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A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-39.0, Bipolar Disorder No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Positive test for HIV, Hepatitis B, or Hepatitis C Treatment with known enzyme altering drugs History of allergic or adverse response to lithium, or any comparable or similar product | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 25.0-45.0, Bipolar Disorder No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Participation in a clinicl trial within 30 days prior to study initiation Positive test for HIV, Hepatitis B, or Hepatitis C Treatment with known enzyme altering drugs | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-38.0, Bipolar Disorder No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Positive test for HIV, Hepatitis B, or Hepatitis C Treatment with known enzyme altering drugs History of allergic or adverse response to lithium, or any comparable or similar product | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Depression Meets DSM-IV for Axis I bipolar II disorder Meets DSM-IV for Axis I major depressive episode Score of 16 on 17-item HAM-D rating scale Not taking monoamine oxidase inhibitors (MAOI) for more than 2 weeks prior to study entry Willing to use an effective form of birth control throughout the study History of mania Current primary Axis I diagnosis other than bipolar II disorder Alcohol or drug dependence within 3 months prior to study entry Contraindication to treatment with venlafaxine or lithium Unstable medical condition (e.g., thyroid disease, hypertension, or angina pectoris) Pregnant or breastfeeding Experiencing suicidal thoughts Requires hospitalization Requires concurrent neuroleptic or MS therapy Requires concurrent AD therapy | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-35.0, Weight Gain Age 18-35 Body mass index between 23 and 30 Interested in preventing weight gain BMI outside of range specified Age outside of range specified History of or current eating disorder or substance abuse Recent weight loss greater than 5% of weight Currently in another research study that would interfere | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 12.0-35.0, Depression, Bipolar Depressed bipolar patients (N=100; 15-20 patients/year) Patients will meet DSM-IV for type I bipolar disorder, depressed, as determined by structured interview and best-estimate diagnostic procedures.138 Patient has experienced a maximum of three documented affective episodes Patient has been off medications for one week prior to study enrollment Patient has a Hamilton Depression Rating Scale (HDRS) total score ≥20 Patient is between the ages of 12 and 35 years All subjects will be excluded from participation for the following reasons Any chemical use disorder within 3 months Any history of significant suicidality that would place the patient at risk to participate in this protocol Current score ≥3 on item 3 of the HDRS-17 (Suicide Item) Any medical or neurological disorder that could influence fMRI results A history of mental retardation or an estimated IQ total score <85 An MRI scan is contraindicated in the subject for any reason The patient lives >100 miles from the University of Cincinnati or cannot attend follow-up visits Meets DSM-IV for a bipolar mixed episode | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-64.0, Sleep Initiation and Maintenance Disorders Diagnosis of primary insomnia based on Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Depression DSM-IV diagnosis of major depressive disorder (MDD) Drug naive from prior psychotropic medication for more than 6 months before study entry Hamilton-Depression (HAM-D) 17 score greater than or equal to 16 Woman of childbearing age with a negative pregnancy test within 48 hours of scanning DSM-IV Axis I diagnosis other than MDD Use of psychotropic medication within 6 months of study entry History of bipolar disorder Current alcohol or drug abuse/dependence within 6 months of study entry History of sensitivity or intolerance to s-citalopram Medical contraindication to the use of s-citalopram Unstable medical condition (e.g., angina pectoris, untreated hypertension) Pregnant or nursing Woman of childbearing potential not using a medically acceptable form of birth control Actively suicidal or requiring hospitalization | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Healthy Therapeutic Equivalency Sex: Male or Female; similar proportions of each preferred Age: At least 18 years Weight: must be 15% of ideal weight for height and frame Subjects must be in good health and physical condition as determined by medical history Subjects must read and sign the Consent Form history of treatment for alcoholism, substance abuse, or drug abuse within past 24 months history of malignancy, stroke, diabetes, cardiac, renal or liver disease history of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease history of treatment for asthma within the past five (5) years history of mental depression, pulmonary disease, sleep apnea females who are pregnant or lactating history of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative conditions upon screening which might contraindicate or require that caution be used in the administration of zolpidem tartrate, including sitting systolic blood pressure below 90 mm Hg, or diastolic pressure below 50 mm Hg; heart rate less than 50 beats per minute after a 5-minute rest in a seated position inability to read and/or sign the consent form treatment with any other investigation drug during the four (4) weeks prior to the initial dosing for this study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 21.0-55.0, Primary Insomnia Patients with insomnia will meet RDC for psychophysiologic insomnia(99). These are provided in Appendix 2. In addition, the complaint of disturbed sleep will have one or more of the following characteristics > 30 minutes to fall asleep (Initial Insomnia) awakenings per night of >15 minutes duration and/or wake after sleep onset time of > 30 minutes (Middle Insomnia) An awakening of > 30 minutes prior to the desired "wake up" time (Late Insomnia) Any two of the above complaints (Mixed Insomnia) Additionally, total sleep time will not exceed 6 hours (unless the sleep efficiency quotient is < 80%) and the problem frequency must be equal to or greater than 4 nights/ week (severe insomnia) with a problem duration > 6 months (chronic insomnia). This profile must be evident at both intake (based on retrospective reports) and as an average profile from the two weeks of baseline diaries (based on prospective sampling) Unstable medical or psychiatric illness Assessed with the Mini International Neuropsychiatric Interview (MINI) and the The Schedule for Affective Disorders and Schizophrenia-Lifetime Version (SADS-L) To assure that the insomnia is not secondary to these factors Symptoms suggestive of sleep disorders other than insomnia Assessed with the SDS-CL To assure that the insomnia is not secondary to these factors Polysomnographic data indicating sleep disorders other than insomnia Assessed with PSG in collaboration with our sleep medicine consultants To assure that the insomnia is not secondary to these factors History of head injury with a sustained loss of consciousness Assessed by self report during the Intake Interview To help assure that the EEG measures are unconfounded by brain damage Evidence of active illicit substance use or fitting for alcohol abuse or dependence Assessed with a structured psychiatric interview schedule (the MINI) , written versions of clinical interview queries regarding alcohol use, abuse and dependence (the AUDIT and CAGE), the toxicology screen which is part of the clinical chemistries obtained during the screening physical. To assure that the insomnia is not secondary to these factors and to assure that substance use/abuse does not confound treatment Use of CNS active medications, antidepressants, and hypnotics other than zolpidem Assessed by self report and from the toxicology screen which is part of the clinical chemistries obtained during the screening physical. To help assure that the clinical effects observed in this study are due to the study medication and schedule of reinforcement Inadequate language comprehension Informally, assessed by the Clinical Research Coordinator during Intake Interview To assure the quality of self report data as all the measures are in English Pregnancy Assessed by self report and from the clinical chemistries data obtained during the screening physical. Excluded so as to 1) prevent the fetus from exposure to the study medication (although it should be noted that the medication is considered FDA pregnancy category B) and 2) control for the biopsychosocial changes that occur with pregnancy and may alter the response to the study medication and schedule of reinforcement No first-degree relatives with bipolar disorder or schizophrenia Assessed by self report and a structured psychiatric interview schedule (the SADs). Excluded to reduce risk for first onset during the study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Mania Key Clinical diagnosis of bipolar I disorder mania, manic or mixed episode, with or without psychotic features Current ongoing lithium or valproate treatment with the possibility of benefiting, based on the investigator's clinical judgment, from adjunctive treatment with aripiprazole Therapeutic serum levels of lithium or valproate and a Young Mania Rating Total Score of 16 or higher at screening and baseline Participants taking current lithium or valproate treatment combined with antipsychotic medication other than aripiprazole are acceptable, provided that the other antipsychotic medication is washed out at least 3 days prior to the blood draw for therapeutic plasma levels of lithium and valproate determination. Long-acting antipsychotics must be washed out prior to entering the double-blind treatment Key Women of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 4 weeks after the last dose of investigational product A diagnosis of delirium, dementia, amnesia or other cognitive disorder, or a psychotic disorder Current diagnosis of delirium, dementia, a cognitive disorder (ie, amnesia), or a psychotic disorder (ie, schizophrenia or schizoaffective disorder) Current diagnosis of bipolar II disorder, bipolar disorder not otherwise specified, or any other primary psychiatric disorder other than bipolar I disorder mania Thyroid pathology Demonstrated cocaine abuse or dependence within the past 3 months prior to screening History of neuroleptic malignant syndrome from antipsychotic agents Manic symptoms that investigator considers refractory to treatment Previous nonresponsive (by investigator judgment) to aripiprazole for manic symptoms Significant risk of suicide based on history, mental status exam, or investigator judgment | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-60.0, Acute Mania in Bipolar Disorder Provision of written informed consent before initiation of any study related procedures. Patients who are deemed incapable of providing informed consent maybe enrolled if written informed consent has been obtained from the patient's Legally Authorized Representative Documented clinical diagnosis meeting the DSM-IV for any of the following 4X Bipolar I Disorder, Most Recent Episode Manic 0X Bipolar I Disorder, Single Manic Episode Have a YMRS score of at least 20 and a score of at least 4 on 2 of the following 4 YMRS items both at enrolment and at randomisation: Irritability, Speech, Content, and Disruptive/Aggressive Behaviour Female patients of childbearing potential must have a negative urine pregnancy test at enrolment and be willing to use a reliable method of birth control, i.e., barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive, intrauterine device, or tubal ligation, during the study Be able to understand and comply with the requirements of the study, as judged by the investigator Manic episode judged to be either the direct physiological consequence of a treatment or medical condition other than Bipolar disorder the direct physiological effect of a substance of abuse; intoxication with hallucinogens, inhalants, opioids, or phencyclidine and related substances the direct physiological effect of psychostimulant or antidepressant medication Evidence of clinically severe or active disease, or a clinical finding that is unstable or that, in the opinion of the investigator, would be negatively affected by the study medication or that would affect the study medication History of seizure disorder, except febrile convulsions Hospitalization period of 3 weeks or longer immediately prior to randomization for the index manic episode Known history of intolerance or hypersensitivity to quetiapine or lithium, or to any other component in the tablets/capsules Known lack of response to quetiapine or lithium, as judged by the investigator Use of antipsychotic medication or mood stabilizer other than quetiapine and lithium at the day of randomisation (to be tapered to discontinuation between the enrolment visit and randomisation) | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Healthy Sex: Male or Female; similar proportions of each preferred Age: At least 18 years Weight: must be 15% of ideal weight for height and frame Subjects must be in good health and physical condition as determined by medical history Subjects must read and sign the Consent Form History of treatment for alcoholism, substance abuse, or drug abuse within past 24 months History of malignancy, stroke, diabetes, cardiac, renal or liver disease, or other serious illness History of GERD, malabsorption syndrome, colon cancer, or chronic colitis, including Crohn's disease History of treatment for asthma within the past five (5) years History of mental depression History of pulmonary disease History of sleep apnea Females who are pregnant or lactating History of hypersensitivity to zolpidem tartrate, or any hypnotic or sedative Treatment with any other investigational drug during the four weeks prior to the initial dosing of the study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 12.0-39.0, Schizophrenia Schizoaffective Disorder Schizophreniform; Bipolar I Disorder Bipolar II Bipolar NOS Psychotic Disorder Not Otherwise Specified Autism Children and adolescents ages 12-18 with a diagnosis of Schizophrenia, Schizoaffective Disorder, Schizophreniform, Bipolar I, Bipolar II, Bipolar NOS or Psychotic Disorder NOS Subjects must