoric mood or loss of interest or pleasure duration less than two weeks four of the following symptoms: poor appetite or significant weight loss (when not dieting) or increased appetite or significant weight gain; insomnia or hypersomnia; psychomotor agitation or retardation; loss of interest or pleasure in usual activities, or decrease in sexual drive; loss of energy; fatigue; feelings of worthlessness, self-reproach, or excessive or inappropriate guilt; diminished ability to think or concentrate, slowed thinking, or indecisiveness for all study participants Subjects should have no general medical illness that is primary (i.e., appears to be causing the mood disorder) Current antidepressant therapy (since this is a screening protocol for subsequent treatment and physiologic evaluation studies in which participants must be untreated). Antidepressants will not be withheld from participants who need or want them Current alcohol or substance use or dependence (excluding nicotine) of sufficient magnitude to require independent, concurrent treatment intervention (e.g., antabuse or opiate treatment, but not including self-help groups) Pregnant or lactating women Subjects who are unable to provide informed consent NIMH employees/staff and their immediate family members will be excluded from the study per NIMH policy | 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, Parathyroid Neoplasms Patients over the age of 2 who are enrolled in 91-DK-0085, "Studies of Hyperparathyroidism and Related Disorders", or patients who are undergoing parathyroid localization as part of routine patient care while enrolled in other Clinical protocols will be considered for the study Patients will be excluded if: There is any contraindication to arteriography. The Patient is pregnant | 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, Developmental Articulation Disorder Speech Disorder Stuttering i. Normal Language Development, Hearing and Cognition ii. The following screening tests previously published with norms were found to have a good distribution for determining normal functioning in adolescents and adults as all subjects did not hit ceiling and all had scores greater than or equal to the 80th percentile. These tests are being used to ensure that subjects affected with stuttering or FPPD do not have other disorders such as hearing loss, language delay, or mental retardation. Peabody Picture Vocabulary Test III (PPVT-III) Expressive Vocabulary Test (EVT) Oral Speech Mechanism Screening Examination Revised Token Test; Token test for Children Test of Non verbal intelligence (TONI-2) Digit Span subtest of the WICS-R Audiometric Screening Goldman Fristoe Test of Articulation WUG Test of Morphological Encoding Test of Auditory Comprehension of Language (TACL) Khan-Lewis Phonological Analysis FOR AND The Stuttering Severity Index -3 (Riley, 1981) has been found to be accurate for identifying and assessing the severity of stuttering during conversational speech. For the of a stuttering subject we require: i. A total overall score of 11 or greater between 3 and 17 years, ii. A total overall score of 18 or greater from age 18 and above. FOR FPPD: i. A family history of an autosomal dominant pattern of inheritance of the speech disorder over several generations with persistence into adulthood in some cases, ii. Speech symptoms during conversational speech deletion of final consonants; syllable reduction and syllable deletion; deletion of grammatical markers such as copulas, auxiliaries, prepositions, connectives; poor ability to self-correct; poor awareness of errors; and consonant cluster reduction. iii. Greater than 9% discourse errors during analysis of a sample of 300 syllables. iv. A discrepancy of 30 points (1 and 1/2 Standard Deviations) between receptive (the higher score) and expressive percentile score on the PPVT III and Expressive Vocabulary Test. v. For subjects greater than 7 years of age, a phonological process rating of 3 or more for any phonological process on the Khan-Lewis Phonological Analysis. For subjects less than 7 years of age, a phonological process rating of 3 or more on 2 phonological processes on the Khan-Lewis Phonological Analysis. Finally, any subjects with a non developmental phonological process error will be identified as potentially having FPPD i. Anyone with a hearing loss will be excluded from participation during the diagnostic testing. ii. Children with delayed language, more than 1 year delay from norms on receptive and expression language testing will be excluded. iii. Language impairment: scores more than 2 standard deviations below the age appropriate score on the standardized language tests listed under the criteria. iv. Cognitive impairment: scores more than 2 standard deviations below the age appropriate score on the standardized cognitive tests listed under the criteria. v. Bilingual non-native English speakers Studies have demonstrated that brain organization for speech and language may differ in bilingual persons. It is hypothesized that this may alter speech motor learning and thus kinematic data from non-native English speakers would differ from native English speakers. Therefore, only native-American English speakers, with only one language spoken in the home, will be included | 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): 8.0-99.0, Pulmonary Disease Patients 8 years old and older with signs or symptoms of pulmonary disease of medical interest to the professional staff of CPB will be eligible for participation in this protocol. Only standard diagnostic procedures and conventional therapy will be performed. Patients will not be subjected to any research procedures. This protocol does not commit the NIH to medical or surgical treatment of protocol participants after discharge. Patients will be discharged to the referring physician. Consenting to pregnancy testing in minors of childbearing age: We will inform the minor during the assent process that for safety, we need to do a pregnancy test. She will also be told that if it is positive, we will counsel her and help her tell her parents. If the minor does not want to proceed she will be advised not to sign assent and her enrollment on this training protocol will end Patients without symptoms of pulmonary disease will be excluded from this protocol | 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, Bereavement Depressive Disorder Immunologic Disease Mental Disorder Sleep Disorder People over the age of 50 who have lost their spouse within the last three 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): 20.0-34.0, Lead Poisoning Infertility married women who currently reside in two study areas in Shenyang, China between 20 and 34 years of age never smokers have obtained permission to have a child are attempting to become pregnant over the course of 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): 7.0-60.0, Mood Disorder for children with DMDD, subthreshold DMDD: 1.1.1 Ages 7-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25. 1.1.2 Abnormal mood (specifically, anger, sadness, and/or irritability), present at least half of the day most days (or at least half the day at least one day per week for subthreshold), and of sufficient severity to be noticeable by people in the child s environment (e.g. parents, teachers, peers). 1.1.3 Compared to his/her peers, the child exhibits markedly increased reactivity to negative emotional stimuli that is manifest verbally or behaviorally. For example, the child responds to frustration with extended temper tantrums (inappropriate for age and/or precipitating event), verbal rages, and/or aggression toward people or property. Such events occur, on average, at least three times a week. For subthreshold DMDD such tantrums occur on average at least once per month. 1.1.4 The symptoms in # 1.1.2, and 1.1.3 above are currently present and have been present for at least 12 months without any symptom-free periods exceeding three months. 1.1.5 The onset of symptoms must be prior to age 10 years. 1.1.6 For DMDD the symptoms are severe in at least in one setting (e.g. violent outbursts, assaultiveness at home, school, or with peers) and at least mild (distractibility, intrusiveness) in a second setting. For subthreshold DMDD, there must be evidence of impairment causing distress to the child or to those around him/her in at least one setting. 2. Parents of children and adolescents with DMDD or subthreshold DMDD enrolled in 02-M-0021 2.1.1. Are capable of performing behavioral tasks and/or scanning. 2.1.2. Speaks English 3. Healthy Volunteer (Control) Children 3.1.1. Control subjects will be group matched to the patients. 3.1.2. Have an identified primary care physician. 3.1.3. Speaks English 4. Healthy Volunteer Adults 4.1.1 Control subjects will be group matched to the patients. 4.1.2. They will have normal physical and neurological examinations by history or checklist 4.1.3. Have an identified primary care physician. 4.1.4 Speaks English 5. Children with Major Depressive Disorder (MDD) (all must be met): 5.1.1 Ages 11-17 at the time of recruitment; will be followed in the longitudinal component of the study until age 25. 5.1.2. DSM-IV or DSM-5 Major Depressive Disorder 5.1.2.1 Five or more of the following symptoms have been present during the same 2-week period and represent a change from previous functioning; at one of the symptoms is either (1) depressed mood or (2) loss of interest or pleasure. 5.1.2.1.1 Depressed mood most of the day, nearly every day, as indicated by either subjective report (e.g., feeling sad, blue, down in the dumps, or empty) or observation made by others (e.g., appears tearful or about to cry). (In children and adolescents, this may present as an irritable or cranky, rather than sad, mood.) 5.1.2.1.2 Markedly diminished interest or pleasure in all, or almost all, activities every day, such as no interest in hobbies, sports, or other things the person used to enjoy doing. 5.1.2.1.3. Significant weight loss when not dieting or weight gain (e.g., a change of more than 5 percent of body weight in a month), or decrease or increase in appetite nearly every day. 5.1.2.1.4. Insomnia (inability to get to sleep or difficulty staying asleep) or hypersomnia (sleeping too much) nearly every day 5.1.2.1.5. Psychomotor agitation (e.g., restlessness, inability to sit still, pacing, pulling at clothes or clothes) or retardation (e.g., slowed speech, movements, quiet talking) nearly every day 5.1.2.1.6. Fatigue, tiredness, or loss of energy nearly every day (e.g., even the smallest tasks, like dressing or washing, seem difficult to do and take longer than usual). 5.1.2.1.7. Feelings of worthlessness or excessive or inappropriate guilt nearly every day (e.g., ruminating over minor past failings). 5.1.2.1.8. Diminished ability to think or concentrate, or indecisiveness, nearly every day (e.g. appears easily distracted, complains of memory difficulties). 5.1.2.1.9. Recurrent thoughts of death (not just fear of dying), recurrent suicidal ideas without a specific plan, or a suicide attempt or a specific plan for committing suicide 5.1.2.1.10 Symptoms cause clinically significant distress or impairment in social, occupational/academic, or other important areas of functioning. 5.1.2.1.11. The episode is not attributable to the physiological effects of a substance or to another medical condition. 5.1.3. Youth with MDD who are continuing in research as adults must also be receiving psychiatric care for their MDD, if it is ongoing 6. Children with Attention-Deficit/Hyperactivity Disorder (ADHD) 6.1.1. Age 8-17 6.1.2. Currently meets DSM-IV or DSM-5 for ADHD 6.1.3. Subjects with other primary psychiatric disorders including anxiety disorders, dysthymic disorder, past major depression, oppositional defiant disorder, tic disorders, and the learning, communication, and elimination disorders may be accepted 6.1.4. Have an identified primary care physician. 