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Bipolar Disorder clinical trials

View clinical trials related to Bipolar Disorder.

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NCT ID: NCT01113541 Terminated - Bipolar Disorder Clinical Trials

One-Year Trial of Oral Ziprasidone in Bipolar Patients With Metabolic Syndrome

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

The purpose of this study is to explore the impact of Ziprasidone HCl on the distribution of metabolic syndrome (MS) risk factors in a population of Bipolar patients presenting with glucose intolerance, dyslipidemia and/or elevated waist circumference associated with their current antipsychotic medication.

NCT ID: NCT01093963 Terminated - Bipolar Depression Clinical Trials

Efficacy Study of Lisdexamfetamine to Treat Bipolar Depression

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

The specific aim of this study is to evaluate the efficacy and tolerability of a stimulant (lisdexamfetamine) in the adjunctive treatment of bipolar disorder.

NCT ID: NCT01051440 Terminated - Bipolar Depression Clinical Trials

Magnetic Resonance Imaging Study of Lisdexamfetamine for Bipolar Depression

Start date: February 2010
Phase: Phase 4
Study type: Interventional

There have been reports that stimulants may be effective for bipolar depression without triggering mania. This study will examine whether lisdexamfetamine can improve depressive symptoms over the course of eight weeks. Lisdexamfetamine is a prodrug stimulant that is currently approved for attention deficit hyperactivity disorder (ADHD). Participants take the study drug or placebo in addition to a mood stabilizer. The study includes functional magnetic resonance imaging and magnetic resonance spectroscopy to determine whether the medication alters the response to affective stimuli or glutamate, glutamine, or gamma aminobutyric acid (GABA) levels. Neuropsychological testing is also included to determine whether the study drug improves memory and attention in this population. The primary hypothesis is that lisdexamfetamine is clinically effective in this population. The secondary hypothesis is that it will result in an increased response to affective stimuli and altered neurotransmitter levels in the anterior cingulate cortex.

NCT ID: NCT00947791 Terminated - Bipolar Disorder Clinical Trials

Treatment Study of Bipolar Depression

Start date: July 2009
Phase: N/A
Study type: Interventional

The purpose of this study is to determine whether a single intravenous administration of an N-methyl-D-aspartate antagonist is safe and effective for the acute treatment of bipolar depression.

NCT ID: NCT00939887 Terminated - Depression Clinical Trials

A Study Of Kappa Opioid Receptor Occupancy Of PF-04455242, Using PET (Positron Emission Tomography)

Start date: September 2009
Phase: Phase 1
Study type: Interventional

This is a subject blind, investigator and sponsor open, randomized study consisting of 2 parts. Up to 15 healthy subjects will be included in the study. In the first part of the study the test retest reliability of the radiotracer [11C] PF 04767135 binding in man will be assessed. In the second part of this study, using [11C] PF 04767135, kappa opioid receptor occupancy (RO) will be assessed in up to three cohorts of subjects.

NCT ID: NCT00907985 Terminated - Bipolar Disorder Clinical Trials

A Study to Evaluate the Effect of Single Doses of Drug A (Lamotrigine) and Drug B (Vofopitant) Alone and in Combination on Resting Motor Threshold in Healthy Subjects

Start date: May 15, 2009
Phase: Phase 1
Study type: Interventional

The purpose of this study is to investigate the effect of drug A on its own and when it is given in combination with drug B on markers of brain activity. The study will 1. Assess the effects of drug A and drug B on muscle movement after brain stimulation; 2. Examine how the body handles (absorbs, distributes, breaks down and gets rid of) drug A and drug B when given in combination; 3. Examine the safety of drug A and drug B when given together.