be on either Olanzapine, Seroquel, Clozapine or Risperdal for less than 6 weeks and have gained at least 2% of the body weight during that time Subjects who have diabetes, hyper or hypothyroidism or other metabolic abnormalities Females who are pregnant or breast-feeding Diagnosis of asthma or peptic ulcer disease Antihypertensive agents, Metformin, lipid-lowering agents, thyroid r replacement therapy | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-55.0, Methodology Study Age 18-55 BMI 18-30 kg/m2 body weight > 50 kg no history of sleep disorder no concurrent medications no alcohol use no medical issues no smoking | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-45.0, Bipolar Disorder Medically healthy Meets DSM-IV for bipolar disorder of any subtype No more than 32 weeks gestation, dated by last menstrual period Active suicidality or homicidality Acute psychotic symptoms | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar I Disorder Male and female adult patients with bipolar 1 disorder and acute agitation Agitation caused primarily by acute intoxication History of drug or alcohol dependence Treatment with benzodiazepines or other hypnotics within 4 hours prior to study drug administration | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Age 18-65 male or female DSM -IV for bipolar I affective disorder Ability and willingness to sign informed consent for participation in the study Unwillingness or inability to participate in the study | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-60.0, Spinal Cord Injury Subjects of either gender and 18-60 years of age Subjects with chromic spinal cord injury (defined as a history of spinal cord injury for 12 months or longer) Subjects with ASIA classification of A, B, or C for at least 6 months unchanged Spinal cord injury vertebral level should be between C4 and T10 Subjects must be able to read, understand, and complete the VAS Subjects who have voluntarily signed and dated an informed consent form, approved by an IRB/IEC, prior to any study specific procedures A history of hypersensitivity or other adverse reaction to lithium Significant renal, cardiovascular, hepatic and psychiatric disease Significant medical diseases or infection Addison's disease Debilitation or dehydration Recently taken or are taking diuretics or other drugs with known interaction with lithium, such as tricyclic antidepressants, NSAIDs and tetracyclines A history of alcohol abuse or drug abuse Pregnant or lactating women Female of childbearing potential and are unwilling to use an effective contraceptive method while enrolled in the study Subjects who are currently participating in another investigational study or has been taking any investigational drug within the last 4 weeks prior to screening of this study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-35.0, Healthy Healthy Males age 18 to 35 inclusive Body Mass Index 18 to 30 Willing to adhere to prohibitions and restrictions specified in protocol Must give informed consent Clinically significant abnormal lab values for chemistry, hematology or urinalysis at screening Clinically significant abnormal physical exam, vital signs, or 12-lead EKG at screening Significant history of or current significant medical illness Significant history of or current psychiatric or neurological illness or sleep apnea Participation in another research study involving exposure to ionizing radiation within the last 12 months Any clinically significant MR abnormality which may be relevant to the study Metal implants which are relevant for MR or PET procedures or data History of epilepsy or fits or unexplained blackouts Serology positive for Hepatitis B surface antigen, Hepatitis C antibodies, or HIV antibodies Positive urine screen for drugs of abuse | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 8.0-19.0, Psychotic Disorders DSM diagnoses that have an FDA indication for atypical antipsychotic use for at least one agent in the respective pediatric or adult age group. Specifically, primary DSM-IV diagnosis of Early Onset Schizophrenia Spectrum (EOSS; schizophrenia, schizoaffective disorder, schizophreniform disorder, psychotic disorder NOS); Bipolar Spectrum (bipolar I, II and NOS); Major depressive disorder with psychosis; Mood disorder NOS corresponding to Leibenluft and colleagues severely mood dysregulated (SMD) broad spectrum bipolar disorder; Mood disorder NOS corresponding to irritability associated with autism spectrum disorders; or for adult teen participants aged 18-19 years Major depressive disorder. Diagnoses will be determined by clinical interview, Leibenluft's modification of the K-SADS-PL, and the "Aberrant Behavior Checklist" (cutoff score of 18, as used by FDA for approval of risperidone and aripiprazole in minors) Clinically stable on current treatment regimen for at least 30 days, as assessed in a three-step process Current SGA treatment with olanzapine, quetiapine, risperidone, ziprasidone aripiprazole, asenapine, iloperidone, lurasidone, paliperidone, or olanzapine/fluoxetine for ≥ 8 weeks Stable dose of current SGA and psychotropic co-medications for at least 30 days Body mass index (BMI) at least in the 85th percentile for age and gender Substantial weight gain over the previous 3 years while taking a SGA, as reflected by family and referring physician's judgment. The weight gain did not have to occur on the child's current SGA. Weight needs to have remained stable or increased over past year Agrees to use two effective forms of birth control or to remain abstinent Has a primary caretaker who has known the child well for at least 6 months before study entry Treatment with any medication (other than the currently prescribed psychotropic medications) that would significantly alter glucose, insulin, or lipid levels. Exception: orlistat and amantadine are permitted if the individual has taken the drug for at least one year without weight loss Major neurological or medical illness that affects weight gain or that would prevent participation in physical activities Fasting glucose levels indicating need for prompt treatment Pediatrician or pediatric gastroenterologist recommendation to address abnormal fasting labs by pursuing more active treatment than those in the 2007 American Medical Association guidelines Diagnosis of anorexia nervosa or bulimia nervosa, as based on current or lifetime DSM-IV Diagnosis of substance dependence disorder (other than tobacco dependence) within the past month, as based on DSM-IV Positive urine toxicology indicating ongoing use of illicit substance Current treatment with more than one antipsychotic medication Current treatment with more than 3 total psychotropic medications (i.e., 2 psychotropics plus SGA), with the exception of subjects taking 2 medications for ADHD in which a total of 4 psychotropic medications are allowed Known hypersensitivity to metformin | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 60.0-999.0, Dementia Alzheimer Disease Dementia, Vascular Sleep Disorders Circadian Dysregulation Age between 60-99 years Clinical diagnosis of Dementia of the Alzheimer's type or Vascular Dementia Subjects who are too agitated to be able to wear the activity monitors Subjects who are actively suicidal or homicidal or for whom the clinical treatment team considers participation in the study to be unsuitable Subjects with untreated primary sleep disorders Subjects who receive any hypnotic medications during their participation in the study; Subjects who received hypnotic medications in normal doses prior to Partners Human Subjects Research Application Form Filename: Protocol Summary Version Date: June 1, 2005 5 enrollment may participate in the study if they agree to stop receiving hypnotic medications (see above) Subjects who are receiving over the counter sleep aids Subjects who can not commit to abstaining from alcohol use while in the study Subjects with any liver disease Subjects with known anaphylactic reaction or angioedema with Zolpidem CR | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 21.0-55.0, Generalized Anxiety Disease Healthy males and/or females Age from 21 to 55 (inclusive) BMI ranges from 18 to 30 kg/m2 Previous participation in a PD 332334 study Pregnant or nursing females Hypersensitivity (allergic) to lithium, Neurontin (gabapentin), or Lyrica (pregabalin) | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Acute Schizophrenia Provision of written informed consent by both patient and legal representative A diagnosis of schizophrenia by Chinese Classification and Diagnostic of Mental Disorder, 3rd version (CCMD-3) Male or female, aged 18 to 65 years MOAS total score ³ 10 at both screening and randomization Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment Able to understand and comply with the requirements of the study Pregnancy or lactation Any CCMD-3 not defined in the Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others Known intolerance or lack of response to quetiapine fumarate or haloperidol, as judged by the investigator Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by CCMD-3 Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by CCMD-3 within 4 weeks prior to enrolment Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-55.0, Weight Gain Subjects must be between the ages of 18 and 55 years old Subjects must have bipolar I disorder, schizophrenia, schizoaffective disorder or MDD as defined by DSM-IV-TR and diagnosed using the Structured Clinical Interview for DSM-IV (SCID) Subjects must have a Young Mania Rating Scale (YMRS) score < 16 and a Montgomery-Asberg Depression Rating Scale (MADRS) score < 24 at screening and baseline visits Subjects must have the Scale for the Assessment of Positive Symptoms (SAPS) scores <2 on all subscales Subjects must have gained > 7% of their body weight following treatment with olanzapine as either documented in their medical records or by patient report Subjects must be obese, as defined by a current Body Mass Index (BMI) > 30 kg/m2 Subjects must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable method(s) of contraception (e.g., hormonal methods, intrauterine device, abstinence) for at least one month prior to study entry and throughout the study Subjects must be on a stable dose of olanzapine for at least 14 days and must have been on 5-30mg/day for at least 1 month Major Subjects with clinically significant suicidal or homicidal ideation Subjects who have a DSM-IV lifetime diagnosis of a substance dependence disorder within the past 6 months or within the past month have been diagnosed with a substance abuse disorder, (except for nicotine abuse or dependence), as determined by psychiatric history or SCID interview Subjects with a clinically significant or unstable medical disease, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, hematologic or other systemic medical conditions, that could interfere with diagnosis, assessment, or treatment of bipolar disorder or obesity, as well as subjects with a history of pancreatitis Patients with clinically significant laboratory abnormalities (> 3 times upper limit of normal), on any of the following tests: CBC with differential, electrolytes, BUN, creatinine, hepatic transaminases, lipid profile, fasting glucose, urinalysis, or thyroid indices or clinically abnormal ECG Female patients who are either pregnant or lactating Any female patient whose sexual activity is unknown or in questions Any history of current or past diabetes that has been treated with pharmacological intervention. Subjects who have a diagnosis of diabetes, are currently receiving exenatide, insulin, or an oral anti-hyperglycemic medication, or who have a nonfasting blood glucose ≥ 200 mg/dl or a fasting blood glucose ≥126 mg/dl on 2 separate tests. Subjects with pre-diabetes will not be excluded Neurological disorders including epilepsy, stroke, or severe head trauma. Mental retardation (IQ <70) Treatment with an injectable depot neuroleptic within less than one dosing interval between depot neuroleptic injections and day 0 Treatment with concurrent mood stabilizers (except lithium), anticonvulsants, or antipsychotics | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorders Metabolic Complication patients with bipolar disorders (I, II, NOS) diagnosed with DSM-IV age between 18 and 65 Decisional capacity is adequate to provide informed consent or has an authorized appropriate surrogate decision maker. in a syndromal remission state at least for 2 months : CGI BP ≤ 3 patients who have exhibited a clinically significant increase in body weight after starting the administration of their current antipsychotic (ie >7% weight gain) diagnosis of eating disorder, substance abuse, and psychotic disorder history of neurological and medical illness pregnant or breast feeding women | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Acute Bipolar Depression Outpatients that meet the diagnostic for bipolar disorder I and bipolar disorder II with the most recent episode depressed The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20 The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12 Patients with a current DSM-IV-TR Axis I disorder other than bipolar disorder within 6 months of enrollment. Patients who pose a current serious suicidal or homicidal risk Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-55.0, Bipolar Disorder Schizophrenia Concurrently taking Zyprexa® for a psychiatric indication such as bipolar disorder or schizophrenia Stable body weight (+ 5%) for at least 2 weeks prior to baseline visit No weight loss program participation within past 3 months Treatment with an atypical Anti-psychotic treatment other than olanzapine with the past 6 months BMI > 40 kg/m2 Use of any dietary supplements related to weight gain or weight loss within past 1 month Use of any medication related to weight or plasma lipid concentration (other than hormonal contraceptives). This includes, but not limited to: antihypertensives, benzodiazepines statins, and psychostimulants Uncontrolled hypertension (SBP >140 or DBP > 90 mmHg) Use of a hypertensive medication Known active alcohol or substance abuse or consumption of > three alcoholic beverages/day Active cardiovascular disease | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Sleep Endometrial Neoplasms Pain be women at least 18 years old have clinical indications of primary endometrioid adenocarcinoma of the endometrium be scheduled for staging surgery by laparotomy under standardized protocols have the ability to communicate