6.1.5. Speaks English for those with DMDD: 1.3.1 The individual exhibits any of these cardinal bipolar symptoms: 1.3.1.1 Elevated or expansive mood 1.3.1.2 Grandiosity or inflated self-esteem 1.3.1.3 Decreased need for sleep 1.3.1.4 Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences) 1.3.1.5. Has BD symptoms in distinct periods lasting more than 1 day. 1.3.2. Meets for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD. 1.3.3. IQ< 70 1.3.4. The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition. 1.3.5. Currently pregnant or lactating 1.3.6. Meets for alcohol or substance abuse with the last three months 1.3.7. NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy. 2. of parents of children and adolescents with DMDD or subthreshold DMDD 2.1Are an NIMH IRP Employees/staff 2.2Have an I.Q. < 70 2.3 Have any serious medical condition or condition that interferes with participation 3.2 Healthy Volunteer 2.1. I.Q. < 70; 3.2.2. Any serious medical condition or condition that interferes with fMRI scanning pregnant or lactating; 3.2.3. Past or current diagnosis of any anxiety disorder (panic disorder, GAD, Separation Anxiety Disorder, Social Phobia), mood disorder (manic or hypomanic episode, major depression), OCD, PTSD, Conduct Disorder, psychosis, current suicidal ideation, Tourette Disorder, Autism Spectrum Disorder or ADHD. 3.2.4. Substance abuse within two months prior to study participation or present substance abuse 3.2.5. History of sexual abuse. 3.2.6. Parent or sibling with Bipolar Disorder, recurrent MDD, or any disorder with psychosis. 3.2.7. NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy. 4.2 Healthy Volunteer Adult 2.1. IQ< 70 4.2.2. Pregnant 4.2.3. Any past or current history of Bipolar Disorder (any manic or hypomanic episode), recurrent MDD, or any disorder with psychosis 4.3.3 NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy. 5.3<TAB> for those with MDD: 5.3.1<TAB>The individual exhibits any of these cardinal bipolar symptoms: 5.3.1.1<TAB>Elevated or expansive mood 5.3.1.2<TAB>Grandiosity or inflated self-esteem 5.3.1.3<TAB>Decreased need for sleep 5.3.1.4<TAB>Increase in goal-directed activity (this can result in the excessive involvement in pleasurable activities that have a high potential for painful consequences) 5.3.1.5. Has BD symptoms in distinct periods lasting more than 1 day. 5.3.2. Meets for schizophrenia, schizophreniform disorder, schizoaffective illness, PDD, or PTSD. 5.3.3. IQ< 70 5.3.4.<TAB>The symptoms are due to the direct physiological effects of a drug of abuse, or to a general medical or neurological condition. 5.3.5.<TAB>Currently pregnant or lactating 5.3.6.<TAB>Meets for alcohol or substance abuse with the last three months 5.3.7.<TAB>NIMH IRP Employees/staff and immediate family members will be excluded from the study per NIMH policy. 6.2.<TAB> for those with ADHD: 6.2.1. IQ<70 6.2.2.<TAB>Pregnancy (excludes for scanning only) 6.2.3.<TAB>Ongoing medical illness or neurological disorder other than ADHD 6.2.4.<TAB>Any condition that would interfere with the participants ability to perform research tasks 6.2.5. Current Major Depression 6.2.6. Any past or present manic or hypomanic episode For all groups: NIMH employees are 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): 18.0-999.0, Depression Pain You must be suffering from symptoms of depression for at least the past 2 weeks (sadness, loss of interest in daily activities, feelings of hopelessness or guilt, sleeplessness or lack of energy) You must have pain symptoms with no known cause, such as unexplainable, head, chest, or back pain, overall aches and pains, or other unexplainable pains You need to be available to visit a doctor's office about once a week for 10 weeks You are a woman and are pregnant or breastfeeding You have a current or previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorder You have had a primary diagnosis of an anxiety disorder within the past 6 months You have a history of alcohol or drug dependence or abuse within the past 6 months You have a serious medical 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, Major Depressive Disorder You must be at least 18 years old You must have been diagnosed with major depressive disorder You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks You are a woman and are pregnant or breastfeeding You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder You have had a primary diagnosis of an anxiety disorder within the past 6 months You have a history of alcohol or drug dependence or abuse within the past 6 months | 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, Major Depressive Disorder You must be at least 18 years old You must be diagnosed with major depressive disorder You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks You are a woman and are pregnant or breastfeeding You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder You have a history of alcohol or drug dependence or abuse within the past 6 months You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once You have a serious medical illness | 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): 0.0-45.0, Depression Mothers and infants must meet certain to be included in the study. Selection are: maternal age between 20 and 45 years, ability to read and write in English, normal pregnancy/delivery status without birth complications, term birth (+/ days from due date), and singleton status of the child. Approximately equal numbers of male and female infants will be recruited, and to the extent possible, the two groups of depressed and nondepressed mothers will be matched on ethnic composition. Participants will be seen at 5, 12, and 24 months None | 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, Colorectal Cancer Histologically confirmed adenocarcinoma of the colon Stage IIB or III (Dukes stage B2 or C) Complete curative resection performed within the past 7 weeks (negative margins) No local or regional relapsed disease Tumor more than 15 cm above the anal margin Carcinoembryonic antigen less than 5 ng/mL (after surgery) No rectal cancer No metastatic disease Age and over Performance status ECOG 0-1 OR | 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): 18.0-85.0, Depression Minor Depression symptoms for at least 6 months Endorse one of the DSM-IV "A" for MDD and at least one other symptom of MDD or endorse both of the "A" for MDD Global Assessment of Functioning (GAF) score < 70 Short form health survey (SF-36) social functioning score <= 75% or an emotional role functioning score <= 67% HAM-D-17 score 10-17, inclusive Minor depression symptoms for at least 6 months Major depressive disorder (MDD) or dysthymia within the past year or in partial remission of MDD At least a 12-week course of either citalopram at a minimum or 40 mg/day or St. John's Wort at a minimum of 900 mg/day during the current episode of depression Previous intolerance to either citalopram or St. John's Wort or history of nonresponse to either citalopram at a minimum of 40 mg/day or St. John's Wort at a minimum of 900 mg/day for at least 12 weeks Unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic, or hematologic disease Uncontrolled seizure disorder The following DSM-IV diagnoses: organic mental disorders; substance use disorders, including alcohol, active within the last year or patients with a positive urine drug screen; schizophrenia; delusional disorder; psychotic disorders not elsewhere classified; bipolar disorder; bereavement; adjustment disorder; antisocial personality disorder; panic disorder, social phobia, generalized anxiety disorder (GAD), or obsessive compulsive disorder (OCD). Patients may have a lifetime diagnosis of an anxiety disorder as long as it is not current Mood-congruent or mood-incongruent psychotic features Psychotropic drugs Hypothyroidism Investigational psychotropic drugs within the last year | 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, Epilepsy Major Depressive Disorder (MDD) Primary diagnosis of MDD with current duration lasting 12 weeks but no greater than 2 years Generally in good health Subject must read and write at a level sufficient to provide written informed consent Current or past history of seizure disorder Subject has a primary diagnosis or received treatment for panic disorder, obsessive compulsive disorder (OCD), post traumatic stress disorder (PTSD), acute stress disorder, Bipolar I or II disorder, schizophrenia, or other psychotic disorder Currently using illicit drugs or other psychotropic drugs Patient poses a current suicidal risk or has attempted suicide in the past 6 months | 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, Depressive Disorder, Major Major Depressive Disorder (MDD) Diagnosis of Major Depressive Disorder (MDD) Current major depressive episode at screen at least 2 months duration Must be at least 60 years of age Patients with a primary diagnosis other than MDD Patients with a history of schizophrenia, schizoaffective disorder, bipolar disorder or dementia Patients with a history of brief depressive episodes lasting less than 8 weeks Patients receiving formal psychotherapy within 12 weeks of study Patients who are suicidal Patients who have received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening Patients with a history or seizure disorders | 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, Depression Mood Disorders Major Depresssion General patient 1. Male or female subjects, 18 to 65 years of age. 2. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document. 3. Subjects must fulfill DSM-IV for Major Depressive Disorder (MDD) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, SCID-P. 4. Subjects must have an initial score of at least 20 on the MADRS at screen and at baseline of study phase I. 5. Subjects must have failed to respond in the past to an adequate dose and duration of at least one antidepressant (SSRI, bupropion, or venlafaxine) during a depressive episode 6. Current depressive episode of at least 4 weeks duration. Additional for substudy 4 (patients with MDD) 1. Age of onset less than 40 years of age. 2. Subjects with MDD must fulfill DSM-IV for Major Depression single episode or recurrent without psychotic features based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). 3. A failed adequate trial of ECT would count as an adequate antidepressant trial. 4. In women of childbearing age, a negative pregnancy test within 24 hours of MRI. for healthy control subjects (Substudy 4 only) 1. Age 18-65 years. 2. Written informed consent completed General patient Current or past diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV. 2. Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 3 months. 3. Female subjects who are either pregnant or nursing. 4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. 5. Subjects with uncorrected hypothyroidism or hyperthyroidism. 6. Subjects with one or more seizures without a clear and resolved etiology. 7. Treatment with a reversible MAOI within 4 weeks prior to study phase I. 8. Treatment with fluoxetine within 5 weeks prior to study phase I. 9. Treatment with any other concomitant medication not allowed (Appendix A for Substudy 2; Appendix G for Substudy 4) 14 days prior to study phase I. 10. No structured psychotherapy will be permitted during the study. 