NCT ID: NCT00805493 Terminated - Bipolar Disorder Clinical Trials

Double-Blind Placebo-Controlled Trial of Riluzole in Pediatric Bipolar Disorder

Start date: November 2008
Phase: Phase 2
Study type: Interventional

Pediatric Bipolar Disorder (BD) is uncommon in children. Its symptoms include periods of manic behavior (being overly happy or giddy, feeling grandiose, feeling a decreased need for sleep, having too much energy, moving more than usual, talking fast, having speeded-up thoughts and other symptoms). Sometimes there also is depression (extreme feelings of sadness or irritability, not taking pleasure in things, even ones that used to be enjoyable, feeling worthless or guilty, sleeping too much or having trouble getting to or staying asleep, feeling slowed down or restless, having wishes to be dead or suicidal ideas, and other symptoms). Pediatric BD is often difficult to treat; children may respond only partially to the medications now available or have too many side effects to tolerate them. Riluzole is a medication that is thought to work on a brain chemical called glutamate that may be involved in symptoms of depression and BD. Previous research studies have shown that riluzole may help adults with BD who have depression and adults who have depression, anxiety disorders, or obsessive-compulsive disorders. Riluzole may also be helpful for children with obsessive-compulsive disorder. However, it has never been given to children with BD. This study will evaluate the effectiveness of riluzole in 80 patients between 9 and 17 years of age who have BD and symptoms of anxiety. Participants must have tried at least two other medications that have not been effective. The study will consist of four phases carried out over 4 to 5 months. Most children will be inpatients at the Pediatric Behavioral Health Unit for at least part of the study. In Phase 1, each patient will undergo blood and urine tests, and will gradually taper off his or her medication. The duration of this phase depends on the medication that the patient was receiving before starting the study. In Phase 2, the patient will remain off all medication for 1 week. Throughout this time, patients will be monitored carefully and medication will be restarted if needed. In Phase 3, which lasts 8 weeks, patients will be assigned randomly to receive only riluzole or only a placebo. Those who receive riluzole will have the dose adjusted as needed. Patients and families will be informed of which drug they were on at the end of this phase. Patients who improved on riluzole may continue to receive it from NIH for 1 month and will then be prepared for discharge from the study. Patients who received placebo and improved, and those who received riluzole but did not improve, will be treated with standard medications as appropriate and prepared for discharge from the study. Phase 4 is for patients who received placebo and did not improve. They will be given the chance to try riluzole for 8 weeks and, if it is effective, continue it for an additional 4 weeks while they prepare to be discharged from the study. Patients will not be able to receive riluzole at the National Institutes of Health after the completion of the study. However, the child's doctor may be able to prescribe riluzole as an off-label use. Most patients will be admitted to the Pediatric Behavioral Health Unit at the National Institutes of Health Clinical Center during the medication withdrawal part of the study (Phases 1 and 2). From Phase 3 on, a patient may participate as an inpatient, outpatient, or in day treatment, depending on what is in his or her best interests. All participants in this study will be invited to also enroll in the National Institute of Mental Health protocol 00-M-0198, The Phenomenology and Neurophysiology of Affective Dysregulation In Children And Adolescents With Bipolar Disorder. Some research tests for that protocol will be done during the medication-free period of this protocol.

NCT ID: NCT00771134 Terminated - Bipolar Disorder Clinical Trials

Efficacy and Safety of Lu AA39959 in Patients With Bipolar Depression

Start date: December 2008
Phase: Phase 2
Study type: Interventional

This study will evaluate the efficacy and safety of Lu AA39959 in the treatment of depression in patients with bipolar disorder.

NCT ID: NCT00767715 Terminated - Bipolar Disorder Clinical Trials

A Study in the Treatment of Acute Mania

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

The purpose of this study is to test the efficacy and total costs of olanzapine versus commonly used conventional antipsychotics in Sweden.

NCT ID: NCT00746421 Terminated - Bipolar Disorder Clinical Trials

Quetiapine XR for Cognitive and Functional Disability in Clinically Stable Patients With Bipolar Disorder

Start date: January 2010
Phase: Phase 4
Study type: Interventional

Quetiapine has been reported to have beneficial cognitive effects in several randomized controlled trials in schizophrenia. It has not yet been studied in bipolar disorder, but promising results from the use of extended release quetiapine for the maintenance treatment of bipolar disorder suggests that its cognitive benefits could be detected. Moreover, quetiapine has been shown to have direct beneficial effects on performance-based measures of social competence in schizophrenia and to improve quality of life (QoL) in bipolar depression. The investigators propose to study quetiapine augmentation of mood stabilizer monotherapy in clinically stable patients with bipolar disorder. This will be a randomized, placebo controlled trial, with attentional impairments as the primary outcome and other cognitive performance variables and measures of social and everyday living skills, as well as subjective QoL, as the secondary outcomes.