in English sufficient for completion of study materials have no neuromuscular/ movement disorders (for actigraphy purposes) have no uncontrolled medical, sleep, endocrine or psychiatric illness (as determined by their attending physician as part of clinical care) have no ongoing use of medication known to affect sleep or wake function (e.g., hypnotics, benzodiazepines, antidepressants, anxiolytics, antipsychotics, decongestants, sedating antihistamines, beta blockers, corticosteroids) have a history of previous or concomitant cancer have an estimated life expectancy of < 6 months will be admitted to the hospital prior to the day of surgery are unable to complete study measures are unable to provide meaningful informed consent | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-64.0, Sleep Initiation and Maintenance Disorders Primary Insomnia Diagnosis of primary insomnia based on DSM-IV (307.42) Written informed consent has been obtained Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week) Patients who are pregnant, lactating or intend to become pregnant during the study period Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial Participation in any clinical trial within 1 month prior to randomization | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-76.0, Cancer Age: 18-76 Current or historical diagnosis of cancer Projected life expectancy of at least one year DSM-IV diagnoses: Acute Stress Disorder, Generalized Anxiety Disorder, Anxiety Disorder due to cancer, Adjustment Disorder with anxious features Any stage of cancer diagnosis Epilepsy Renal disease Diabetes Abnormal liver function Severe cardiovascular disease Malignant Hypertension Baseline blood pressure must be less than or equal to 140/90 Personal history or immediate family members with schizophrenia, bipolar affective disorder, delusional disorder, schizoaffective disorder or other psychotic spectrum illness Current substance use disorder Medication contraindications: anti-seizures medications, insulin, oral hypoglycemics, clonidine, aldomet, cardiovascular medications, anti-psychotics (first and second generation), anti-depressants and mood stabilizers | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-60.0, Bipolar Disorder Patients meeting DSM-IV for either Bipolar I, Bipolar II, Cyclothymic Disorder, or Bipolar Disorder NOS Patients on monotherapy treatment with lithium carbonate at steady state level for a minimum of two weeks prior to study treatment assignment Women are postmenopausal for at least 1 year, or surgically incapable of childbearing, or practicing an acceptable method of birth control (hormonal contraception, intrauterine device, or barrier with spermicide were acceptable) and not pregnant at baseline Patients with a history of an acquired or hereditary neurologic disease, e.g., epilepsy or significant brain trauma Patients on depot medications, including but not limited to haloperidol, decanoate and Depo-Provera Patients who had taken acetazolamide, zonisamide, triamterene, dichlorphenamide, chronic antacids, or calcium supplements, or any medication associated with nephrolithiasis (kidney stone formation) in the month prior to beginning topiramate titration | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Dyssomnias Bipolar disorder patients with sleep disturbance Meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Text Revision (DSM-IV-TR; APA, 2000) diagnostic for bipolar disorder type 1 (established with the SCID: Structured Clinical Interview for DSM-IV) Being inter-episode throughout the experiment as defined by cutoffs widely used in previous research. On the basis that a drug-free group would likely be unfeasible and unrepresentative, participants will not be excluded on the basis of medications prescribed for bipolar disorder. Comorbidity will be allowed as long as bipolar disorder is the primary diagnosis. However, it is necessary to assess comorbidity for reporting purposes Participants who have a history of bipolar 1 or suicidal ideation must be under the care of a psychiatrist Experience distress related to significant sleep disturbance Presence of an active and progressive physical illness (e.g., congestive heart failure, cancer, COPD) or neurological degenerative diseases (e.g., dementia, multiple sclerosis) directly related to the onset and course of insomnia Alcohol or drug abuse (except nicotine) within the past year Active posttraumatic stress disorder Evidence of sleep apnea, restless legs syndrome or periodic limb movements during sleep, or a circadian-based sleep disorder (e.g., delayed or advanced sleep phase syndrome) Patients who pose a current suicidal risk or homicidal risk (assessed by treating psychiatrist) or who have made a suicide attempt within the past 6 months Pharmacotherapy for sleep defined as the benzodiazepine and non-benzodiazepine hypnotics that operate via the GABA A receptor complex and are FDA approved for the treatment of insomnia, selective melatonin agonists, benzodiazepine anxiolytics and over the counter medications with proven efficacy such as melatonin or herbs such as St. Johns wort Use of certain medications known to alter sleep (e.g., steroids, theophylline, propranolol, antihistamines that cause drowsiness) | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-80.0, Multiple System Atrophy Clinical diagnosis of probable MSA (Gilman, et al. 2008) Age ≥18, <80 Heart failure Liver disease Kidney failure Thyroid disease Sick sinus syndrome and/or significant ECG alterations Hyposodemia Treatment with diuretics Treatment with haloperidol and/or other antipsychotics Treatment with NSAIDs or corticosteroids Treatment with ACE inhibitors | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-80.0, SPINOCEREBELLAR ATAXIA 2 Molecular diagnosis of SCA2 (≥34 CAG in the ataxin-2 gene) Age ≥18, <80 SARA score ≥8 SARA score >32 Heart failure Liver disease Kidney failure Thyroid disease Sick sinus syndrome and/or significant ECG alterations Hyposodemia Treatment with diuretics Treatment with haloperidol and/or other antipsychotics Treatment with NSAIDs or corticosteroids | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 20.0-65.0, Sleep Initiation and Maintenance Disorders Patient is diagnosed as a primary insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) Patients complaining of insomnia continuously for 4 weeks or longer Patient's usual bedtime is between 9 p.m. and 12 a.m. for the 4 week period prior to initial screening Patient on most occasions sleeps for a total of ≥3 and <6.5 hours over the 4 week period prior to initial screening Patient's usual wake time after sleep onset in a single night is ≥45 minutes per night for the 4 week period prior to initial screening Patients have a body weight of ≥45 kg and ≤85 kg, a BMI of ≥18.5 and <30 Patients with schizophrenia or manic-depressive psychosis Patients with insomnia caused by physical diseases including chronic obstructive pulmonary disease, bronchial asthma, fibrositis syndrome, chronic fatigue syndrome, rheumatic disease, climacteric disturbance, and dermatitis atopic Patients with circadian rhythm sleep disorder Patient works night shifts Patients with alcoholic sleep disorder Patients with alcohol or drug dependence or a history of these Patients with insomnia related with drugs including antiparkinson, antihypertensive, or steroid drugs Patients with sleep apnea syndrome Patients with restless legs syndrome or periodic limb movement disorder Patients with epileptic insomnia | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 21.0-70.0, Primary Insomnia age 21-70 yrs non-pregnant females who agree to standard birth control for 12 months and males two of the following chronic insomnia complaints: >30 min sleep latency, < 6 hrs sleep, or nonrestorative sleep meet DSM-IV for primary insomnia any acute or unstable illness: conditions making it unsafe for the subject to participate, conditions with a potential to disturb sleep (i.e. acute pain, respiratory infection), and conditions which could interact with the pharmacokinetics or pharmacodynamics of zolpidem chronic illnesses: renal failure, liver disease, seizures, and dementing illnesses current psychiatric diseases: alcohol or substance abuse, depression, and schizophrenia a history of alcohol or substance abuse within the past two years a prestudy positive urine drug screen consuming >14 standard (1oz) alcoholic drinks per week caffeine consumption >300 mg/day smoking during the night (11pm-7am) medications including: anxiolytics, hypnotics. both prescription and OTC, (except in the chronic zolpidem group), antidepressants, anticonvulsants, sedating H1 antihistamines (non-sedating second generation H1 antihistamines are allowed), systemic steroids, respiratory stimulants and decongestants, prescription and OTC stimulants, prescription and OTC diet aids, herbal preparations, and narcotic analgesics. All medications and doses will be documented sleep disordered breathing (SDB) defined as >10 apnea-hypopneas events per hour of sleep time or any other primary sleep (e.g., restless legs syndrome) or circadian disorder | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-90.0, Bipolar Disorder Have a diagnosis of bipolar disorder Be 18 years or older Be a biological parent of a child who is younger than 30 years old Be willing to participate in the survey The participant must be (or must have been) the primary caretaker for his or her child A participant must meet criteria A participant s child cannot have been diagnosed with a mood disorder or other serious psychiatric disorder A participant s child cannot have been adopted The participant s child cannot be 30 years of age or older | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Depression The patient has a diagnosis of bipolar I disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (Text Revision) (DSM-IV-TR) and is currently experiencing a major depressive episode Documentation that the patient has had at least 1 previous manic or mixed episode The patient has had no more than 6 mood episodes in the last year The patient's current major depressive episode must have started no less than 2 weeks and no more than 12 months prior to the screening visit. The current depressive episode must have begun after the patient's current mood stabilizer regime began The patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium, valproic acid, lamotrigine, aripiprazole, olanzapine, risperidone, or ziprasidone (only if taken in combination with lithium or valproic acid) Written informed consent is obtained The patient is a man or woman 18 through 65 years of age The patient is in good health (except for diagnosis of bipolar I disorder) as judged by the investigator, on the basis of medical and psychiatric history, medical examination, electrocardiography (ECG), serum chemistry, hematology, and urinalysis Women of childbearing potential (women who have not reached menopause, women who are less than 2 years postmenopausal, and women who are not surgically sterile) who are sexually active must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the study and for 30 days after participation in the study The patient is willing and able to comply with study restrictions and to attend regularly scheduled clinic visits as specified in this protocol The patient has any Axis I disorder apart from bipolar I disorder that was the primary focus of treatment within 6 months of the screening visit or during the screening period The patient has psychotic symptoms or has had psychosis within 4 weeks of the screening visit or during the screening period The patient has current active suicidal ideation, is at imminent risk of self-harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present The patient has a history of an eating disorder or obsessive compulsive disorder (OCD) within 6 months of the screening visit or during the screening period The patient has a history of alcohol or substance abuse or dependence (with the exception of nicotine dependence) within 3 months of the screening visit or during the screening period The patient has a history of any cutaneous drug reaction or drug hypersensitivity reaction, a history of any clinically significant hypersensitivity reaction, or a history of multiple clinically relevant allergies The patient has any clinically significant uncontrolled medical condition, treated or untreated The patient has received modafinil or armodafinil within the past 5 years, or the patient has a known sensitivity to any ingredients in the study drug tablets The patient has previously participated in a clinical study with armodafinil or has used any investigational product within 90 days of screening. The patient may not enroll in any other clinical study while participating in this study The patient has ever been treated with vagus nerve stimulation (VNS) or deep brain stimulation (DBS), or has been treated with electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 3 months of the screening visit | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Schizophrenia Diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform Females who participate in this study are unable to have children-OR- are willing to remain abstinent from Day -5 until 90 days after discharge Males must be willing to remain sexually abstinent or use an effective method of birth control (e.g. condom) from Day -5 until 90 days after discharge Able and agree to remain off of prior antipsychotic medication for the duration of the study Presence or history (within the last year) of a medical or surgical condition (e.g. gastrointestinal disease) that might interfere with the absorption, metabolism, or excretion of orally administered lurasidone Positive test results within 30 days prior to the start of the study for Participated in another clinical trial or receiving an investigational product within 30 days prior to drug administration Use of concomitant medications that prolong the QT/QTc interval within 14 days prior to Day to follow-up Use of a monoamine oxidase inhibitor within 21 days prior to Day 1 to Restabilization Received depot neuroleptics unless the last injection was at least 1 treatment cycle before Day -5 | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 14.0-45.0, Schizophreniform Disorder Bipolar I Disorder Bipolar II Disorder Major Depressive Disorder With Psychotic Features, Substance-Induced Psychoses Psychosis Not Otherwise Specified Schizophrenia Schizoaffective Disorder Age between 14 and 45 years (inclusive) Male or Female gender DSM-IV-TR diagnosis of Schizophrenia, Schizoaffective disorder,Schizophreniform Disorder, Bipolar Disorder (Type I),Bipolar Disorder (Type II), Major Depressive Disorder With Psychotic Features, Substance-Induced Psychoses, Psychosis Not-Otherwise-Specified (NOS) Outpatient status at the time of randomization Duration of antipsychotic treatment of less than 5 years Ability to provide informed consent Female patients of childbearing potential must be using a medically accepted means of contraception Treatment with olanzapine, clozapine, quetiapine,risperidone or paliperidone for less than 8 weeks duration at enrollment BMI between 18.5 and 30 Inability to give informed consent Currently enrolled in a weight management program Currently being treated with a medication to reduce weight Patients with unstable or active cardiovascular illnesses (myocardial infarction, congestive heart failure, etc), active or end-stage renal disease, and unstable thyroid disease, etc Inclusion/ has been intentionally limited in order to maximize the generalizability of the study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Nicotine Dependence Structured Clinical Interview (SCID) derived DSM-IV diagnoses of Bipolar Disorder (Type I or II), and Nicotine Dependence Young Mania Rating Scale Total Score <12 at study entry HAM-D 17-Item Score >5 and <24 at study entry Fagerstrom Test for Nicotine Dependence (FTND) score of 5 or higher Be able to provide informed consent to participate in this study as judged by clinical evaluation, and scoring at least 80% on a post-consent "test" Smoking at least 10 cigarettes per day (confirmed by an expired breath CO level >10 ppm and a plasma cotinine level >150 ng/ml at baseline) Be motivated to quit smoking within 30 days of initial evaluation, as assessed by a score of 7 or higher on the Contemplation Ladder assessment tool On a stable dose of a mood stabilizer for at least 1 month (e.g. lithium, valproate, carbamazepine, atypical antipsychotic) Judged by the study psychiatrists and/or trained psychiatric clinicians to be in remission from active manic, hypomanic, major depressive and psychotic symptoms based on a clinical interview and SCID-IV ≥1 month prior to study enrollment Meet for current abuse or dependence for any other alcohol or illicit substance within the past 3 months of study enrollment Current evidence by SCID-IV and clinical evaluation of suicidality, homicidality or psychosis Meet DSM-IV for current major depression at the time of baseline evaluation A history of hypersensitivity or other known adverse reactions (e.g. hyperstimulation, severe agitation) to varenicline Serious medical conditions (i.e. a history of severe cardiac, renal or hepatic disease, diabetes mellitus or thyroid abnormalities) EKG abnormalities Prescription of Nicotine Replacement Therapies (NRTs) including patches, gum, lozenges or inhalers Prescription of monoamine oxidase inhibitors (MAO-I's) including selegiline or moclobemide Prescription of varenicline Prescription of bupropion SR | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-40.0, Weight Gain non-smoking, adults < 16 weeks gestation medical comorbidities | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 19.0-65.0, Major Depressive Disorder Suicidality 19-65 years of age Diagnosis of major depressive disorder Currently experiencing suicidal thoughts Depressed patients without suicidality Patients with severe psychotic features or with primary diagnoses of bipolar disorder, schizoaffective disorder, schizophrenia, substance abuse/dependence or generalized anxiety Subjects who have taken lithium or an antipsychotic in the last 2 weeks pregnant women | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-50.0, Sleep Memory to 50 years of age no sleep complaints or problems good sleep quality per questionnaire sufficient time in bed each night any clinically significant unstable medical condition recent psychiatric disorder prior diagnosis or symptoms of a sleep disorder recent history of substance abuse recent use of prescription hypnotic medication or over-the-counter sleep aid recent use of psychotropic medication history of adverse reaction to benzodiazepines body mass index > 36 currently pregnant or nursing currently working rotating or night shift | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 7.0-17.0, Bipolar Disorder Participants aged 7 years to 17 years, 11 months old at time of first dose Participants must meet DSM-IV diagnostic as assessed by a semi-structured assessment (KSADS-PL) and a separate clinical interview with a child/adolescent psychiatrist for manic or mixed episodes in bipolar I disorder Score of > 20 on the YMRS at screening and baseline The participant and legal guardian must understand the nature of the study and be able to comply with protocol requirements. The legal guardian must give written informed consent and the youth, written assent Participants with comorbid conditions [attention deficit hyperactivity disorder (ADHD), conduct disorder], except those listed in Criterion 2, may participate If female: is premenarchal, or is incapable of pregnancy because of a hysterectomy, tubal ligation, or spousal/partner sterility. If sexually active and capable of pregnancy, has been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier) for at least one month prior to study entry and agrees to continue to use one of these for the duration of the study. If sexually abstinent and capable of pregnancy, agrees to continued abstinence or to use of an acceptable method of birth control should sexual activity commence Has a negative quantitative serum ß-human chorionic gonadotrophin hormone pregnancy test at screening and a negative qualitative urine pregnancy test at baseline, if female Participants with a history of substance abuse may participate if they agree to continue to abstain from drugs during the trial and have a negative drug screen at screening or prior to baseline. Those with an initial positive drug screen during screening may have another screen done 1-3 weeks later while in screening, and a negative result will allow the participant to participate The participant is willing and clinically able to wash out of medications during the screening period. Prior to the administration of lithium, participants will have not used any of the following medications: antipsychotics, monoamine oxidase inhibitors, antidepressants within the preceding 2 weeks; stimulants within the preceding week; or fluoxetine or depot antipsychotics in the past month (no stable participants will be asked to discontinue medications) ECG and bloodwork including CBC, electrolytes, etc. (as per Safety assessment procedures listed in Table 6) showing no clinically significant abnormalities Participant who is clinically stable on current medication regimen for bipolar disorder A current or lifetime diagnosis of Schizophrenia or Schizoaffective Disorder, a Pervasive Developmental Disorder (ASQ score > 15), Anorexia Nervosa, Bulimia Nervosa, or Obsessive-Compulsive Disorder Current DSM-IV diagnosis of Substance Dependence Positive drug screen at screening and on retest 1-3 weeks later Participants with symptoms of mania that may be attributable to a general medical condition, or secondary to use of medications (e.g., corticosteroids) Evidence of any serious, unstable neurological illness for which treatment under the auspices of this study would be contraindicated Any serious, unstable medical illness or clinically significant abnormal laboratory assessments that would adversely impact the scientific interpretability or unduly increase the risks of the protocol Current general medical condition including neurological disease, diabetes mellitus, thyroid dysfunction, or renal dysfunction that might be affected adversely by lithium, could influence the efficacy or safety of lithium, or would complicate interpretation of study results Evidence of current serious homicidal/suicidal ideation such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study Evidence of current active hallucinations and delusions such that in the treating physician's opinion it would not be appropriately safe for the participant to participate in this study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Panic Disorder Generalized Anxiety Disorder Subjects must at least age of 18 years of age and not older than 65 Subjects must have lifetime bipolar I, II, or NOS disorder as defined by DSM-IV TR (26) Subjects must have lifetime panic disorder or generalized anxiety disorder (GAD) as defined by DSM-IV (except clause "does not occur exclusively during a mood disorder" of Criterion F for GAD) Subjects' bipolar symptoms must be no more than moderate in severity, defined as a CGI-BP< 4 (27) Subjects' anxiety symptoms must be at least moderate in severity, defined as a CGI-S > 4 (28) Subjects must not be receiving regular mood stabilizing, antidepressant, antipsychotic, or anxiolytic medication for at least one week prior to baseline. Patients receiving fluoxetine or depot antipsychotics should be off these medications for at least four weeks prior to baseline Subjects or their legally authorized representative must sign the Informed Consent Document after the nature of the trial has been fully explained If female, subjects must be: postmenopausal, surgically incapable of childbearing, or practicing medically acceptable effective method(s) of contraception (e.g., hormonal methods, barrier methods, intrauterine device) for at least one month prior to study entry and throughout the study Subjects who do not have lifetime bipolar disorder by DSM-IV-TR (26) Subjects who do not have lifetime panic disorder or generalized anxiety disorder by DSM-IV-TR (26) Subjects who are receiving treatment with an anti-manic or mood stabilizing medication (lithium, valproate, carbamazepine, or an antipsychotic), and in the investigators' judgment, require ongoing treatment with that medication Subjects whose bipolar symptoms are presently more than moderately severe (CGI-BP > 5) (27) Subjects whose anxiety symptoms are presently less than moderately severe (CGI-S < 3) (28) Subjects with clinically significant suicidal or homicidal ideation Subjects with a current DSM-IV TR Axis I diagnosis of delirium, dementia, amnesia, or other cognitive disorders; a DSM-IV TR diagnosis of a substance dependence disorder within the past six months; a lifetime DSM-IV TR psychotic disorder (e.g., schizophrenia or schizoaffective disorder) Subjects with serious general medical illnesses including hepatic, renal, respiratory, cardiovascular, endocrine, neurological, or hematological disease as determined by the clinical judgment of the clinical investigator. Subjects with hypo or hyperthyroidism unless stabilized on thyroid replacement > 3 months Subjects with a clinically significant abnormality in their pre-study physical exam, vital signs, EKG, or laboratory tests | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-64.0, Sleep Initiation and Maintenance Disorders Primary Insomnia Diagnosis of primary insomnia based on DSM-IV (307.42) Written informed consent has been obtained Patients with sleep apnea syndrome, narcolepsy, presence or suspicion of periodic leg movement or restless leg syndrome Patients with hepatic failure, myasthenia gravis, or hypersensitivity to zolpidem Patients who are known to be current drug or alcohol abuser or likely to concomitantly consume alcoholic beverages (more than 3 times/week) Patients who have received antihistamines or antipsychotics will not allow to discontinue the previous medication throughout the study Patients who are pregnant, lactating or intend to become pregnant during the study period Patients who have received antidepressants or anxiolytics will not allow to change the dose or discontinue the previous medication throughout the study Any clinically significant condition, which in the opinion of the investigator makes the patients unsuitable for the trial Participation in any clinical trial within 1 month prior to randomization | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Depression Anxiety Disorders Clinical diagnosis of Major Depressive Disorder or more on MADRS-S Severe depression (more than 35 on MADRS-S or based on interview) Severe psychiatric condition (e.g. psychosis or bipolar disorder) Changed medication during the last three months | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 11.0-17.0, Eating Disorder Male or female between 11 and 17 (less than 18) at beginning of trial Based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV), patient fulfills for diagnosis of Anorexia Nervosa (of which there are two types: restricting or binge-eating/purging) or Eating Disorder Not Otherwise Specified, with a weight of less than or equal to 85% of his or her ideal body weight, as can best be determined at the time of assessment Treated by physician on the eating disorder team at the Children's Hospital of Eastern Ontario (CHEO) Currently receiving treatment with any other antipsychotic medication, mood stabiliser, or stimulant Known diagnosis of: diabetes, impaired glucose tolerance, hyperlipidemia, hepatic dysfunction, substance dependence, narrow angle glaucoma, paralytic ileus, or pancreatitis, or any other medical illness that would be considered to significantly impact treatment or recovery from the eating disorder Any uncontrolled comorbid disease affecting any system including infectious, endocrine, renal, gastroenterologic, respiratory, cardiac, immunologic, or hematologic. Potential participants with controlled comorbidities in these areas may be invited to participate at the discretion of the primary investigator Experienced one or more seizures without clear and resolved etiology Inability to comply with trial requirements including lack of comprehension of English Pregnant or breast-feeding High blood pressure Known allergy or known sensitivity to products in olanzapine Other unspecified reasons that, in the opinion of the investigator, amke the patient unsuitable for enrollment Officially declared incapable of consenting to treatment under the Mental Health Act (Note: If a patient is involuntarily hospitalized, he or she can be invited to participate provided that he or she has not officially been deemed incapable of making treatment decision under the Mental Health Act) | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 30.0-65.0, Multiple Sclerosis Diagnosis of a progressive subtype of multiple sclerosis