11. Current NIMH employee/staff or their immediate family member. Additional for substudy 2 (patients with MDD) 1. Previous treatment with ketamine or hypersensitivity to amantadine. Additional for Substudy 4 (patients with MDD) 1. Subjects who currently are using drugs (except for caffeine or nicotine), must not have used illicit substances in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening. 2. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications. 3. Clinically significant abnormal laboratory tests. 4. For imaging procedures, Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip). 5. Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of >4 for healthy control subjects (Substudy 4 only) 1. Current or past Axis I diagnosis 2. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips). 3. Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications. 4. Treatment with any of the exclusionary medications detailed in Appendix G 14 days prior to Phase 1 of the Substudy 4. 5. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine). 6. Presence of psychiatric disorders in first-degree relatives. 7. Female subjects who are either pregnant or nursing. 7.8.Current NIMH employee/staff or their immediate family member | 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): 18.0-64.0, Depressive Disorder, Major Major Depressive Disorder (MDD) Subjects must have the ability to comprehend the key components of the consent form Subject must have met DSM-IV-TR (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision) for current MDE (major depressive episode) for at least 8 weeks prior to the Screening Visit If female, subjects must be practicing an acceptable method of birth control Subjects must have rating scores as outlined Subjects whose symptoms of the MDE are better accounted for by another diagnosis Subjects with a history of schizophrenia, schizoaffective disorders or bipolar disorder Subjects have a positive urine test for illicit drug use and/or a history of substance abuse or alcohol dependence within the past 12 months Subjects with an unstable medical disorder If female, pregnant or lactating Subjects who have received ECT (electroconvulsive therapy) or TMS (transcranial magnetic stimulation) within the 6 months preceding screening or who have ever been homicidal | 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, Depression Age: 18-55 ICD-10 diagnoses F32.0, F32.1, F33.0, F33.1 Speak fluent danish Not able to do exercise Drug/alcohol addict The patient already engages in more than one hour of weekly exercise The patient has not been working the last 24 months due to depression Suicidal behavior | 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): 18.0-70.0, Major Depressive Disorder Primary diagnosis by DSM-IV for Major Depressive Episode, single or recurrent episode as confirmed by the Structured Clinical Interview for the DSM-IV (SCID-IV), with the additional stipulation of a duration for this episode of greater than or equal to 4 weeks and CGI-S greater than or equal to 4 Duration of current episode of depression less than 3 years (the definition of an episode is demarcated by a period of greater than or equal to 2 months when the patient did not meet full for the DSM-IV definition of major depressive episode) Total HAM-D17 score of greater than or equal to 20 and Item 1 score greater than or equal to 2 at screening visit Medication resistance to at least two different antidepressant treatments, defined as resistance to a minimum of 1 and a maximum of 4 antidepressant drug trials of adequate dose and duration in the current episode with adequate dose and duration defined as minimum level 3 on the Antidepressant Treatment History Form (ATHF); or, if patient has not received a sufficient number of antidepressant treatments to assess their medication resistance in the current episode, then the patient must meet level 3 medication resistance by ATHF to at least 1 and no more than 4 drug trials in a previous episode Patients who have not completed antidepressant trials of adequate dose and duration due to intolerance to therapy may be included if they have demonstrated intolerance to greater than or equal to 4 anti-depressant medications in the current or a previous episode, and did not meet ATHF for a single adequate treatment trial in the current episode Capable and willing to provide informed consent Signed HIPAA authorization Able to adhere with the treatment schedule, and withdrawal of ongoing pharmacotherapy If currently taking antidepressant pharmacotherapy, must be clinically appropriate to discontinue treatment with those agents Investigators, site personnel directly affiliated with this study, and their immediate families (immediate family is defined as a spouse, parent, child or sibling, whether by birth or legal adoption) Individuals diagnosed by the Investigator with the following conditions (current unless otherwise stated) Depression secondary to a general medical condition, or substance-induced Seasonal pattern of depression as defined by DSM-IV History of substance abuse or dependence within the past year (except nicotine and caffeine) Any psychotic disorder (lifetime), including schizoaffective disorder, or major depression with psychotic features in this or previous episodes Bipolar disorder Eating disorder (current or within the past year) Obsessive compulsive disorder (lifetime) Post-traumatic stress disorder (current or within the past year) | 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): 21.0-70.0, Depression Male or female subjects, 21 to 70 years of age. 2. Female subjects who are not of childbearing potential (i.e., surgically sterile, postmenopausal for at least one year) or must be using a medically accepted means of contraception. Women using oral contraceptive medication for birth control must also be using a barrier contraceptive. Women of childbearing potential must also have a negative serum Beta-HCG (human chorionic gonadotropin) at pre-study. 3. Subjects must fulfill DSM-IV for Major Depression (296.3) without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview, the Structured Clinical Interview for DSM-IV TR Axis I Disorders, SCID-P. 4. Subjects have a history of at least one previous episode of depression prior to the current episode. 5. Subjects must have an initial score of greater than or equal to 32 on the Inventory of Depressive Symptoms, Clinician version (IDS-C) at Visit 1 and Visit 2. 6. Subjects must not have greater than a 25% decrease in the IDS-C total scores during washout (between Visits 1 and 2). 7. Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document. 8. Current major depressive episode of at least 4 weeks duration. 9. Subjects who have not responded to adequate previous trials of at least one antidepressant as determined by the Antidepressant Treatment History Form (ATHF) (score greater than or equal to 3). Additionally, patients who have not completed antidepressants trials of adequate dose and duration due to intolerance to therapy may be induced if they have demonstrated intolerance to greater than or equal to 3 antidepressant medications in the current or a previous episode, and did not meet ATHF for a single adequate treatment trial in the current episode. 3 intolerant trials would count as an adequate failed trial. If this has not been met, the Principal Investigator may allow for a four-week prospective trial of a standard antidepressant (at the patients' and clinicians' discretion) for potential participants who have not responded to at least one adequate trial for the current episode per criteria Presence of psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder or bipolar disorder as defined in the Diagnostic and Statistical Manual, Version IV (DSM-IV). 11. Subjects with a diagnosis of Obsessive Compulsive Disorder as defined in the DSM-IV. 12. Subjects reporting Borderline or Antisocial Personality disorders. Other Axis II disorders do not qualify one for from the study. 13. Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for nicotine or caffeine) within the preceding 3 months. 14. Female subjects who are either pregnant or nursing. 15. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease. 16. Subjects with a history of neutropenia or medication-induced blood dyscrasia. 17. Clinically significant abnormal findings of laboratory parameters, physical examination, EEG, or ECG. 18. Subjects with a lifetime history of autism, mental retardation, pervasive developmental disorders, or Tourette's syndrome. 19. Subjects with uncorrected hypothyroidism or hyperthyroidism. 20. Subjects with one or more seizures without a clear and resolved etiology. 21. Treatment with a reversible monoamine oxidase inhibitor (MAOI) within 2 weeks prior to Visit 2. 22. Treatment with fluoxetine within 4 weeks prior to Visit 2. 23. Treatment with clozapine or electroconvulsive therapy (ECT) within 3 months prior to study Visit 2. 24. Judged clinically to be at serious suicidal or homicidal risk. 25. Participation in a clinical trial of another investigational drug within 1 month prior to study entry (visit 1). 26. Patients starting hormonal treatment (e.g., estrogen) in the last 3 months prior to visit 1. 27. Patients undergoing current nonpharmacologic antidepressant treatments, such as light therapy and psychotherapy. 28. Patients will be excluded who have previously failed greater than or equal to 3 lifetime adequate antidepressant trials by ATHF (Sackeim 2001). 29. Patients with any evidence of a seizure disorder as assessed by an EEG with photic stimulation. AND FOR PET SCANS ONLY: WITH MAJOR WILL IN THE OF THIS STUDY. 1. Subjects who are ages 21-70. 2. Subjects with an early age of onset (before age 40). 3. Subjects who either meet melancholic subtype and/or have a first degree relative with bipolar disorder. 4. Negative pregnancy test within 24 hours of positron emission tomography (PET) in women of childbearing potential. 1. Subjects will have been off psychotropic drugs (including zolpidem) for at least 3 weeks (8 weeks for fluoxetine) prior to PET. 2. Subjects with a history of lifetime DSM-IV substance dependence (except for nicotine or caffeine). 3. Subjects with substance abuse within 12 months (except for nicotine or caffeine). 4. Subjects with a current or lifetime history of hypertension or diabetes. 5. Subjects who have reached the annual research radiation exposure limit | 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, Seasonal Affective Disorder History of recurrent major depressive episodes with winter-type seasonal pattern by Diagnostic and Statistical Manual of the American Psychiatric Association, 4th Ed. (DSM-IV) (American Psychiatric Association, 1990), based on diagnostic interview utilizing the Structured Clinical Interview for DSM-IV Axis I Disorders (SCID) and graphic diagnostic tool Free of medical illness, not pregnant, as determined by detailed history and physical examination including blood and urine chemistries and thyroid function tests History of concurrent psychiatric illness that would preclude compliance with the protocol and ability to complete the study safely Active suicidal or homicidal ideation or plan Variable psychiatric symptoms such as rapid cycling or severe premenstrual syndrome that could interfere with accurate assessment of the treatment effect History of substance abuse/dependence with less than one year remission GAF < 50 Light treatment in the previous month Pregnant or lactating Antidepressant medications in the previous month Nightwork or other habitual alteration of sleep/wake cycle Medical conditions that affect mood or produce hallmark symptoms of mood disorder | 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 Patients must have documented advanced, locally recurrent, or metastatic head and neck carcinoma, which is untreatable by surgical resection or radiation therapy Prior chemotherapy for advanced/metastatic disease is allowed (1 regimen only) Patients must be taxane-naïve (no prior docetaxel or paclitaxel) Patients who have received chemoradiation as a primary therapy for advanced head and neck cancer are eligible Patients must have measurable or evaluable disease. Pre-study imaging for disease assessment must be done within 28 days of registration Patients with brain metastases are eligible if they have been stable for at least six weeks post-radiation therapy Aged 18 years or older Performance status of 0-2 by Zubrod criteria Life expectancy of at least 12 weeks Hematologic: absolute neutrophil count (ANC) equal to or > 1,500/mm3; hemoglobin equal to or > 8.0 g/dl; platelets equal to or > 100,000/mm3 Patients with congestive heart failure, second or third degree heart block or recent myocardial infarction within 12 months from registration are not eligible Peripheral neuropathy equal to or greater than grade 2 Patients with a history of severe hypersensitivity reaction to drugs formulated with polysorbate 80 Use of standard chemotherapy or investigational agents for treatment of head and neck cancer within 28 days of 1st dose of study drug Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil Pregnant or lactating women, women of childbearing potential with either a positive pregnancy test (PPT) at baseline, or sexually active females not using a reliable contraceptive method while on study and for at least six months after chemotherapy. