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Mania clinical trials

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NCT ID: NCT00254488 Completed - Bipolar Disorder Clinical Trials

Treatment of Bipolar Mania in Older Adults

GERI-BD
Start date: November 2005
Phase: Phase 4
Study type: Interventional

This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.

NCT ID: NCT00223236 Completed - Cocaine Dependence Clinical Trials

Trial of Citicoline Therapy in Patients With Mania or Hypomania and Cocaine Abuse/Dependence

Start date: July 2010
Phase: Phase 3
Study type: Interventional

The purpose of this research is to determine if a citicoline supplement is associated with a reduction in cocaine use and craving in patients with bipolar disorder (a mental disorder marked by alternating periods of mania and depression) or schizoaffective disorder/bipolar type (a psychotic disturbance in which there is a mixture of schizophrenic and manic-depressive symptoms) and cocaine abuse/dependence. This research also wants to explore if citicoline supplements are associated with greater improvement in symptoms of mania and on memory and cognition (the mental faculty of perception, reasoning, and judgement) in these patients.

NCT ID: NCT00217165 Completed - Bipolar Disorder Clinical Trials

Taurine as an Anti-Manic Agent: A Double-Blind, Placebo-Controlled Study

Start date: April 2005
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine whether the amino acid taurine has effects on mood stability in bipolar disorder.

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: 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: NCT00181935 Completed - Bipolar Disorder Clinical Trials

Risperidone Versus Olanzapine for Mania in Preschool Children 4 to 6 Years of Age With Bipolar Disorder

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

The objectives of this study are to study the safety, effectiveness, tolerability and dosing regimen of risperidone, and olanzapine, in the treatment of mania in Bipolar Disorder I and Bipolar II Disorder in preschool children over an 8 week period. We hypothesize that these atypical neuroleptics may be effective in treating pediatric mania, with a lower risk of extrapyramidal side effects.

NCT ID: NCT00181922 Completed - Bipolar Disorder Clinical Trials

Ziprasidone for the Treatment of Mania in Children and Adolescents With Bipolar Disorder

Start date: March 2002
Phase: Phase 4
Study type: Interventional

The objective of this study is to compare the safety and effectiveness of Ziprasidone in the treatment of mania in children and adolescents with Bipolar disorder over 8 weeks. This is an exploratory, open-label study, which seeks to determine if there is evidence for efficacy. The results of this study will be used to generate hypotheses for a larger study.

NCT ID: NCT00181883 Completed - Bipolar Disorder Clinical Trials

Quetiapine for Mania In Preschool Children 4 to 6 Years of Age With Bipolar Disorder

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

This is an 8-week open-label study aimed at assessing the effectiveness and tolerability of Quetiapine, in the treatment of preschool children aged 4 to 6 years with bipolar and bipolar spectrum disorder. This is an exploratory, pilot study, seeking to determine whether Quetiapine is efficacious and well tolerated in the treatment of preschoolers with pediatric bipolar and bipolar spectrum disorder in this age group. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial with explicit hypotheses and sufficient statistical power.

NCT ID: NCT00181870 Completed - Bipolar Disorder Clinical Trials

Equetro for the Treatment of Mania in Children Ages 6-12 With Bipolar Disorder

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

This is an open-label pilot study of up to 1200 mg/day of carbamazepine ER (Equetro) in the treatment of children who meet DSM-IV criteria for Bipolar I, Bipolar II, or Bipolar Spectrum Disorder. The main goal of this study is to begin to address the void of information on safety, tolerability and effectiveness of Equetro in the treatment of Pediatric Bipolar Disorder.

NCT ID: NCT00181844 Completed - Bipolar Disorder Clinical Trials

Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder

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

The main objective of this study is to assess the effectiveness and safety of lamotrigine in the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory, 12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study results will be used to generate hypotheses for a larger randomized controlled clinical trial. Based on the available literature in adults with bipolar disorder, we hypothesized that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and bipolar spectrum disorders.