by revised 2005 McDonald Criteria EDSS of 3.0-6.5 Ages 30-65 Must be mentally capable of providing informed consent and following study guidelines Relapse or steroid treatment within 1 month of trial entry Any current or previous treatment with mitoxantrone, azathioprine, methotrexate, mycophenolate, cyclophosphamide, or any experimental therapy Women who are pregnant, wishing to become pregnant in the coming 30 months, or are breastfeeding Sexually active women unwilling to use reliable contraception (oral contraceptives, condom, IUD) Patients with known kidney dysfunction or creatinine >1.4; known cardiac arrhythmia or significant conduction abnormality on EKG; uncontrolled thyroid disease or TSH >20% above the upper limit of normal; uncontrolled psoriasis, HIV, or any other severe medical condition Patients with a history of unstable psychiatric illness or active severe depression Patients with a history of seizure Concurrent use of any of the following medications: Antipsychotics, diuretics, digoxin, or iodide salts Use of non-steroidal anti-inflammatory drugs (NSAIDs) 5 or more days a week Patients with a history of substance abuse in the past year | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Medication Adherence Bipolar Disorder Diagnosis of Type I or II BD for at least 6 months (confirmed with MINI) On maintenance evidence-based treatment for BD (lithium, antipsychotic, anticonvulsant) Have weight gain concerns that individual believes are related to BD medication treatment Sub-optimal adherence as measured by the Tablet Routines Questionnaire (TRQ) and which the patient feels is related to weight gain concerns. TRQ threshold will be defined as missing an average of 20% or more of all prescribed BD treatment in the last week or month or missing 20% or more of the "offending agent" in the last week or last month. This is consistent with methodologies in PIs previous BD adherence studies Known resistance or intolerance to ziprasidone Medical contraindication to ziprasidone Individuals on ziprasidone immediately prior to study enrollment Prior or current treatment with clozapine Diagnosis of eating disorder Individuals whose sub-optimal adherence is related to inability to pay for BD medication treatment or inability to arrange transportation to BD treatment clinical visits Concurrent medical condition or psychiatric illness, which in the opinion of the research psychiatrist, would interfere with the patient's ability to participate in the trial Current substance dependence High risk of harm to self or others Female who is currently pregnant or breastfeeding | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Depression With Prominent Agitation Male or female Age 18 to 65 Outpatient at enrolment A diagnosis of major depressive disorder Baseline HAMD-17 score > 20 and HAMD Item1 score > 2 both at enrolment and baseline Significant agitation CGI-S score > 4 at screening and baseline Negative serum pregnancy test at enrolment and use of a reliable method of birth control during the study Able to understand and comply with the requirements of the study Able and willing to give meaningful informed written consent Another Axis I diagnosis of primary focus within 6 months of enrolment Axis II disorder causing impact on current diagnosis Current depressive episode <4 weeks, or >12 months Substance or alcohol abuse or dependency as defined by DSM IV within 6 months of enrolment Any pervasive developmental disorder or dementing disorder Treatment with other antipsychotics, mood stabilizer or other psychoactive drugs less than 7 days prior to randomization Treatment with fluoxetine less than 28 days prior to baseline Treatment with MAO inhibitors, anxiolytic drugs in excess of 2 mg lorazepam equivalents/day Insufficient response to more than two antidepressants during the index episode prior to study involvement Known lack of antidepressant response to quetiapine at a dose of at least 50 mg/day x 4 weeks | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-40.0, Bipolar Affective Disorders Cyclothymic Disorder Schizoaffective Disorder Major Depressive Disorder Dysthymic Disorder Obsessive-Compulsive Disorder Panic Disorder Posttraumatic Stress Disorder Premenstrual Dysphoric Disorder Social Anxiety Disorder 40 year old female women currently taking Lithium or Sertraline currently pregnant or breastfeeding concurrent use of any form of hormonal birth control, including oral contraceptive pills, Norplant or Depo-provera hepatic or renal disease irregular menstrual cycles | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Fathers Parenting High-risk Child Maltreatment Prevention Male Guardian Child enrolled in partnering Head Start site Mental Health issues that prohibit involvement in group-based prevention study (e.g., psychosis) | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Major Depressive Disorder men or women age of 18 years or older meet for major depressive episode, and have a family history of bipolar disorder or completed suicide subjects not able to give informed consent pregnant or breast-feeding women current panic disorder, post traumatic stress disorder or psychosis subjects with a history of mania or hypomania subjects with active substance abuse or dependence in the last 6 months current depressive episode less than 4 weeks or greater than 12 months in duration adequate trial of lithium or paroxetine (lithium level ≥ 0.6mmols/l; paroxetine 20mgs ≥ 5 weeks) for this episode of depression concurrent use of other antidepressants or augmenting agents for the treatment of depression clinically significant medical illness, in particular renal impairment | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 0.0-999.0, Bipolar Disorder Patients with bipolar disorder Patients treated with lamotrigine tablets for the first time | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Spinal Cord Injury either gender and 18-65 years old acute or subacute traumatic spinal cord injury (defined as SCI resulting from an exteneral non-penetrating cause that occurred within 4 weeks) neurological status of ASIA A neurological level between C5-T11 MRI shows injury site is within 3 vertebral level and necrotic focus, if exist, is less than 1/3 of the spinal cord diameter professional judgment determinate that subjects need a spinal decompression surgery subjects able to complete neurological examination subjects have voluntarily signed and dated an informed consent form penetration SCI such as gun-shoot, knife-cutting or SCI caused by non-traumatic conditions spinal cord lesion exceeds three segments or necrotic focus with diameter larger than 1/3 of the spinal cord severe complications significant medical diseases or infection pregnant or lactating woman, or female of childbearing potential and who is unwilling to use an effective contraceptive method while enrolled in the study unavailability of suitable umbilical cord blood cells contraindication of lithium carbonate and/or spinal decompression surgery subject is currently participating in another study or has been taking any investigational drug within the last 4 weeks prior to screening investigator suggests that the subject would not be suitable to participate this study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Schizophrenia Diagnosis (DSM-IV) of schizophrenia or functional psychosis including schizophreniform and acute psychosis with schizophrenia symptoms Receiving olanzapine treatment for no more than 3 months The dose of olanzapine is stable for at least 2 weeks prior to randomisation (Visit 2) and subject is willing to maintain a stable dose of olanzapine for the duration of the study Evidence of weight gain in the last 3 months attributable to olanzapine, prior to screening (Visit 1). Wherever possible, investigator must other possible causes of weight gain, such as change in exercise, diet, or other illnesses Each subject must have further weight gain attributable to olanzapine, in the baseline period (between Visits 1 and 2) no more than 5 months subsequent to commencement of olanzapine treatment Willing to maintain a stable dose of any concomitant medications, and have been on a stable dose for a minimum of 6 weeks (with the exception of olanzapine) No changes in diet or exercise for 6 weeks prior to screening (Visit 1) and subject agrees to maintain stability, for the duration of the study (in the opinion of the investigator) Subject has Axis I (DSM-IV) diagnosis of schizoaffective disorder Subject has drug induced or toxic psychosis (in the opinion of the investigator) Subject presents with a clinical picture and/ or history that is consistent with delirium, dementia, amnesia or other cognitive disorder; bipolar disorder or major depression Subject has a significant history of anxiety, suicidal ideation or self-harm based on history or routine psychiatric status examination (in the opinion of the investigator) Subject has an unstable thyroid pathology (including hypo or hyperthyroidism), within the past six months (in the opinion of the investigator) Subject has a history of neuroleptic malignant syndrome Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2 month period prior to randomisation (Visit 2) Subject has a clinical diagnosis of diabetes Subject is taking insulin (i.e. they are insulin dependent) or have had insulin within 6 months prior to the screening visit (Visit 1) Any known or suspected history of (in the opinion of the investigator) | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Able to provide informed consent before beginning any study-specific procedures Male and female patients at least 18 years of age Meets Diagnostic and Statistical Manual -IV for BPI, BP II, or National Comorbidity Survey-R for sub-threshold BP with or without symptoms, in need of medication adjustment(s) Willing to be randomized to either Lithium or Quetiapine If a sexually active female of childbearing potential, be using a reliable method of contraception, such as oral contraceptive or long-term injectable or implantable hormonal contraceptive, double-barrier methods (e.g. condom and diaphragm, condom and foam, condom and sponge), intrauterine devices, and tubal ligation Women with reproductive potential must have a negative urine pregnancy test Unwilling to comply with study requirements Patients who have had severe adverse reaction to Lithium or Quetiapine Patients who require inpatient care Drug/alcohol dependence requiring immediate acute detoxification Pregnancy as determined by serum pregnancy test or breastfeeding History of nonresponse to Lithium at doses >900 mg ≥8 wks or to Quetiapine at doses of at least 300 mg/d ≥ 8 week for depression and at least 400-600 mg/d ≥ 4 wks for mania | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 60.0-999.0, Sleep Duration on the First Night After Surgery Total hip or knee replacement in fast-track setup Age 60 years or above ASA class 1-3 Anesthesia within the pas 30 days Daily use of alcohol > 21 units / week Use of anxiolytics or hypnotics within the past 30 days Inability to read and understand Danish Marked reduction of sight or hearing Parkinson's disease or other neurological disaese causing function deficits Inability to cooperate to sleep monitoring allergy to the drug tested | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Insomnia Depression Suicidal Ideation Persons 18-65 years of age Persons with confirmed DSM-IV diagnosis of MDE by SCID Persons with Research Diagnostic diagnosis of insomnia Persons free of all psychotropic medications for one week before baseline assessment, except that prior FLX treatment will require 4 weeks of abstinence, and MAOIs will require 2 weeks of abstinence Persons with Scale for Suicidal Ideation (SSI) scores >3 but <15 OR SSI >15 and C-SSRS Suicidal Ideation Score <3 Persons with Hamilton Rating Scale for Depression (HRSD24) score >20 Persons with Mini Mental State Exam (MMSE) score >24 Persons with Insomnia Severity Index (ISI) score > 7 Persons with habitual sleep latency > or = 30 minutes or wake time in the middle of the night of > or = 30 minutes, and sleep efficiency < 85% Non-English speaking, reading, writing persons Persons who pose imminent danger to self or others Persons with severe Severe suicidal ideation (SSI > 15 AND C-SSRS Suicidal Ideation Score >4) Persons with clinical diagnosis of dementia Persons with active or past diagnosis of alcohol or substance abuse, bipolar disorder, schizophrenia per the SCID Persons who screen positive for moderate-severe sleep apnea (AHI >10) or a prior sleep laboratory-confirmed diagnosis of a primary sleep disorder, such as sleep apnea or periodic limb movement disorder Persons with excessive daytime sleepiness, defined as an Epworth Sleepiness Scale Score >10 Persons with BMI > 50 Persons with a self-reported history of napping > 2 times per week (as these are associated with sleep apnea and periodic limb movement disorder in depressed insomniacs) Persons who might be harmed by exposure to hypnotics, including pregnant women and patients with respiratory conditions | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Bipolar Disorder Insomnia Fulfilling for SCID-1-verified bipolar I or II disorder Euthymic, as defined by Montgomery Åsberg Depression Rating Scale (MADRS) not higher than eleven, and Young Mania Rating scale (YMRS) not higher than five Fulfilling DSM-IV for primary insomnia or insomnia related to another mental disorder, as assessed by the Insomnia Interview Schedule (IIS) Being or having been in a defined affective episode the last month before Hospitalization in the last two months before Working night shifts Sleep apnea Medical conditions incompatible with participation Inability to cooperate in the 3-week initial phase before randomization | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 0.5-85.0, Influenza For adults and old people Healthy adults aged 18-60 years old, and healthy old people aged >60 years Be able to show legal identity card for the sake of recruitment Without vaccination history of seasonal split influenza vaccine in the recent 3 years Not participate in any other clinical trials during the study Not receive any immunosuppressive agents during and one month prior to the study Be able to understand and sign the informed consent Woman： Who breast-feeding or planning to become pregnant during the study Any history of allergic reactions; was allergic to any component of the vaccine, such as eggs or ovalbumin Any history of severe adverse reactions to