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential.) Sexually active patients not using a reliable contraceptive method while on study and for at least six months after chemotherapy Patients with malabsorption syndromes will be excluded. Administration of capecitabine through feeding tubes is permitted Serious concurrent infections | 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): 21.0-70.0, Depression Diagnosis of major depression with a current episode Hamilton Rating Scale for Depression score higher than 20 No response or intolerance to antidepressant medication in the current depressive episode Current use of antidepressants Diagnosis of psychosis or anxiety disorder Current substance abuse Seizures or history of head trauma | 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, Depressive Disorder, Major Primary DSM-IV diagnosis of MDD Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) | 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, Schizophrenia Schizoaffective Disorder Major Depression Bipolar Disorder Coronary Artery Disease Patients meeting Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) for schizophrenia (or schizoaffective disorder), major depression, or bipolar (depressed phase) disorder who are treated with antipsychotic, antidepressant or antimanic drugs and a lipid-lowering drug (statin) for 2 months or longer will be screened to participate in the proposed project Based upon the CAD risk determinants (see below) and the National Cholesterol Education Program (NCEP) recommendation of goals for LDL-lowering therapy, the investigators will only enroll schizophrenic patients with baseline (before statin treatment) LDL-cholesterol exceeding mg/dL having CAD and CAD risk equivalents, e.g., peripheral arterial disease, abdominal aortic aneurysm, symptomatic carotid artery disease, and diabetes, as well as multiple risk factors that confer a 10-year risk for CAD > 20% mg/dL having 2 or more risk factors; and mg/dL having less than 2 risk factors to participate in the EPA trial. In addition, these CAD-risk patients have not reached the NCEP goal level within the past year following statin treatment Risk factors for CAD. The NCEP Expert Panel (NIH Publication No. 01-3670, May 2001) on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III or recognizes the following CAD risk factors being male, 45 years or older, or being female 55 years or older family history of premature CAD current cigarette smoking Patients with history of bleeding disorders, current drug or alcohol abuse (within one month), neurological disorders (including head injury with loss of consciousness for greater than 10 minutes), antisocial personality disorder, borderline personality disorder, or mental retardation as indicated in medical records Patients who are pregnant (as determined by urine pregnancy test) Patients who have already achieved their NCEP goal in terms of their lipid profile (as indicated in laboratory tests) will be 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): 40.0-65.0, Obesity Depression Age 40 to 65 Body Mass Index >= 30 Clinically significant depression PHQ score of 10 or more Current or past major depressive episode Current symptoms depressed mood or loss of interest Enrolled in Group Health Cooperative health plan History of treatment for bipolar disorder or schizophrenia Not willing to participate in group intervention Medical contra-indications to graded exercise program Unable to walk for 10 minutes | 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 people with Major Depressive 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): 6.0-20.0, Posttraumatic Stress Disorder Depression Admission to the Shriners Hospital or Massachusetts General Hospital for an acute burn, injury, or reconstructive surgery following a burn Between the ages of 6 years Recent experience of an acute burn, injury, or surgery meeting the Diagnostic and Statistical Manual(DSM-IV) A1 stressor criterion Child's response to the stressor meets Diagnostic and Statistical Manual(DSM-IV) A2 response criterion Proficiency in either English or Spanish No memory of the injury Current use of an anti-depressant Known hypersensitivity to sertraline Diagnosis of Bipolar Disorder Diagnosis of PTSD Mental Retardation Traumatic Brain Injury New onset or marked worsening of a seizure disorder | 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 For depressed subjects Meets DSM-IV diagnostic for major depressive disorder Score of greater than 16 on the Hamilton Depression Rating scale (17 items) at study entry Agrees to use an effective form of contraception throughout the study For healthy volunteers Not currently taking any medications No lifetime history of major neurological, medical, psychiatric disorder, or head injury Agrees to use an effective form of contraception throughout the study Current suicidal ideation that may make study participation unsafe Current serious or unstable medical illness (e.g., cardiovascular, kidney, liver, respiratory, endocrine, neurologic, or blood-related disease) History of seizure disorder History of or current DSM-IV diagnosis of any of the following psychiatric illnesses within 12 months of study entry: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, mood congruent or mood incongruent psychotic features, substance dependence disorders (including alcohol) History of or current diagnosis of dementia, or a score of less than 26 on the Mini Mental Status Examination at screening History of multiple adverse drug reactions or allergic reaction to the study drugs Currently taking psychotropic drugs or antidepressant medications Clinical or laboratory evidence of hypothyroidism Failure to respond during current major depressive episode to at least one adequate antidepressant trial, defined as 6 weeks or more of treatment with 40 mg of citalopram per day (or its antidepressant equivalent) History of electroconvulsive therapy (ECT) within the 6 months prior to study entry | 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): 18.0-70.0, Bipolar Disorder Criteria:Patients must meet the following to be eligible to participate in the study Male or female outpatients, 18 to 70 years of age Female patients of childbearing potential must be using a medically accepted means of contraception Able to communicate intelligently with the investigator, and study coordinator Able to give informed consent DSM-IV diagnosis of bipolar I, bipolar II, cyclothymic disorder or bipolar disorder not otherwise specified, experiencing an acute exacerbation of their illness at Visit 1 (hypomania, subsyndromal depression, hypomania and subsyndromal depression, depression and hypomania, or depression if diagnosed with bipolar II) as verified by SCID-I/P CGI-BP Overall Severity score greater than or equal to mildly ill at Visit 1 Must have been on prior medications for at least 2 weeks (6 weeks for fluoxetine) immediately prior to study entry Patients may not participate in the study if they have any of the following conditions Pregnant, nursing, or intending to become pregnant during the study Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease such that hospitalization for the disease is anticipated within 3 months or death is anticipated within 3 years A history of seizure disorder History of leukopenia without a clear and resolved etiology DSM-IV substance (except nicotine or caffeine) dependence within the past month Judged clinically to be at serious suicidal risk Participation in clinical trial of another investigational drug within 1 month (30 days) prior to study entry Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections prior to study entry Treatment resistance, non-response, or intolerability with olanzapine by the investigator's judgment | 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, Unipolar Depression Major Depression No physical health problems History of Epilepsy Metal in the head/neck or skull Pacemaker 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): 18.0-65.0, Major Depressive Disorder Depression Women, ages 18-65 years old Fulfilling DSM-IV for major depressive disorder, which is not secondary to another pre-existing psychiatric condition or to a medical condition Hamilton Depression Rating Scale (HAM-D-17) total score of at least 16 Able and willing to give meaningful written consent women premenopausal (having monthly periods); 28 women perimenopausal (having irregular periods); and 28 women menopausal (without a period for at least one year) In good physical health Subjects who are taking the birth control pill currently or within the last 3 months Subjects who plan to become pregnant or were pregnant within the last year Subjects who are taking hormone replacement therapy (or received it within the last three [3] months) Subjects who meet DSM-IV for substance abuse (consume > 4 alcoholic beverages per day) Subjects who have tried 2 antidepressants for this episode Subjects who have additional diagnosed psychiatric conditions (i.e. anxiety, substance use and psychotic disorders) Subjects who have had both ovaries surgically removed | 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): 12.0-999.0, Bipolar Disorder Age greater than or equal to 12 years Able to give basic informed consent Meets DSM-IV for Bipolar I, Bipolar II (if in the investigator's judgment long term treatment with a mood stabilizer is indicated), Bipolar NOS, or Schizoaffective Bipolar subtype Because many adolescents have shorter periods of mania or hypomania than those required by the DSM-IV (at least 4 days for hypomania and 7 days for mania) adolescents are included who have a current episode of MDD and a history of episodes mania/hypomania that lasted for at least 2 days Unwilling or unable to comply with study requirements (e.g., complete study forms, attend scheduled evaluations) Not competent to provide informed consent in the opinion of the investigator Mental retardation (IQ less than 70). Subjects suspected of mental retardation (e.g., chronic academic failure, multiple developmental delays) are evaluated using the Verbal Subtest of the Wechsler Intelligence test Presence of schizophrenia, schizoaffective pervasive developmental disorder, current substance or