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Bipolar Disorder clinical trials

View clinical trials related to Bipolar Disorder.

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NCT ID: NCT00208195 Completed - Bipolar Disorder Clinical Trials

Depakote ER Therapy for Mania Comorbid With Substance Abuse

Start date: March 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to ascertain whether Depakote ER (Divalproex ER) has efficacy in the treatment of patients with bipolar disorder in the manic phase, who also have comorbid substance abuse diagnoses. It is proposed that Depakote ER will decrease scores on the Young Mania Rating Scale and the Substance Abuse Time Line Follow Back.

NCT ID: NCT00208169 Completed - Schizophrenia Clinical Trials

Abilify Therapy for Reducing Comorbid Substance Abuse

Start date: March 2005
Phase: Phase 4
Study type: Interventional

It is hypothesized that the use of aripiprazole (Abilify) in patients with alcohol and/or drug dependence with comorbid psychiatric conditions will lead to: - Reduction in the amount of alcohol and/or drugs used as measured by the Time Line Follow Back (TLFB) and the Addiction Severity Index (ASI) - Reduction in cravings for alcohol and drugs as measured by the Penn Alcohol Craving Scale - Reduction in symptoms of co-morbid psychiatric disorders compared to before starting aripiprazole.

NCT ID: NCT00206778 Completed - Clinical trials for Mixed Mania Bipolar Disorder

Six Month Trial of Lamotrigine vs. Sodium Valproate for Treatment of Mixed Mania

Start date: July 2003
Phase: Phase 2
Study type: Interventional

We are comparing the efficacy of Lamotrigine to that of Standard of Care Sodium Valproate for the treatment of Mixed Mania. The study hypothesis is that Lamotrigine will be more efficative for treating mixed mania in patients with Bipolar Disorder.

NCT ID: NCT00206544 Completed - Bipolar Disorder Clinical Trials

Anti-Estrogens - A Potential Treatment for Bipolar Affective Disorder in Women?

Start date: January 2004
Phase: Phase 2
Study type: Interventional

OBJECTIVE: To test the use of two adjunctive hormonal agents in a 28 day three-arm, double-blind, placebo-controlled study in the treatment of acute mania/hypomania. HYPOTHESIS: That women receiving adjunctive Tamoxifen or Progesterone will demonstrate a more rapid and more substantial decrease in manic symptoms over the course of the study than women receiving adjunctive placebo. STUDY POPULATION: Sixty females with a current diagnosis of Bipolar Affective Disorder or Schizoaffective disorder - Manic Phase, according to the operationalised criteria of the Diagnostic and Statistical Manual, 4th edition (DSM-IV) of the American Psychiatric Association. STUDY MEDICATION: Tamoxifen. One third of patients (twenty) will be randomized to receive adjunctive Tamoxifen at 40 mg/day for 28 days. The Tamoxifen will be administered within a plain capsule to maintain "blinding" of treatment arm. Progesterone. One third of patients (twenty) will be randomized to receive adjunctive oral Provera (progesterone) at 20 mg/day. The Progesterone will be administered within a plain capsule identical to that used with Tamoxifen. Placebo. The remaining one third of patients will be randomized to receive adjunctive placebo (inert substance). The placebo substance will be administered within a plain capsule identical to that used with Tamoxifen and Progesterone. STUDY EVALUATIONS: Data will be collected over a 28-day period for each patient. Visits will be performed at baseline, and then at weekly intervals. A total of five visits will be completed for each patient. The following evaluations will be performed: - Psychiatric evaluation to determine diagnosis. (Baseline visit only) - General clinical evaluation including medical history, current conditions and a non-invasive physical examination, body weight, vital signs. (Baseline visit only) - Medication history (baseline and evaluation visits). - Demographics (baseline visits only). - Completion of clinical rating scales; CARS-M, PANSS, MADRS, AIMS, Barnes Akathisia scale (BA), and Simpson-Angus scale (SA) (baseline and evaluation visits). A Menstrual Cycle Interview and a cognitive assessment (RBANS) will be performed at baseline and endpoint (day 28) visit. - Laboratory tests including; Serum levels of mood stabilizer, luteinizing hormone (LH), follicle-stimulating hormone (FSH), Estrogen, Progesterone, Prolactin, dehydroepiandrosterone (DHEA), Testosterone and protein kinase C(PKC) (baseline and evaluation visits). - Inclusion/exclusion checklist (baseline visit only). - Informed consent (baseline visit only).

NCT ID: NCT00206141 Completed - Depression Clinical Trials

Seroquel in Bipolar Depression Versus Lithium

Start date: August 2005
Phase: Phase 3
Study type: Interventional

This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.

NCT ID: NCT00205933 Completed - Clinical trials for Major Depressive Disorder

Behavioral Processes Underlying Reward Processing in Depression

Start date: April 2004
Phase: N/A
Study type: Observational

The purpose of this project is to use behavioral techniques to investigate emotional processing in subjects with major depression and healthy comparison subjects.

NCT ID: NCT00205699 Completed - Bipolar Disorder Clinical Trials

Metabolic Effects of Antipsychotics in Children

MEAC
Start date: April 2006
Phase: Phase 4
Study type: Interventional

The project aims to describe and compare the outcome of 12 weeks of prospective, randomized treatment with olanzapine, risperidone or aripiprazole on insulin action in skeletal muscle, liver and adipose tissue, abdominal fat mass, total body and fat-free mass, efficacy for symptoms of aggression and non-metabolic adverse events. Children aged 6-18 will be studied, exploring effects of stimulant therapy and age-related differences in vulnerability to treatment-induced adverse metabolic changes. Aims are addressed by measuring glucose and lipid kinetics with stable isotope tracers, body composition with dual energy x-ray absorptiometry and magnetic resonance imaging (MRI), and standardized assessments of efficacy and adverse events. Relevant data are critically needed to target clinical therapy and basic research, identify medical risks, and guide regulatory decisions in this vulnerable population.

NCT ID: NCT00203567 Completed - Bipolar Depression Clinical Trials

Carbamazepine Extended-Release for the Treatment of Bipolar Depression

Start date: August 2005
Phase: Phase 4
Study type: Interventional

To study the efficacy and safety of beaded extended-release Carbamazepine (Equetro) in the treatment of patients with Bipolar Disorder with a Major Depressive Episode.

NCT ID: NCT00203528 Completed - Substance Abuse Clinical Trials

Divalproex ER vs. Risperidone for Bipolar Disorder With Comorbid Substance Use Disorder

Start date: January 2004
Phase: Phase 4
Study type: Interventional

The primary objective is to evaluate the safety and efficacy of divalproex extended release (ER) compared to risperidone in the treatment of bipolar disorder with comorbid substance use disorder

NCT ID: NCT00202306 Completed - Schizophrenia Clinical Trials

Indicated Prevention of Psychotic Disorders With Low-dose Lithium

Start date: November 2001
Phase: Phase 4
Study type: Interventional

This study investigates the neuroprotective properties of low-dose lithium in young individuals at ultra-high risk of developping a first psychotic episode. Fourty individuals having some symptoms of an emerging psychotic disorders (without meeting the threshold for a full-blown mental illness) will be treated with a low dose of lithium (about a third of the dose that is usually used to treat acute mania). We will assess the progression of the conditions of these individuals on a montly bases for a year. We will do behavioural, cognitive and imaging assessments prior start of the treatment, after three months and one year. We hope to demonstrate that low dose lithium will stop or even reverse the progression of disease. We expect that behavioral, cognitive and in vivo brain imaging parameters in those individuals treated with low dose lithium improve, compared to the monitoring group.