vaccines, such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain Autoimmune disease or immunodeficiency Acute episode of chronic diseases or conditions, including chronic hepatitis, hypertension, diabetes mellitus and cardiovascular diseases Guillain-Barre Syndrome Women subjects with positive urinary pregnancy test Any history of immunosuppressive medications or cytotoxic medications or inhaled corticosteroids within the past six months (with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis) Axillary temperature >37.0 centigrade at the time of dosing Psychiatric condition that precludes compliance with the protocol; past or present psychoses; past or present bipolar disorder requiring therapy that has not been well controlled on medication for the past two years; disorder requiring lithium; or suicidal ideation occurring within five years prior to enrollment | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Insomnia Hypersomnia Sleep Problems Men and women age 18-65 DSM-IV diagnosis of bipolar I or II disorder HAM-D-17 score < 17 (i.e. low or no depressive symptoms) YMRS score < 8 (i.e. no or low manic symptoms) Optimized, stable maintenance pharmacotherapy at maximum tolerated dosages in accordance with the revised Texas Implementation of Medication Algorithm DSM-IV insomnia A and B are met (i.e. difficulty initiating or maintaining sleep, for at least 1 month) as operationally defined by Insomnia Severity Index score of > 15 (moderate clinical insomnia) M1 derived average actigraphic total sleep time < 6 hours, and < 40% average total sleep time in high frequency coupling, as measured with the M1 device over 5 days pre-randomization, corresponding to < 1SD below the mean of the M1 normative comparison sample of healthy control participants DSM-IV bipolar I disorder subtype rapid cycling DSM-IV manic or mixed episode in the past 2 months DSM-IV major depressive episode in the past 2 months Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm Pregnancy Medical illness or non-psychiatric medical treatment that is the likely cause of the sleep disturbance or interferes with study participation Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion) Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for > 1 year; past or current substance dependence (including alcohol), schizophrenia, delusional disorder, psychotic disorders not otherwise specified Axis I disorder that needs to be the primary focus of treatment (e.g. current DSM-IV anxiety disorder that disrupts sleep) Sleep apnea, restless leg syndrome, or narcolepsy | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 13.0-21.0, Adolescent - Emotional Problem age 13 to 21 experience a moderately elevated level of depressive symptoms on the CES-D scale (score 16-34) may or may not have had a past history of depression, anxiety and/or substance abuse currently diagnosed with depression, schizophrenia, or bipolar affective disorder currently taking antidepressants or psychotropic medication CES-D score equal or higher than 35, or a proved serious medical illness that causes significant disability or dysfunction exhibit significant reading impairment, mental retardation, developmental disabilities serious imminent suicidal risk or other conditions that may require immediate psychiatric hospitalization have extreme, current drug / alcohol abuse (greater than or equal to 2 on the | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Age 18-65 written informed consent meets DSM-IV (by SCID-I/P) for bipolar I disorder, current episode depressed MADRS score of at least 20 (i.e., moderate depression) and no greater than 34 (i.e., severe depression) at screen and baseline visit YMRS score < 12 at screen and baseline visit currently treated with a lithium preparation (carbonate or citrate) at stable dose for at least 4 wks with level >0.6 and <1.0; and/or valproate at stable dose for at least 4 wks at level >60 and <110; and/or other atypical antipsychotic at stable dose for at least 4 weeks (at least minimum FDA-labeled dose) Caucasian by self-report please see discussion below Psychotic features in the current episode, as assessed by YMRS item #8 > 6 [where treatment guidelines urge use of antipsychotics that may confound isradipine results] felt by the study clinician to require inpatient hospitalization for adequate management (to serious suicide or homicide risk, as assessed by evaluating clinician) or more failed pharmacologic interventions in the current major depressive episode, excluding lithium/valproate/other atypical antipsychotic [response rates for these subjects is likely to be extremely low and would require a substantially larger-scale study to identify treatment effects] obsessive-compulsive disorder, or any diagnosis of a DSM-IV anxiety disorder where the anxiety disorder and not bipolar disorder is the primary focus of clinical attention current substance use disorder other than nicotine, by SCID-I/P a primary clinical diagnosis of a personality disorder, or comorbid diagnosis of antisocial or borderline personality disorder pregnant women or women of child bearing potential who are not using a medically accepted means of contraception (to oral contraceptive or implant, condom, diaphragm, spermicide, intrauterine device, tubal ligation, or partner with vasectomy) women who are breastfeeding other unstable medical illness including cardiovascular, hepatic, renal, respiratory, endocrine, neurological, or hematological disease, based on review of medical history, physical examination, and screening laboratory tests (this will any clinical or laboratory evidence of hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before Visit 1) history of hypertension or current treatment for hypertension | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 17.0-40.0, Primary Insomnia Secondary Insomnia primary insomnia secondary insomnia requiring sleep medication (Zolpidem) for a three-week trial active duty military service member stationed at Fort Carson secondary insomnia to a likely medical condition, such as sleep apnea, chronic obstructive pulmonary disease, restless leg syndrome, and other sleep disorders, which are not appropriately treatable with sleep medication treated for sleep problems using sleep medications which Lunesta, Ambien, Ambien Controlled Release (CR), Seroquel, Trazodone or Remeron major psychopathology (i.e., schizophrenia) severe depression within the past 90 days suicidal ideation within the past 90 days psychiatrically hospitalized within the past 90 days uncontrolled hypertension or diabetes pregnancy previous use of Zolpidem proved to be ineffective or to cause other unwanted side effects actively abusing controlled substances | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Neuropathic Pain Neuralgia Spinal Cord Injuries Age 18 Diagnosis of traumatic spinal cord injury Clinically diagnosed neuropathic pain Pain severity is at least 4 on a 11-point numeric rating scale at screening Pain present regularly for at least 6 weeks before enrollment Able to understand instructions and provide reliable pain assessments Subjects who are voluntarily signed and dated an Ethics Committee approved informed consent form Significant renal, cardiovascular, hepatic, infectious or psychiatric disease Significant brain injury with neurological deficits Debilitation or dehydration Addison's disease Recent (within 1 week) or current use of anti-diuretics or other drugs that interacts with lithium, such as tricyclic antidepressants, nonsteroidal antiinflammatory drug and tetracyclines A history of substance or alcohol abuse within past 1 year A need for elective surgery involving preoperative or postoperative analgesics or anesthetics during the study period Current pregnant or breast feeding, or female who has childbearing potential but is not willing to use an approved method of birth control Participation in any drug study in the last three months History of oral lithium intake for any reason; or | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 10.0-25.0, Bipolar Disorder have at least one biological parent diagnosed as bipolar disorder (bipolar I or II) have at least one of the following syndromes i) two or more DSM-IV defined hypomania/mania symptoms, lasting for at least 4 days; ii) two or more DSM defined major depressive symptoms, lasting for 1 week; iii) at least one of the psychotic symptoms, lasting at least 10 min for each manifestation, and 2-7 manifestations a week for at least 3 months, including: ideas of reference; odd ideas, odd belief, unusual perceptual experiences, bizarre thought or speech, Grandiosity, suspicious ideas, paranoid idea, odd mannerisms, hallucination, disorganized/catatonic behavior; iv)two or more of the DSM-IV defined Attention deficit hyperactivity disorder (ADHD)symptoms; and there must be clear evidence of clinically significant impairment in social, academic, or occupational functioning due to ADHD symptoms DSM-IV defined Axis I disorders Serious general medical illness mental retardation was/is treated with antipsychotic drugs unable to complete neuropsychological tests due to physical conditions in pregnancy and lactation was taking thyroxine therapy in the last three months or is taking hormone therapy | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Anxiety Disorders Men and women age 18-65 DSM-IV diagnosis of bipolar I disorder and at least one of three additional anxiety disorders generalized anxiety disorder, panic disorder, or social phobia HAM-D-17 score <16 (i.e. depressive symptoms) YMRS score < 12 (i.e. no or very low manic symptoms) Current, stabilized (> 3 months) pharmacotherapy treatment under the care of a psychiatrist consisting of optimized, stable maintenance pharmacotherapy at maximum tolerated dosages according to Texas Implementation of Medication Algorithm Active suicidality (HAM-D-17 suicide item #3 score > 3) in the past 2 months. Potential participants scoring 3 or higher on the HAM-D-17 suicide item will be immediately evaluated by the PI and Sponsor and referred to a higher level of care if clinically indicated DSM-IV bipolar I disorder subtype rapid cycling DSM-IV manic or mixed episode in the past 2 months DSM-IV major depressive episode in the past 2 months Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm Current Pregnancy Medical illness or non-psychiatric medical treatment that would likely interfere with study participation Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion) Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for > 1 year; current substance dependence (including alcohol), as assessed by the Structured Clinical Interview for DSM-IV-TR, Substance Use Disorders (Section E); schizophrenia, delusional disorder, psychotic disorders not otherwise specified, obsessive compulsive disorder and posttraumatic stress disorder (due to low prevalence of ~6.5% each) Concurrent psychotherapy other than cognitive-behavioral therapy as provided in this study (to rule out other uncontrolled effects of concurrent psychotherapies) | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder with a diagnosis of bipolar I disorder, manic or mixed phase equal or more than 18 scores in Young Mania Rating Scale (YMRS) Serious general medical illness pregnancy and lactation given long-acting antipsychotic drug within the last two month endocrine disease( e.g.Diabetes and thyrotoxicosis) given thyroxine therapy within the last three months or is being given hormone therapy sexually active and not using contraceptives | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 20.0-64.0, Primary Insomnia Men or women aged between 20 and 64 years Diagnosis of primary insomnia according to defined by DSM-IV Difficulty in maintaining sleep and waking up until 3 am Not having used any psychoactive drug in the last 30 days prior to their in the study Signature of IC Previous history of serious medical illness, neurological or psychiatric disorder Allergy or hypersensitivity to zolpidem Obstructive Sleep Apnea syndrome Polysomnography with apnea and hypopnea index >10/hour or PLM >15/h Other secondary sleep disorders History of substance abuse or dependence History of daily consumption of alcoholic beverages Pregnancy, lactation or refusal to use safe contraceptive methods during the study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 0.0-999.0, Depressive Disorder Bipolar Disorder Suicide Suicide, Attempted Must be a Veteran of the United States Armed Forces Survived an episode of suicidal self-directed violence (including suicide attempts and interrupted attempts) that occurred within three months of admission to the study, or they were admitted within the past three months to a mental health inpatient unit specifically to prevent suicide Have a diagnosis of an affective disorder meeting DSM-IV-TR (2000) for Bipolar I Disorder, Bipolar II Disorder, or current or recurrent Major Depressive Disorder Are able and willing to identify one or more family members, friends, or other contacts and give permission for both clinical providers and the Research Team to contact them if the patient cannot be reached Are able to provide informed consent There is concurrence from the patient's mental health and primary care providers about inclusion/ and confirmation of the providers' willingness to work with the research team in managing the patient during the course of the study Must be registered at a VA Medical Center Schizophrenia or schizoaffective disorder Cognitive impairment defined as a Brief Orientation Memory and Concentration Test score > 10 Lack of decision-making capacity to evaluate the risks versus the benefits of participation as determined by Jeste's brief instrument for assessing decisional capacity, or adjudication of incompetence and the appointment of a guardian or conservator Six or more previous lifetime suicide attempts as ascertained through SPAN, reports from family, or patient self-report Current or recent (within six months) use of lithium History of significant adverse effects of lithium as ascertained through the medical record or self-report Unstable medical conditions or specific medical comorbidity Congestive heart failure by Framingham | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Major Depressive Episode Suicidal Ideation Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation Moderate to severe suicidal ideation 65 years old Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills Able to provide informed consent Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening Unstable medical condition or neurological illness, including baseline hypertension (BP>140/90) or significant history of cardiovascular illness Significant ECG abnormality Pregnancy and/or lactation Current psychotic symptoms Contraindication to any study treatment Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal Inadequate understanding of English Prior ineffective trial of or adverse reaction to ketamine or midazolam Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion Diagnosis of sleep apnea | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 7.0-17.0, Bipolar Disorder Pediatric Bipolar Disorder Childhood-onset Bipolar Disorder 17 years old bipolar disorder type I preferred (at least 1 week of mania) no implanted metal (no braces, no cochlear implants) can not have full Diagnostic and Statistical Manual 4th Edition (DSM-IV) autistic disorder no active drug/alcohol abuse/dependence | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 12.0-18.0, Dialectical Behavior Therapy + Pharmacotherapy Standard of Care Psychotherapy + Pharmacotherapy For the proposed study, are as follows: 1) age 12 years, 0 months to 18 years, 11 months; 2) a diagnosis of Bipolar Disorder (BP) I, II or NOS by the K-SADS-PL with an acute manic, mixed or depressive episode in the 3 months preceding study entry; 3) willing to engage in pharmacotherapy treatment at the CABS specialty clinic; 4) at least one parent or guardian with whom the patient lives or interacts on a significant basis (5 hours per week or more) who is willing to participate in DBT skills training; 5) English language fluency and at minimum a 3rd grade literacy level; 6) able and willing to give informed consent/assent to participate For the proposed study are as follows: 1) evidence of mental retardation, pervasive developmental disorder, or organic central nervous system disorder by the K-SADS-PL, parent report, medical history, or school records; 2) a life-threatening medical condition requiring immediate treatment; 3) current victim of sexual or physical abuse | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Suicide Risk Assessment nurses who work in a variety of wards such as Hematology, Oncology, Stroke and Rehabilitation where potential cases with high suicide risk may be identified | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Suicidal Ideation/Behavior Depression Major depressive episode; inpatient at screening visit; suicidal ideation/behaviour present defined by a clinical rating of 8 on the Sheehan Suicidality Tracking Scale (S-STS) and a rating of ≥20 on the Montgomery Asberg Depression Scale (MADRS) at both screening and baseline visits; both gender, age 18 years Contraindication for and history of lithium treatment within the past 6 months; patient unable to tolerate lithium treatment in the past; comorbid borderline/antisocial personality disorder, currently active substance dependency; patients with acute or unstable severe medical conditions, patients unable to understand the informed consent or involuntary inpatients, positive toxicology screen (illegal drugs), pregnancy and lactation | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 10.0-17.0, Childhood Anxiety Parents With Bipolar Disorder Children at Risk for Bipolar Disorder 17 years old At least one parent with bipolar disorder Meets clinical for a specific anxiety disorder PARS -5 item scale score > 10 at screening and baseline of initial study phase Fluent in English Provision of written informed consent/assent Agrees to participate in 75% of sessions Have any of the Following Documented diagnosis of mental retardation or IQ <70 Previous participation in mindfulness-based treatment Substance use disorder within last 3 months Judged clinically to be suicide risk Concurrent treatment with psychotropic medication (certain exceptions apply, ask for details) Psychotherapy initiated within 2 months prior to screening or plan to initiate psychotherapy during study participation Any lifetime diagnosis of bipolar disorder, cyclothymia, schizophrenia, or other psychotic disorder Any symptom that requires admission to an inpatient psychiatric unit Anxiety symptoms resulting from acute medical illness or acute intoxication or withdrawal from drugs or alcohol | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 2.0-9.0, Parental/Caregiver Anxiety Child's Anxiety Pediatric patients ages 2-9 years ASA class I-II inpatient surgeries of at least 2 hours duration requiring postoperative admission of at least 23 hours contraindication to preoperative sedation, known allergy or sensitivity to the study medications those who lack legal representative consent Patients with weights lying below the 5th percentile or above the 95th percentile according to the current published CDC growth chart will also be excluded regardless of existing specific contraindication | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-60.0, Bipolar Disorder The patient was correctly informed about the study The patient must be insured or beneficiary of a health insurance plan The diagnosis of bipolar disorder is confirmed by the doctor referring the patient to the BEC and confirmed during the preliminary interview at the BEC The patient is euthymic on the day of inclusion. This is supported by a short psychiatric interview conducted at the BEC and the completion of the depression and mania scales (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire) The patient is prescribed a mood stabilizer based on lithium or divalproex The patient is under judicial protection, under tutorship or curatorship The patient formalizes his/her opposition to the studyd It is impossible to correctly inform the patient The patient has mental retardation The patient has practiced substance abuse or dependence within the 6 months prior to study (alcool, cannabis, opiates, psychostimulants) The patient does not meet euthymic (score <= 7 on the HDRS questionnaire and score <= 7 on the YMRS questionnaire) Uninclusion The patients withdraws consent during the study The patient does not understand directions necessary for the neurpsychological tasks The patient is not able to use a computer to complete the neuropsychological tasks | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 13.0-21.0, Bipolar Disorder Suicidal Ideation Diagnosis of Bipolar Disorder I, Bipolar Disorder II, or Bipolar Disorder Not Otherwise Specified Living with or in close contact with at least one parent who is willing to participate Have had at least 1 week in the prior 3 months of significant suicidal ideation and/or at least one suicidal event in the 3 months prior to study intake Willing to be treated pharmacologically by a psychiatrist in the UCLA Child and Adolescent Mood Disorders (CHAMP) clinic Participants requiring immediate hospitalization Diagnosis of borderline personality disorder, schizophrenia, or schizoaffective disorder Current substance dependence disorder | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-69.0, Insomnia age between 18 years to 69 years fluent in German language provide written informed consent ability to understand the explanations and instructions given by the study physician and the investigator Sleep disorders caused by medical factors (e.g. sleep apnea, restless legs syndrome, narcolepsy, substance-induced insomnia) Contraindications to study medication intake according to the information sheet for health professionals (Summary of medicinal Product Characteristics, SmPC; Fachinformation in Germany) assessed by physical examination (including ECG) and medical history allergies to amitriptyline hydrochloride or any of its ingredients allergies to zolpidem or any of its ingredients acute intoxication with alcohol, analgetics, hypnotics or any other psychotropic drug urinary retention delirium untreated closed-angle glaucoma prostatic hyperplasia pyloric stenosis | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 13.0-19.0, Insomnia Depression Between 13-19 years of age Are depressed Have insomnia Are not depressed Do not have insomnia Currently using a sleep aid Have bipolar depression Have psychotic disorder Have a sleep disorder other than insomnia | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Prostate Cancer Ability to understand and the willingness to sign a written informed consent form Subjects with histologically confirmed local adenocarcinoma of the prostate who have elected to proceed with radical prostatectomy as primary curative therapy Subjects having no prior administration of lithium or lithium containing medications within 90 days of study enrollment Subjects >/= 18 years of age ECOG (Eastern Cooperative Oncology Group) performance status of </= 1 Adequate renal function defined as GFR (Glomerular Filtration Rate) >/= 50 mL/min Use of adequate contraception ECG (Electrocardiogram) within normal limits Subjects must agree not to take any new vitamin supplements or herbal remedy during the study period Subjects must be able to safety take lithium carbonate for at least 4 weeks before scheduled prostatectomy Subjects who have received any investigational medication within 30 days of first lithium dose Subjects currently receiving, or who have had previous hormonal, chemotherapy or radiotherapy for prostate cancer Subjects with known brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to lithium carbonate Uncontrolled intercurrent illness such as ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social situations that would limit compliance with study requirements | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 21.0-65.0, Schizophrenia Metabolic Syndrome Vitamin D Deficiency • Men and women with a DSM-IV clinical diagnosis of Schizophrenia, Schizoaffective or Bipolar disorder to 65 years of age; male and female A willingness and ability to provide signed informed consent The subject should have been on quetiapine 100 mg or more for more than 12 weeks Pregnant women Subjects considered at high suicide risk based on the MINI Suicidality Module (> 17 points) Unstable general medical condition or serious illness (e.g. death or hospitalization is anticipated within one year), poor kidney function or liver function (defined as laboratory values ≥ three times the upper limit of the normal), and seizure disorders except for childhood seizure disorders Concurrent therapy with certain psychotropics is permitted, provided that the medication and dose have been stable for the past 90 days Patients on concomitant treatment with clozapine and olanzapine are not permitted Patients on immunosuppressant medications or any orexigenic or anorexigenic drug Patients on concomitant treatment with amphetamines and/ or methylphenidate History of hypothyroidism or thyroxine therapy Patients with a known condition or undergoing therapeutic measures that affects weight, including but not limited to: eating disorder, type I diabetes, hyperthyroidism, thyroxine therapy, Topamax therapy, and infectious diseases, such as HIV, hepatitis B, and hepatitis C Active supplementation of vitamin D within the last 3 months | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder major depressive episode in type2 bipolar disorder or bipolar disorder NOS.(MADRS more than 20 point) ears to 65years subjects who sign the informed consent document don't have Diabetes and abnormal metabolism of sugar not noticed as bipolar disorder have an organic brain disease pregnant or breastfeeding women don't have heart disease have actively suicidal thought(Suicidal ideation score of MADRS is 6) who are judged by the investigator to should be excluded from the study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Bipolar Disorder Suicidal Ideation Depression Meets DSM-IV for BD I and II current depressive episode Able to give written informed consent Age > to 18 years and < 65 years Currently suicidal as defined by a MADRS suicide item score of > 3 or previous history of serious suicidal ideation that required hospitalization All subjects need to have normal hearing and normal/corrected-to-normal vision Medical illness or non-psychiatric medical treatment that would likely interfere with study participation Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion potentially confounding MRI results) Substance abuse within the past 3 months or current substance dependence (confirmed by MINI) Left-handedness Contraindications to MRI (metallic implants, claustrophobia, etc.) Subjects who need urgent psychiatric care requiring hospitalization (evaluated by clinicians) | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 21.0-50.0, Healthy Be in good general health as determined by the investigator Have a 3-month history of a normal nightly sleep pattern based on the subject's self report A usual time in bed A regular bedtime between 2200 and 2400 hours No habitual daytime napping Epworth Sleepiness Scale score ≤ 10 Be able to read, understand, and provide written/dated informed consent before enrolling in the study, and must be willing and able to comply with all study procedures Be able to follow verbal and written instructions provided in English Have a body mass index (BMI) >35 kg/m2 Have symptoms consistent with the diagnosis of any sleep disorder (e.g., insomnia, sleep apnea, narcolepsy, periodic leg movements, or restless leg syndrome) On screening PSG AHI > 10 or PLMAI >10 Have a known or suspected diagnosis of Acquired Immune Deficiency Syndrome (AIDS), or have tested seropositive for human immunodeficiency virus (HIV) antibody or antigen previously Have any clinically significant abnormal finding in physical examination, neurological assessment, vital signs, elevated body temperature, or clinical laboratory tests, as determined by the Investigator Have a known exaggerated pharmacological sensitivity, hypersensitivity, or history of a clinically significant adverse reaction to zolpidem Have a known or exaggerated pharmacological sensitivity, hypersensitivity, or intolerance to doxepin HCl, any tricyclic antidepressant, or antihistamine Currently taking cimetidine or a monoamine oxidase inhibitor (MAOI) Current diagnosis of severe urinary retention Current diagnosis of untreated glaucoma | 1 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-45.0, Diabetes Weight Gain Weight Loss Cardiovascular Disease Obesity Participants will be men of European (self-report of both parents of white European origin) or South Asian (self-report of both parents of Indian, Pakistani, Bangladeshi or Sri Lankan origin) with BMI <25 