alcohol dependence, and organic mental disorder. Substance dependence in early remission is not an criterion Unstable medical illness or other medical contraindication to treatment with mood stabilizers, antidepressants or antipsychotic medications Women who are planning to become pregnant, pregnant or breast-feeding | 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): 18.0-70.0, Bipolar Disorder Alcohol Dependence English or Spanish-speaking Age 18-70 Diagnosis of bipolar I or II Current mood state of depressed or mixed Alcohol use of at least 5 drinks in the past 7 days Current diagnosis of alcohol dependence Bipolar disorders other than bipolar I or II disorders (e.g., bipolar NOS, or cyclothymic disorders, schizophrenia, schizoaffective disorder, or unipolar) Lifetime opiate abuse or dependence or any current use (including prescription drugs) Diagnosis of current dependence on substances other than alcohol (participants with only abuse of other substances are included. Dependence on caffeine and/or nicotine is allowed.) Severe or life-threatening medical illness (e.g., hepatic cirrhosis, congestive heart failure, terminal cancer) or labs consistent with serious medical illness (e.g., severe edema, atrial fibrillation, dangerously abnormal electrolytes) Pregnant or nursing female High risk for suicide defined as ≥2 suicide attempts in the past 12 months that required medical attention, or current suicidal ideation with plan and intent Prior therapy with naltrexone and/or allergic reaction to naltrexone Current therapy with acamprosate or disulfiram Member of a vulnerable population (Dementia, cognitively impaired, mental retardation, prisoner) Baseline YMRS or HRSD17 scores ≥ 30 | 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): 21.0-65.0, Depression Diagnosis of recurrent major depression Unstable medical illness Any other simultaneous psychiatric or medical illness of greater concern than depression (index episode of depression is not primary) | 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, Bipolar Disorder Diagnosis of bipolar disorder Currently in the third episode of mania or major depression History of one other episode of major depression within 5 years prior to study entry Currently in the first episode of mania or schizo-affective disorder (manic type) Rapid cycling drug or alcohol abuse Unstable medical illness Pregnant Index episode caused by medically prescribed drugs | 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): 20.0-60.0, Fibromyalgia Posttraumatic Stress Disorder Major Depressive Disorder Healthy volunteers without any current or past psychiatric disorder Current diagnosis of PTSD Current diagnosis of MDD Psychotic features | 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, Breast Cancer Major Depressive Disorder Women aged 18 years or older Diagnosis of breast cancer, confirmed by histopathology; Stages 0, I, II, IIIA, or IIIB Clinical diagnosis of Major Depressive Disorder (DSM-IV-TR) Hospital Anxiety and Depression Scale (Zigmond and Snaith, 1983) depression subscale score of 11 or greater Montgomery Asberg Depression Rating Scale (MADRS; Montgomery and Asberg, 1979) score of 25 or greater at Screening and Baseline visits Use of antidepressants in a previous episode of major depression or in the past for any other indication does not affect the patient's in this study During the current episode of major depressive disorder, as stated in the failure to respond to one or more adequate trials of an antidepressant will the patient from the study since this is not a study of "treatment-resistant depression" During the study, the patient may not use any other antidepressants Presence of another current clinically significant Axis I disorder like bipolar disorder, schizophrenia, or panic disorder Current (in past 6 months) comorbid active substance abuse or dependence Failure to respond to one or more adequate trials of an antidepressant in the current episode of MDD A reduction in MADRS score of 20% or greater from Screening to Baseline visit Clinically significant laboratory abnormalities that in the judgment of the Investigator would increase risk of adverse effects with bupropion Pregnant or lactating women History of an eating disorder, seizures, head injury, or other intracranial pathology because these conditions are usually contraindications to the use of bupropion XL Previous allergy or intolerance to bupropion Patients judged to be at significant suicidal risk | 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 Lung Non-Small Cell Carcinoma Stage IA Lung Non-Small Cell Carcinoma AJCC v7 Stage IB Lung Non-Small Cell Carcinoma AJCC v7 Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 Stage IIIA Lung Non-Small Cell Cancer AJCC v7 Stage IIIB Lung Non-Small Cell Cancer AJCC v7 Patients must have histologically or cytologically confirmed diagnosis of stage I, II or III non-small cell lung cancer; tissue blocks or slides will be requested Patients must have surgically resectable disease and may not be treated with prior chemotherapy or radiation Patients must be able to tolerate systemic chemotherapy prior to surgical resection No acute intercurrent illness or infection Eastern Cooperative Oncology Group (ECOG) performance status 0-1 Leukocytes >= 3,000/uL Absolute neutrophil count (ANC) >= 1,500/uL Platelets >= 100,000/uL Hemoglobin >= 8g/dL Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal Patients who have had prior chemotherapy or radiotherapy for lung cancer Patients may not be receiving any other investigational agents within 30 days of trial entry, including anti-EGFR drugs Patient has signs or symptoms of acute infection requiring systemic therapy Patient exhibits confusion, disorientation, or has a history of major psychiatric illness that may impair patient's understanding of the informed consent Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (New York Heart Association Functional Classification class II or worse), unstable angina pectoris, serious or clinically significant cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients refusing to sign the informed consent Patients with pre-existing peripheral neuropathy National Cancer Institute (NCI) Common Toxicity (CTC) grade 2 or worse Patients must not be pregnant or breast-feeding and all (male and female) must use a contraceptive method deemed acceptable by the investigator while receiving active treatment in the study and for up to two months following completion of therapy Patients with a history of severe hypersensitivity reaction to Taxotere and or polysorbate 80 must be 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): 21.0-70.0, Depression History of recurrent major depression Has a parent or sibling with a history of recurrent major depression Depression began before the age of 31 Bipolar I (manic-depressive) disorder Schizophrenia | 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, Depression Less than 24 weeks pregnant at the time of study entry As of 12/1/2005, at significant risk for developing depression or currently taking SSRIs during pregnancy History of or current psychosis, bipolar disorder, or schizoaffective disorder Current substance use disorder Any medical condition that may be related to outcomes (such as multiple births or insulin-dependent diabetes) Has not attended at least two prenatal visits at the 20-week intake point | 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 6 weeks postpartum English-speaking Score of at least 10 on the Edinburgh Postnatal Depression Scale DSM-IV diagnosis of bipolar disorder or psychotic episode Active substance abuse within 6 months prior to study entry Has not received obstetrical care History of a suicide attempt within 6 months of study entry | 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 Infections Depression Available for at least 9 months, or the duration of the study Willing to complete HIV testing and counseling History of HIV testing and counseling At high risk of HIV infection, indicated by more than one male sexual partner in the 3 months prior to study entry Meets for either (a) major depression or dysthymia within a mild-to-moderate level according to standard DSM-IV, or (b) minor depression as defined by one or more of the following symptoms at any time and for any duration during the past 12 months: significant weight loss or gain, or significant decrease or increase in appetite; poor sleep pattern; noticeable irritability or slowness; fatigue or lack of energy; inappropriate feelings of worthlessness or guilt; inability to concentrate; indecisiveness; and recurrent thoughts of death or suicide HIV infected Sexual intercourse in the 3 months prior to study entry with only one partner, and in a monogamous relationship Currently enrolled in another study involving repeated HIV testing and counseling Receiving treatment for depression with antidepressant medication for any length of time within the year prior to study entry Currently in psychotherapy, psychoanalysis, or any other form of talk therapy for any reason Severe depression or at suicidal risk No evidence or prior history of depression Homicidal or other similar problem that, in the opinion of the investigator, may endanger study staff and participants Currently taking monoamine oxidase inhibitors (MAOIs). Participants may be allowed to enroll 14 days after discontinuing use of a MAOI History of seizures | 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 Depression Participants must present with a first or new episode of DSM IV non-psychotic major depression warranting treatment with antidepressant mediation Must be able to give informed consent History of psychosis or mania/hypomania or personality disorder Non-English speaking or otherwise unable to provide historical information Having taken Omega-3 dietary supplements in the last 3 months History of allergy to Omega-3 supplements, finfish or shellfish Pregnancy, breast feeding or plans to become pregnant during course of study Post-natal depression Current drug or alcohol abuse or dependence or history of abuse or dependence over the last 12 months Unstable thyroid function Hepatic or renal impairment or other medical conditions that may interfere with the absorption and metabolism of Omega-3 polyunsaturated fatty acids Coagulopathy or anticoagulant treatment due to theoretical bleeding 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): 18.0-999.0, Depression Between 8 and 32 weeks of gestation at time of study entry A score above 12 on the Edinburgh Postnatal Depression Scale Speaks English Resides in the Pittsburgh, PA, area Access to a household telephone Currently receiving treatment for depression (i.e., medication or psychotherapy) History of a prior manic episode Alcohol or drug abuse or dependence within 6 months of study entry Psychotic disorder or organic mental disorder Suicidal, homicidal, or requires hospitalization Severe sexual and/or physical aggression in relationship with partner or husband Significant medical illness such as epilepsy, autoimmune disorder, liver dysfunction, or unstable endocrine disease Severe cognitive deficits that would prevent treatment with psychotherapy | 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 Major Depressive Disorder Males and Females Age: 18-50 Recurrent Major Depressive Disorder; current Major Depressive Episode with at least one prior episode HAM-D >16 Able to give written informed consent Agree to use a reliable means of birth control during the study, as determined by the investigator (females of child-bearing potential only) History of head injury or loss of consciousness for longer than 30 minutes Presence of primary anxiety disorder, bipolar I or II disorder, or psychotic disorders Presence of anorexia nervosa or bulimia nervosa Presence or history of epilepsy or other seizure disorders Presence of significant Axis II disorder based on investigator judgment Presence of significant unstable medical condition Presence or past history of ADHD or significant learning disability ECTs (unilateral) within the past 12 months or bilateral ECT (ever) More than 2 failed adequate antidepressant treatments in the current episode Pregnant or breast-feeding females | 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, Depressive Disorder, Major A primary diagnosis of MDD Depressive symptoms for at least 30 days before the screening visit Treatment with DVS SR at any time in the past Known hypersensitivity to venlafaxine Significant risk of suicide based on clinical judgment | 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): 35.0-999.0, Depression Heart Diseases Persistent depressive symptoms that may the following: depressed mood; diminished interest or pleasure in activities; change in appetite; insomnia or hypersomnia; psychomotor agitation or retardation; fatigue or loss of energy; feelings of worthlessness or inappropriate guilt; diminished ability to think or concentrate; or recurrent thoughts of death or suicidal ideations Documented history of coronary heart disease (i.e., a prior heart attack, coronary artery bypass graft, or greater than 75% stenosis in at least one coronary artery) Experienced an acute heart attack or any revascularization procedure (i.e., CABG or percutaneous transluminal coronary angioplasty) within 60 days of study entry Left ventricular ejection fraction <30% with labile ECG changes prior to testing Currently using a pacemaker Resting blood pressure greater than 160/100 mmHg Left main disease >50% Failure to meet our for depression or achieve a score of ≥9 on the Beck Depression Inventory-II Any other concurrent psychiatric intervention Primary psychiatric diagnosis other than Major or Minor Depressive Episode Primary diagnosis of the following psychiatric disorders: schizophrenia, bipolar disorder, schizoaffective disorder, other psychotic disorder, dementia, current delirium, current obsessive compulsive disorder Experienced psychotic symptoms during the current depressive episode | 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, Major Major Depressive Disorder (MDD) Primary diagnosis of Major Depressive Disorder (MDD) must have met DSM-IV for current major depressive episode for at least 8 weeks but no long than 2 years HAM-D17 total score of >17 at screening and baseline Severity of illness score of >4 at screening and baseline Willing to discuss sexual functioning with investigator or designee Sexual activity that leads to orgasm at least every 2 weeks Past or current DSM-IV diagnosis of Bipolar Disorder I or II, schizophrenia or another psychotic disorder(s) Primary DSM-IV diagnosis or received treatment for Panic Disorder, Obsessive Compulsive Disorder or Post Stress Disorder within previous 12 months Poses a homicidal or serious suicidal risk, have made an attempt within months prior to screening or who has ever been homicidal Myocardial infarction with 1 year of screening Taken ibupropion hydrochloride or venlafaxine in the last 6 months Positive urine test for illicit drug use or alcohol or substance abuse within the past 12 months Psychotherapy within 3 months Pregnant Electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior of screening ECG or clinical evidence of atrial or ventricular hypertrophy | 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): 19.0-64.0, Depression Clinical diagnosis of MDD (as defined by SCID [DSM III-R] and a score of at least 15 on the 21-item Hamilton Depression Scale) Able to swallow tablets, give urine and blood samples, and participate in periodic evaluations during the study Healthy volunteers show no current Axis I or Axis II disorders and score less than 8 on the Hamilton Depression Scale Use of any of the following medications within the 2 weeks prior to study entry: psychoactive medication; aspirin; or nonsteroidal anti-inflammatory agents Any alcohol or drug abuse within the 6 months prior to study entry Any major medical disorder | 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, Abortion, Induced Criteria:Healthy females: 1) 18 years of age or older, 2) requesting an elective termination of pregnancy by medical abortion, 3) with an intrauterine pregnancy no more than 63 days gestation on the day of mifepristone administration as documented by endovaginal ultrasound, 4) willing and able to sign informed consent, 5) willing to comply with the study protocol and visit schedule, 6) willing to have a surgical abortion/D&C if indicated, and 7) with easy and ready access to a telephone. - ultrasound evidence at the evaluation(s) prior to mifepristone treatment of an early pregnancy failure, 2) contraindication to mifepristone (known allergy to mifepristone, chronic corticosteroid administration, adrenal disease), 3) contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, poorly controlled seizure disorder, or known allergy to prostaglandin), 4) known or suspected extrauterine pregnancy, 5) known or suspected pelvic infection, 6) hemoglobin <10 mg/dL, 7) known clotting defect or receiving anticoagulants, 8) cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure), 9) current breastfeeding, 10) pregnancy with an IUD in situ, 11) current use of any experimental drug, 12) suspected or confirmed endometrial arteriovenous malformation, 13) active oral herpes lesions per subject report, 14) prior participation in this research study, or 15) current participation in another research study that, in the opinion of the investigator, would interfere with the conduct 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): 18.0-64.0, Depressive Disorder Diagnosis of major depressive disorder, as defined by DSM-IV and confirmed by the semi-structured MINI, recurrent episode Total score of less than 24 on the MADRS HAM-D total score less than 18 Duration of the current depressive episode less than 1 month or greater than 2 years Patients with a history or presence of bipolar disorders or psychotic disorders Patients with alcohol dependence or abuse or substance dependence or abuse in the past 12 months except nicotine or caffeine dependence Patients who have used the following prior to entry into Acute Phase: antipsychotics within 3 months, fluoxetine within 1 month, MAOIs within 2 weeks, other antidepressants, anxiolytics, or mood-stabilizer (lithium, anticonvulsants) within 1 week except as allowed in the protocol. The investigator will evaluate whether there are other reasons why a patient may not participate | 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, Depression Current DSM-IV diagnosis of major depressive episode, as determined by Structured Clinical Interview for DSM-IV (SCID-IV) Primary diagnosis of MDD, based on prominence of symptoms and target for intervention (comorbid anxiety disorders, except obsessive-compulsive disorder (OCD), will not be for exclusion) Score of at least 18 on the 17-item Hamilton Rating Scale for Depression (HAM-D17) Agrees to use an effective form of contraception and/or double barrier method Previously treated for major depression with either medication or psychotherapy Current psychosis, dementia, eating disorder, or dissociative disorder History of bipolar disorder (I and II) or schizophrenia Alcohol or drug dependence within 3 months prior to study entry or current alcohol or drug abuse (excluding nicotine and caffeine), as assessed by medical history and urine drug screening Requires neuroleptic or mood stabilizer therapy in addition to depression treatment Presence of any acute or chronic medical disorder that could affect successful completion of the trial Medical contraindications that would preclude treatment with escitalopram or duloxetine Presence of practical issues that would likely prevent completion of the study (e.g., planned geographical relocation) Pregnant or breastfeeding Medical conditions that could prevent the safe use of MRI (e.g., pacemaker, aneurysm clips, neurostimulators, cochlear implants, metal in eyes, or other implants; steel worker) | 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 Ages 18-65 Meet for current Major Depressive Disorder Antidepressant medication-free for at least 2 weeks prior to the start of the study Pregnant or breastfeeding women Anyone who is suicidal Anyone with an unstable medical condition (cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological), substance abuse problem within the past 6 months, psychoses (past or current), hypothyroidism, or hypomania Anyone currently taking an SSRI Past intolerance to Lexapro or Celexa | 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, Major Depressive Disorder Ability to provide written informed consent Current Major Depressive Episode (MDE), secondary to either Major Depressive Disorder or Bipolar Disorder (I, II or NOS), diagnosed by structured clinical interview for Diagnostic and Statistical Manual of Mental Disorders-IV-text revision (DSM-IV-TR) Current MDE at least two years duration OR a history of more than 4 lifetime depressive episodes Minimum score at study entry of 20 on the 17-item Hamilton Depression Rating Scale (HDRS-17) Average pre-operative HDRS-17 score of 20 or greater (averaged over four weekly pre-surgical evaluations during the four weeks prior to surgery) and an average pre-operative HDRS-17 score no more than 30% lower than the baseline screening HDRS-17 score A maximum Global Assessment of Functioning of 50 Treatment-resistant depression defined as Failure to respond to a minimum of four different antidepressant treatments, including at least three medications from at least three different classes, evidence-based psychotherapy or electroconvulsive therapy (ECT) administered at adequate doses and duration during the current episode Failure or intolerance of an adequate course of electroconvulsive therapy (ECT) during any episode (confirmed by medical records), or refusal of ECT due to a reason considered to be valid by the study psychiatrist A patient may remain on psychotropic medications during this study. However, doses must remain stable during the 4 weeks prior to surgery, the four weeks post-operatively, and the 24 weeks open stimulation phase. Medications will be changed only if intolerable side effects clearly attributable to the medications develop Inability to tolerate general anesthesia Significant cerebrovascular risk factors or a previous stroke, documented major head trauma or neurodegenerative disorder Other currently active clinically significant Axis I psychiatric diagnosis including schizophrenia, panic disorder, obsessive-compulsive disorder, generalized anxiety disorder or post-traumatic stress disorder. Patients with severe Axis II personality disorders will also be excluded if the personality disorder is likely to interfere with cooperation and adherence to the study protocol Current psychotic symptoms Evidence of global cognitive impairment Substance abuse or dependence not in full sustained remission (i.e., not active for at least one year) Active suicidal ideation with intent; suicide attempt within the last six months; more than three suicide attempts within the last two years Pregnancy or plan to become pregnant during the study period General contraindications for DBS surgery (cardiac pacemaker/defibrillator or other implanted devices) Inability or unwillingness to comply with long-term follow-up | 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) Patients with Major Depressive Disorder,score on depression rating scale reach a