kg.m-2, who have been weight stable (± 2 kg) for >6 months will diabetes (physician diagnosed or HbA1c ≥6.5% on screening), history of cardiovascular disease, regular participation in vigorous physical activity, current smoking, taking drugs or supplements thought to affect carbohydrate or lipid metabolism, or other significant illness that would prevent full participation in the study | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-70.0, Cirrhosis Age 18 to 70 years Clinical, Biochemical, Radiological ,Histological evidence of cirrhosis of all etiology Child A and B cirrhosis Cirrhosis patients giving h/o persistent sleep disturbances Active alcohol intake or intake within 1 month of enrollment Active substance abuse or intake within 1 month of enrollment Known psychiatric and neurological disorders Patient using antidepressant, anticonvulsants, other hypnotics Pregnancy or lactation Overt hepatic encephalopathy Child C cirrhosis Acute decompensated state of CLD (Chronic Liver Disease) GastroIntestinal bleed, increased jaundice, HE (Hepatic Encepahlopahty) , SBP (Spontaneous Bacterial Peritonitis) HCC (HepatoCellular Carcinoma) with portal vein thrombosis | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-55.0, Bipolar Disorder Age 18 or older If Pregnant, equal to or less than 26 weeks English-speaking DSM-IV Bipolar Disorder, any subtype, Major Depressive Disorder, or Mood Disorder Not Otherwise Specified Able to provide informed consent Daily dosing of lithium Active substance abuse within last 6 months and/or positive urine drug screen Active suicidality No obstetrical care Use of other drugs that affect metabolism of lithium Medications in FDA categories F or X that are not antimanic drugs Chronic Kidney Disease | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Anxiety Depression Bipolar I Disorder Bipolar II Disorder Age 18 or older Experiencing mood disorders (e.g. depression, anxiety, bipolar) defined as a visit with a specified DSM-V code (295.7 Schizoaffective Disorder (Depressive type), 295.7 Schizoaffective Disorder (Bipolar type), 296.41 Bipolar I Current or most recent episode manic Mild, 296.42 Bipolar I Current or most recent episode manic mod, 296.43 Bipolar I Current or most recent episode manic sev, 296.44 Bipolar I Current or most recent episode manic w psychotic, 296.45 Bipolar I Current or most recent episode manic in partial remission, 296.46 Bipolar I Current or most recent episode manic in full remission, 296.40 Bipolar I Current or most recent episode unspecified, 296.40 Bipolar I Current or most recent episode hypomanic, 296.45 Bipolar I Current or most recent episode hypomanic in partial remission, 296.46 Bipolar I Current or most recent episode hypomanic in full remission, 296.40 Bipolar I Current or most recent episode hypomanic unspecified, 296.51Bipolar 1 Current or most recent episode depressed mild, 296.52 Bipolar 1 Current or most recent episode depressed mod, 296.53 Bipolar 1 Current or most recent episode depressed sev, 296.54 Bipolar 1 Current or most recent episode depressed w psychotic, 296.55 Bipolar 1 Current or most recent episode depressed in partial remission, 296.56 Bipolar 1 Current or most recent episode depressed in full remission, 296.50 Bipolar 1 Current or most recent episode depressed unspecified, 296.7 Bipolar 1 current or most recent episode unspecified, 296.89 Bipolar II, 301.13 Cyclothymic, 296.83 Bipolar due to Medical Condition, 296.89 Other Specified Bipolar, 296.80 Unspecified Bipolar, 296.99 Disruptive Mood Dysregulation disorder, 296.21 Major Depressive Disorder Single Episode Mild, 296.22 Major Depressive Disorder Single Episode mod, 296.23 Major Depressive Disorder Single Episode sev, 296.24 Major Depressive Disorder Single Episode w psychotic, 296.25 Major Depressive Disorder Single Episode in partial remission, 296.26 Major Depressive Disorder Single Episode in full remission, 296.20 Major Depressive Disorder Single Episode unspecified, 296.31 Major Depressive Disorder Recurrent Episode mild, 296.32 Major Depressive Disorder Recurrent Episode moderate, 296.33 Major Depressive Disorder Recurrent Episode severe, 296.34 Major Depressive Disorder Recurrent Episode w psychotic, 296.35 Major Depressive Disorder Recurrent Episode in partial remission, 296.36 Major Depressive Disorder Recurrent Episode in full remission, 296.30 unspecified, 300.4 Persistent Depressive Disorder (Dysthymia), 625.4 Premenstrual Dysphoric Disorder, 293.83 Depressive Disorder due to another medical condition, 311 Other specified depressive disorder, 311 Unspecified Depressive disorder, 309.21 Separation anxiety disorder, 300.29 Specific Phobia, 300.23 Social anxiety do, 300.01 Panic Disorder, 300.22 Agoraphobia, 300.02 GAD, 293.84 Anxiety do due to another med condition, 300.09 other specified anxiety do, 300.00 Uspecified Anxiety do, 309.0 Adjustment do with depressed mood, 309.24 Adjustment do with anxiety, 309.28 Adjustment do with mixed, 309.4 Adjustment do with w disturbance of emotions and conduct, 309.9 Adjustment do unspecified, 300.7 Illness anxiety disorder, 293.83 Mood do NOS, 296.9 Mood do unspecified, 291.89 alcohol inducted mood do, 292.84 amphetamine inducted mood do 292.84 cocaine inducted mood do, unspecified inducted mood do, 296.66 episodic mood dis unspecified, 296.64 Severe mixed bipolar do) Possessing a smartphone with either an Android or iOS platform Able to read and write in English Have a designated primary behavioral health care provider who is either using the app with their patients (intervention) or is issuing the surveys on paper in their clinic (control) | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Agitation Male and female patients between the ages of 18-65 years, inclusive Patients (or legal representative) willing and able to provide written Informed Consent Form Psychiatric patients already diagnosed of schizophrenia or bipolar disorder, according to the Diagnostic and Statistical Manual of Mental Disorders IV, Diagnostic and Statistical Manual of Mental Disorders V or International Code of Disease criteria Patients with an on-going agitation episode, or with a previous one within the 6 months prior to screening, attended and managed in the hospital setting Previously treated with with a positive outcome (responders) according to (CGI-I) scale (defined as having a CGI-I score of 1 or 2 at 2 hours after administration of the inhalation) Patients free of active respiratory disease such as acute respiratory signs/symptoms (e.g., wheezing) or with active airways disease (asthma, chronic obstructive pulmonary disease or emphysema) Requirement of family or other caregiver support at study investigator (defined as a patient's relative or caregiver (male or female) ≤ 80 year old, who spend ≥ 3 consecutive hours with patient, with good physical and psychological health status and without physical limitations, reading and writing educational level and able to understand and follow the study procedures) Availability of patient's medical records data about the previous treatment with at hospital setting Patient diagnosed with dementia Patients with serious and unstable illnesses including current hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease and congestive heart failure), endocrinologic, neurologic (including stroke, transient ischemic attack, subarachnoidal bleeding, brain tumor, encephalopathy, and meningitis) Patients with a history of allergic reactions to loxapine or amoxapine Patients who have received an investigational drug within 30 days prior to the current agitation episode must be excluded Patients who are considered by the investigator, for any reason, to be unable to self-administer the inhalation device | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Insomnia Bipolar Disorder Adult outpatients meeting Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) for bipolar I disorder (296.70), bipolar II disorder (296.89), or bipolar disorder not otherwise specified (296.80), with concurrent insomnia related to bipolar disorder (307.42) Currently taking ≥ 1 prescription psychotropic medication (hypnotic agents, anxiolytics, atypical antipsychotics, mood stabilizers, and/or antidepressants) for management of bipolar disorder Subjective total sleep time (sTST) < 6 hours on ≥ 1 night during the prior week Current hypo/manic symptoms, as evidenced by YMRS total score ≥ 12 Current (past 6 months) alcohol or substance use disorder Current psychosis Patients who are actively suicidal or evaluated as being a high suicide risk Women who are currently pregnant or breastfeeding Clinically significant abnormalities on baseline laboratory tests (comprehensive metabolic panel, fasting lipid panel, CBC with differential, thyroid stimulating hormone) Presence of any unstable and/or potentially confounding neurological and/or medical disorder | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-65.0, Major Depressive Disorder Bipolar I Disorder Bipolar II Disorder Bipolar Depression Suicidal Ideation Provision of written informed consent [MDD stream only] Diagnosis of major depressive disorder, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) [BD stream only] Diagnosis of bipolar disorder, type I or type II, currently depressed as determined by DSM-IV diagnostic (confirmed using the MINI) Both females and males, aged 18 to 65 years Inpatient status Female patients of childbearing potential must have a negative urine human chorionic gonadotropin (hCG) test at enrolment and must be taking or willing to take some acceptable form of birth control during the course of the study if they are or plan to be sexually active The ability to understand and comply with the requirements of the study and capable of providing informed consent Suffering from suicidal ideation/attempts as evidenced by a score of >0 on either of the SSI or CSSRS or both Current or past psychotic symptoms Substance or alcohol dependence at enrollment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV within 4 weeks prior to enrollment Any pervasive developmental disorder (according to DSM-IV criteria) Diagnosis of dementia (according to DSM-IV criteria) Known intolerance or hypersensitivity to ketamine or midazolam as judged by the investigator Significant medical condition that would contraindicate the use of ketamine, midazolam or that is untreated and would need urgent attention (as determined by treating physician) Medical conditions that would significantly affect absorption, distribution, metabolism, or excretion of ketamine or midazolam Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator Any clinically significant deviation from the reference range in clinical laboratory test results as judged by the investigator | 0 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-64.0, Depression Alcoholism Drug Abuse African American English speaking Diagnosis of Bipolar Disorder (BD) Able to provide written informed consent Cognitive impairments Acutely psychotic Medically unstable History of schizophrenia spectrum disorder History of mood incongruent psychotic symptoms History of primary substance disorder History of primary organic disease and/or dementia | 2 |
A 26-year-old obese woman with a history of bipolar disorder complains that her recent struggles with her weight and eating have caused her to feel depressed. She states that she has recently had difficulty sleeping and feels excessively anxious and agitated. She also states that she has had thoughts of suicide. She often finds herself fidgety and unable to sit still for extended periods of time. Her family tells her that she is increasingly irritable. Her current medications include lithium carbonate and zolpidem. | eligible ages (years): 18.0-999.0, Healthy Volunteers Male or female study participants, aged above 18 years-old; women cannot be pregnant or breastfeeding Body mass index (BMI) greater than or equal to 19 and less than or equal to 28.75 Kg/m2 Good health conditions or without significant diseases, according to best medical judgement, according to protocol requirements and study evaluations: medical history, blood pressure and heart rate measurements, physical examination, electrocardiogram (ECG) and complementary laboratory tests Ability to understand the nature and objectives of the trial, including risks and adverse events; willingness to cooperate with the researcher and proceed according to all study requirements, which shall be confirmed by Informed Consent Form signature Known hypersensitivity to the investigational product (Zolpidem) or chemically related compounds; history of serious adverse reactions or hypersensitivity to any drug History or presence of hepatic or gastrointestinal diseases, or other condition that interferes with drug absorption, distribution, excretion or metabolism Chronic therapy with any drugs, except oral contraceptives History of hepatic, kidney, lungs, gastrointestinal, epileptic, hematologic or psychiatric disease; hypotension or hypertension, of any etiology, that requires pharmacological treatment; history of myocardial infarction, angina and/or heart failure Electrocardiographic findings that, at investigator are not recommended for study participation Deviations on screening laboratory results that are considered as clinically relevant by the researcher Smoking Intake of more that 5 cups of coffee or tea per day Unusual food habits, e.g., vegetarians History of drugs and alcohol addiction or excessive alcohol consumption (> 35 g/day) | 0 |
A 62-year-old man sees a neurologist for progressive memory loss and jerking movements of the lower extremities. Neurologic examination confirms severe cognitive deficits and memory dysfunction. An electroencephalogram shows generalized periodic sharp waves. Neuroimaging studies show moderately advanced cerebral atrophy. A cortical biopsy shows diffuse vacuolar changes of the gray matter with reactive astrocytosis but no inflammatory infiltration. | eligible ages (years): 18.0-999.0, HIV Infections You may be eligible for this study if you Are HIV-positive Are at least 18 years old Have symptoms of AIDS dementia including forgetfulness, loss of concentration, slow mental processing, or a loss of muscle control Have been on stable anti-HIV drug therapy for the past 6 weeks (if you are taking anti-HIV drugs) You will not be eligible for this study if you Have certain serious medical conditions, such as a mental disorder or an opportunistic (AIDS-related) infection | 1 |
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