specific point(17 item Hamilton Depression Scale>18) patients use monoamine oxidase inhibitors (MAOIs), benzodiazepines, Chinese herbal medicines, acupuncture, moxibustion or other psychoactive medications other than zolpidem, zopiclone;diagnosed with other Axis I disorder other; not responsive to paroxetine therapy before; pregnant or lactating, have serious medical disorder or condition that would preclude the administration of paroxetine; have a history of seizure disorders (except for febrile seizures in childhood); require treatment with warfarin anticoagulants, phenytoin, cimetidine, sumatriptan, type 1C antiarrhythmics, quinidine or sulfonylurea derivatives; are substance abuse or dependence (alcohol or drugs) within 6 months prior to this trial; have had electroconvulsive therapy within 2 months of entry into the study; pose a current, serious suicidal or homicidal risk; have taken other psychotropic drugs or antidepressants other than MAO inhibitors within 7 days of baseline and MAO inhibitors within 14 days of baseline; have taken any investigational drug, or participated in a clinical trial within the past 3 months; are hypersensitivity to paroxetine; have undergoing formal psychotherapy/psychoanalysis | 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): 21.0-45.0, Depression Anxiety Disorders No more than 28 weeks pregnant at the time of study entry History of depression or anxiety Current symptoms of distress Score of 9 or greater on the Edinburgh Postnatal Depression Scale (EPDS) English-speaking Plans to move away from the area prior to giving birth Current use of steroids for medical conditions | 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, Estrogen Receptor-positive Breast Cancer HER2-positive Breast Cancer Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer Stage IV Breast Cancer Have a histologically confirmed diagnosis of primary breast carcinoma that has been surgically resected; (this regimen is not intended for neoadjuvant treatment) + nodes OR if 1-3 + nodes, either ER OR HER-2/neu+ OR have high-risk node negative disease that is HER-2/neu positive OR >= 2.0 cm tumor size HER-2/new + definition: patient has known tumor HER-2/new expression = 3+ by IHC or, if 2+ by IHC confirmed to be FISH positive Patients with clinically apparent cardiac disease, or history of same, are not eligible; patients who are >= 60 years of age or who have a history of hypertension must have an echocardiogram or MUGA prior to enrollment; patients with breast cancer that is HER-2/neu positive and a treatment plan that includes Herceptin must have an echocardiogram or MUGA scan prior to enrollment; the LVEF must be within the institutional normal range; if LVEF is > 75%, the investigator should consider having the LVEF reviewed or repeating the MUGA prior to registration WBC >= 4,000 ANC >= 1,500 Platelet count >= 100,000 Serum creatinine =< 1.5 x IULN Except for the following, no other malignancy is allowed: synchronous ipsilateral breast cancer of the same subtype (ER/PR, HER-2/neu), adequately treated basal cell or squamous cell skin cancer, in situcervical cancer or other stage I or II cancer from which the patient has been disease free for at least 5 years Patients with cardiac disease that would preclude the use of Adriamycin, Taxol or Herceptin are not eligible; this includes Angina pectoris that requires the use of antianginal medication Cardiac arrhythmia requiring medication Severe conduction abnormality Clinically significant valvular disease Cardiomegaly on chest x-ray Ventricular hypertrophy on EKG Uncontrolled hypertension, (diastolic greater than 100 mm/Hg or systolic > 200 mm/hg) Current use of digitalis or beta blockers for CHF | 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, Major Depressive Disorder DSM-IV diagnosis of major depression HAMD scale score of ≥20 despite at least two adequate antidepressant treatment trials during the current episode Underwent ECT treatment during the 3 months preceding the study Change in psychotropic medications doses during the 3 weeks preceding the study Concurrent unstable medical or neurological illness Patients are judged to be potentially violent towards themselves or others, or have a history of drug/alcohol abuse | 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, Colon Cancer adult colon cancer open surgery emergency surgery metastases | 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 depressive episode (MDE) associated with Major Depressive Disorder (DSM-IV-TR criteria) Duration of current episode is at least 12 weeks duration and less than 2 years Symptoms of decreased energy, pleasure, and interest Female subjects who agree to use acceptable methods of birth control throughout the study Current diagnosis of Panic Disorder, or symptoms of generalized anxiety or panic attacks that could interfere with their ability to complete the trial Symptoms of MDE better accounted for by another diagnosis Diagnosis of panic disorder / attacks, generalised anxiety, borderline or antisocial personality disorder, dementia, anorexia nervosa / bulimia (within 6 months of screening), bipolar disorder, schizophrenia or any other psychotic disorder(s) Started psychotherapy within 3 months prior to the Screening Received electroconvulsive therapy or transcranial magnetic stimulation within 6 months prior to screening Received psychoactive drugs within 4 weeks of randomization Positive urine drug screen or positive blood alcohol Suicidal risk or has had any previous suicide attempt, a family history of suicide attempt Positive pregnancy test History of seizure disorder, myocardial infarction (< 1yr), or unstable medical condition | 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): 18.0-70.0, Major Depressive Disorder Diagnosis of Major Depressive Episode (MDE) in the context MDD according to DSM-IV without psychotic features. 2. Hamilton Depression Scale (21 items, HAM-D) total >16 with item 1 (depressed mood) >2. 3. Age 18-70 years. 4. Male or female. 5. Competent and willing to give written informed consent Clinical hyper or hypothyroidism or any other thyroid illness. 2. Neurological or other medical illness that may impact upon the study or limit prescription of the study medications. 3. Significant suicidal risk [HAM-D item 3 (suicide) >2]. 4. Comorbidity with any Psychotic Disorder, Bipolar Disorder, Post Traumatic Stress Disorder (PTSD), Eating Disorder. 5. Lifetime history of substance or alcohol dependence or of abuse in the preceding 12 months. 6. Treatment with the antidepressant, sertraline, in current episode. 7. More then one antidepressant trial or any augmentation treatment during current episode. 8. Length of current episode >12 months 9. Female subjects pregnant or lactating or not using adequate contraception | 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): 0.0-999.0, HIV Infections Infants and children congenitally infected with HIV-1 | 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 Male Major Depression Disorder | 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, Hypertension Diabetes Hypercholesterolemia Vasculitis Coronary Heart Diseases All inpatients in a hospital environment Inability to give an 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): 18.0-65.0, Major Depressive Disorder (MDD) Key Diagnosis of major depressive disorder Key Females who are pregnant or nursing Electroconvulsive therapy within previous year Type 1 diabetes or uncontrolled type 2 diabetes HIV, Hepatitis B or Hepatitis C Use of illegal drugs, history of drug abuse, and/or alcohol dependence Clinically significant abnormal lab results Other protocol-defined may 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): 18.0-65.0, Depressive Disorder, Major Asian patients Male or female to 65 years outpatients DSM-IV-TR for Major Depressive Disorder Patients with cardiac conditions and other physical conditions contraindicated for drug study Shift worker Patients known to be non-responders to fluoxetine treatment Pregnancy, or breastfeeding | 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, Major Depressive Disorder Alcohol Abuse Alcohol Dependence DSM-IV diagnostic for MDD (diagnosis based on Structured Clinical Interview for DSM-IV, Patient Edition; SCID I/P) 2. Written informed consent 3. Men and women aged 18-64 years 4. Current diagnosis of alcohol abuse/dependence as per SCID I/P Subjects with suicidal ideation where outpatient treatment is determined unsafe by the study clinician. These patients will be immediately referred to appropriate clinical treatment. 2. Pregnant women or women of childbearing potential who are not using a medically accepted means of contraception (defined as oral contraceptive pill or implant, condom, diaphragm, spermicide, IUD, s/p tubal ligation, partner with vasectomy). 3. Known history of serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease. 4. History of seizure disorder, brain injury, any history of known neurological disease (multiple sclerosis, degenerative disease such as ALS, Parkinson disease and any movement disorders, etc.). 5. Clinical or lab evidence of untreated hypothyroidism. 6. History or current diagnosis of the following DSM-IV psychiatric illness: organic mental disorder, schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, bipolar disorder, patients with mood congruent or mood incongruent psychotic features, patients with substance use disorders (excluding alcohol and nicotine) active within the last 12 months. 7. Current use of other psychotropic drugs, including current use of benzodiazepines, hypnotics, anticonvulsants. Concomitant use of antihistamine drugs will be allowed. Patients will need to be off all antidepressants for at least two weeks by the time of the baseline visit, and four weeks for fluoxetine, and off benzodiazepines and other psychotropics for at least one week. The decision about whether to taper existing medications should be made by the individual and their primary treater based on clinical care and will not be made for purposes of study enrollment. allowed. 8. Patients who have failed to respond during the course of their current major depressive episode to at least two adequate antidepressant trials. An adequate antidepressant trial is defined as six weeks or more of treatment with escitalopram > 20mg/day or its antidepressant equivalent: (fluoxetine 40mg/day, sertraline > 100 mg/day, paroxetine > 40 mg/day, fluvoxamine > 100 mg/day, citalopram > 40 mg/day, escitalopram > 20 mg/day, venlafaxine > 150 mg/day, and duloxetine > 60 mg/day). 9. Any depression-focused or substance-abuse focused psychotherapy (family or marital counseling would be allowed). 10. Patients who have taken an investigational psychotropic drug within the past year. 11. Need for medical or inpatient detoxification from alcohol. This determination will be made by the screening clinician, based on clinical judgement as in the multicenter STAR*D study (PHRC #2000-P-001955 in accordance with methods used in the multi-center STAR-D 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): 18.0-80.0, Breast Cancer General health Women Age >18 ECOG Performance status 0-1 Life expectancy must be 3 months. Clinical stage Histologically or cytologically adenocarcinoma of breast Pre-operative stage II-III per AJCC 6th edition, based on baseline evaluation by clinical examination, breast imaging, and/or preoperative work-up Evidence of residual invasive breast cancer or node positive disease following neoadjuvant chemotherapy. Prior Therapy Patients must have received primary (neoadjuvant) chemotherapy for local or locoregional breast cancer containing an anthracycline and a taxane Patients must have completed definitive resection of primary tumor with adequate excision of gross disease Patients must have residual invasive carcinoma in the breast and/or residual carcinoma in one or more regional nodes following preoperative chemotherapy. Adequate hematologic and metabolic parameters within four weeks of study entry defined as Prior therapy No prior gemcitabine, continuous infusion 5-FU, or oral fluoropyrimidine (capecitabine, UFT, S-1, 5-FU/eniluracil, etc.) No known hypersensitivity to capecitabine or prior unanticipated severe reaction to (capecitabine, UFT, S-1, 5-FU/eniluracil, etc.) therapy or known hypersensitivity to 5-fluorouracil No concurrent or prior endocrine therapy as adjuvant treatment No prior breast radiation Current, recent (within 4 weeks of the first infusion of this study), or planned participation in another experimental drug study Stage IV breast cancer Patients must not have evidence of metastatic disease at enrollment. Women of child-bearing potential Nonpregnant and nonlactating Women of child-bearing potential must have a negative serum pregnancy test and must agree to an effective means of contraception during the entire study period. Concurrent medical conditions | 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): 18.0-70.0, Major Depressive Disorder Male and female adults, 18 through 70 years of age, inclusive Diagnosis of Major Depressive Disorder according to DSM-IV HAM-D17 total score > or = 22 at Screening and Baseline History of non-response to paroxetine Patients who have been previously treated with agomelatine History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder Any current Axis I disorder other than major depressive disorder which is the focus of treatment Substance or alcohol abuse in the last 30 days, dependence in the last 6 months Use of any psychoactive medication after the screening visit Female patients of childbearing potential who are not using effective contraception Other protocol-defined inclusion/ | 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): 45.0-65.0, Hormone Replacement Therapy Written informed consent Postmenopausal status (amenorrhea for at least 12 months) years of age Application of estrogen or cyclic estrogen/progestin preparation other than the study medication for at least 6 months prior to Visit 1 Relevant impairment of well-being and mood inspite of estrogen therapy (confirmed by questionnaire scores) BMI<33kg/m2 Uterine bleeding of unknown etiology within the last 2 years Previous or existing or suspected carcinoma of the breast Any malignant disease in the last 5 years Endometrial double layer thickness > 5 mm History of thromboembolic events or existing thromboembolic processes Prior hormone replacement therapy with androgens within 12 months prior to Visit 1 Major life events within the last 12 months prior to Visit 1 | 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): 25.0-60.0, Depression Males or females ages 25-60. Must be able to read and understand English. 2. Currently meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-IV) for a major depressive episode. (History of either unipolar major depression (depressive episodes only) or bipolar I disorder (history of manias and depressions) or bipolar II disorder (hypomanias and depressions), current episode depressed acceptable). 3. Must meet for "treatment resistant" depression defined by failure to respond to, or intolerance of, at least 2 treatment trials (antidepressants or ECT) during the current episode. 4. All subjects will be fully ambulatory and in good medical health. 5. Are required to either be antidepressant free for 2 weeks prior to study entry (4 weeks for fluoxetine secondary to long half-life) or be on a fixed psychotropic medication regimen for at least 4 weeks. Subjects and their primary care providers must agree to continue their status (i.e. without antidepressant or on a fixed regimen) until the 12-week assessment is complete. 6. Pre-menopausal female subjects must not be pregnant and must be willing to use adequate contraception during the study period Current or history of psychotic symptoms. 2. Active suicidal ideation (defined as a score of ≥3 on Hamilton Depression Rating Scale (HDRS) suicide item). 3. Prior use of a TNF-alpha antagonist (i.e. etanercept, infliximab, adalimumab) and use of any other immunosuppressant agent (i.e. systemic corticosteroids or anti-proliferative agents such as methotrexate) within one year of study entry. 4. Current use of aspirin, non-steroidal anti-inflammatory agents (NSAIDs) or cyclooxygenase-2 (COX-2) inhibitors during the study. Acetaminophen will be allowed. 5. History of any of the following conditions: Congestive heart failure, abnormal electrocardiogram, malignancy, schizophrenia, neurological disease, auto-immune condition (e.g. rheumatoid arthritis, inflammatory bowel disease, multiple sclerosis, lupus), chronic infection (e.g. human immunodeficiency virus, hepatitis B or C), and hematologic, renal or hepatic abnormality. 6. Subjects will be excluded for a positive anti-double stranded DNA antibody test | 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 Meet diagnostic for current Major Depressive Disorder Men or women aged 18-65 Medication-free for one week prior to the start of the study Agrees to use an effective form of contraception throughout the study Anyone who is suicidal Pregnant or breastfeeding women Anyone with a serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease Anyone with a history of seizure disorder or hypothyroidism Anyone with a history of psychiatric disorders including bipolar disorder, schizophrenia, psychoses, or substance abuse (including alcohol abuse active within the last 12 months) Anyone with a history of intolerance or multiple adverse drug reactions or allergy to (es)citalopram Patients who are currently taking medications active on GABA, including benzodiazepines | 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): 5.0-17.0, Autism Child/Teen has autism He/She is between five and seventeen years of age He/She is not in the hospital He/She has a parent or legal guardian who is willing and able to sign the informed consent Child/Teen has been diagnosed with a psychotic disorder (such as schizophrenia) or a mood disorder, including depression or bipolar disorder (manic depression) He/She has caused visible harm to him/herself or is at risk for suicide He/She has an active seizure disorder or epilepsy (seizures within the past year) He/She has an unstable medical illness, including heart disease He/She has experienced brain injury He/She has a history of diabetes He/She has a history of prior treatment with Omega 3 Fatty Acids He/She lives in a far away area and/or does not have regular access to transportation to the clinical facility A pregnant female or unwilling to use acceptable contraception if sexually active | 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, Oropharyngeal Cancer Head and Neck Cancer Stage I-IV 2. At least 18 years of age 3. Speak and read English at a 7th grade level 4. Are oriented to time, person, and place 5. Have a Zubrod performance status of 0-3. 6. To be eligible for the pilot depression intervention patients must score 9 or above on the Patient Health Questionnaire (PHQ-9). Additionally, if a patient has an elevated PHQ score and does not meet the cutoff but expresses a desire to be in the intervention in order to relieve his or her depression, then the PI will contact the participant to further assess for the intervention. Patients who do not make the cut-off will still be included in the study's statistical analyses Do not have other cancer diagnoses, excepting non-melanoma skin cancer | 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): 18.0-55.0, Major Depressive Disorder Diagnosed with recurrent major depressive disorder Patients with treatment resistance for depression History of alcohol abuse/dependence, substance abuse/dependence within 6 months Has clinically significant unstable medical condition Has significant risk of suicide | 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, Melanoma Survivors Psychological Factors For the focus group recruitment (Specific Aim 1) Patients with melanoma (invasive primary cutaneous melanoma, stages 1-III), who have been treated at MSKCC from 1996-2005 For the survey group recruitment (Specific Aim 2): patients with melanoma (invasive primary cutaneous melanoma, stages 1-III), who have been treated at MSKCC from 2001-2011• Ability to sign informed consent which indicates the psychosocial, behavioral, epidemiological nature of this study • Age ≥ or = to 18 years and fluent in the English language Patients with intraepithelial (in situ) melanoma Patients with stage IV melanoma Patients with nodal or visceral melanoma without a documented primary lesion Patients with prior malignancies For the focus group recruitment (Specific Aim 1): (patients treated at MSKCC from 1996-2005) who have a diagnosis >10 years ago from treatment. For the survey group recruitment (Specific Aim 2): patients treated at MSKCC from 2001-2011)who have a diagnosis >10 years ago from treatment Patients with a recent diagnosis of melanoma, <12 months Patients who are one year or more post diagnosis and are still receiving treatment for their melanoma | 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 Male or female outpatients Aged 18-65 who meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition, Text Revision (DSM-IV-TR) diagnostic for Major Depressive Disorder (MDD) Have a Montgomery-Asberg Depression Rating Scale (MADRS) total score of at least 22 at visits 1 and 2 Have a Clinical Global Impressions of Severity Scale (CGI-S) score of at least 4 at visits 1 and 2 Have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator Patients judged clinically to be at serious suicidal risk in the opinion of the investigator Patients who have any prior history of bipolar disorder, psychosis, or schizophrenia Patients who have any current (within the past six months) DSM-IV-TR primary Axis I disorder other than MDD Patients with uncontrolled narrow-angle glaucoma Patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of 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): 18.0-70.0, Major Depression Current MDD or MDD within the past year or current dysthymia PHQ-9 > 10 have been prescribed an antidepressant medication (by their PCP) at least 8 weeks before pre-treatment timepoint are able to speak, read, and understand English sufficiently well to complete study procedures are between the ages of 18 and 70 presence of significant suicidal ideation or risk history of bipolar disorder, schizophrenia, psychotic symptoms, or severe alcohol or drug problems within the past year history of antisocial personality disorder or borderline personality disorder currently in psychotherapy or have received counseling more frequently than once per month in the past year | 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): 0.0-999.0, Depression Patients meeting for a diagnosis of major depression, single or recurrent episode as described by the DSM-IV manual (appendix 1) A HAM-D 17 total score of at least 16 at baseline (DSM-IV manual, appendix 2) Patients above 18 years of age who meet the requirements Patients taking MAOI's within 2 weeks prior to the survey Patients known to be suffering from bipolar disorder or schizophrenia Patients who are treatment-resistant, i.e., in the past 3 years have failed (a) three previous adequate trials of greater than or equal to 2 classes of antidepressant medication, or (b) electroconvulsive therapy Drug or alcohol dependence or abuse in the past 6 months per DSM IV criteria | 1 |
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