Active clinical trials for "Bipolar Disorder"

Childhood bipolar disorder- not otherwise specified (BP-NOS) was originally considered to be a milder version of bipolar disorder (BD). Research now indicates that BP-NOS is a highly impairing condition. No pharmacologic treatment guidelines exist for BP-NOS. Available evidence-based pharmacotherapy guidelines are for BP1; efficacious medications are, unfortunately, associated with significant risk for adverse events (Kowatch et al, 2005; 2009). Previous research on diet and nutrition suggests that omega-3 (Ω3) fatty acids have a beneficial effect on mood, which might provide either a primary or adjunctive treatment with a more favorable risk:benefit ratio for children suffering from BP-NOS than currently available pharmacologic interventions. Psychoeducational psychotherapy (PEP) also has shown promise in treating bipolar spectrum disorders in children aged 8-12 (Fristad, 2006; Fristad, Verducci, Walters, & Young, 2009); its efficacy in treating BP-NOS specifically has not been determined. The current study compares Ω3, PEP, and their combination to a placebo supplement and active monitoring (AM) in a 12-week trial of 60 children with BP-NOS (15 each with Ω3, Ω3 plus PEP, PEP, and placebo, all with active monitoring). Primary goals are to determine: 1) feasibility of a) recruiting 60 participants in 2 years; b) participant retention over a 12-week trial; and 2) placebo-controlled effect sizes for Ω3, PEP, and combination treatment on manic and depressive symptoms. Secondary goals are to explore response curves over time, mediators and moderators, treatment response across a broad array of outcome variables, adherence to treatment, impact on physiologic parameters often worsened by mood stabilizing medications, and experience of side-effects in participants receiving Ω3 and/or PEP. Comparisons of results to a parallel study of children with depression with identical design will maximize knowledge gained. This pilot study of Ω3, PEP, and combined treatment will provide evidence about whether a larger trial is feasible and justified.

The investigators propose to conduct a 20 week open pilot study of Interpersonal and Social Rhythm Therapy (IPSRT) to treat individuals (n=18) with subthreshold bipolar (BP) who are currently depressed. The investigators will conduct a preliminary evaluation of sleep-wake and social rhythm patterns in study participants using questionnaires and actigraphy. Primary aims of this study are to evaluate feasibility of this treatment and assessment approach. Exploratory aims are to examine 1) sleep-wake and social rhythm patterns in subthreshold BP, 2) impact of IPSRT on symptoms and functioning over time and 3) relationship between sleep-wake and social rhythm patterns and treatment outcomes.

This study is designed to look at the effects of naltrexone on weight loss in individuals treated with antipsychotic medications. Naltrexone is an FDA approved medication for the management of alcohol dependence and drug dependence, but has not been fully evaluated for its effect on weight loss in individuals with severe mental illness (i.e. schizophrenia, schizoaffective disorder, bipolar disorder etc.) The purpose of this study is to find out how effective two different doses of oral naltrexone is on reducing body weight when compared to placebo (an inactive substance or "sugar pill").

The investigators will evaluate the efficacy of a comprehensive 12-week contingency management intervention for treating alcohol dependence for persons with severe mental illness who are seen within the context of a community mental health center setting. The primary contingency will be submission of alcohol-free urines. Additional reinforcers will be provided for intensive outpatient addiction treatment attendance. Reinforcers will be vouchers or actual items useful for day-to-day living. Participants will be 120 adults diagnosed with alcohol dependance and severe mental illness.

This study compared glutamate and other neurometabolites measured by proton magnetic resonance spectroscopy (1H-MRS) in bipolar I and II patients currently depressed with age-matched healthy controls. The study will also compare 1H-MRS of bipolar I and II patients before and after taking a 12-week course of lamotrigine. The goal of this study was to better understand the neurobiology of bipolar depression and how lamotrigine may therapeutically impact brain function and mood response. The hypothesis was that in comparison to non-remission participants, bipolar participants who achieve remission (defined as a Montgomery Asberg Depression Rating Scale (MADRS) score <12 at week 12) associated with lamotrigine monotherapy will exhibit a greater decrease in glutamate (Glu) and an increase in N-acetyl aspartate (NAA), reported as a cerebrospinal fluid (CSF)-corrected absolute concentration percent change from baseline to endpoint in anterior cingulate (AC) and dorsolateral prefrontal cortex (DLPFC).

The purpose of this study is to determine the initial (after 1-week of maintenance dosing) and extended (after 3-weeks of maintenance dosing) effect of topiramate, at doses up to 600 mg/day, on the steady-state pharmacokinetics (absorption, distribution and excretion of the drug by the body) of lithium carbonate in patients with bipolar disorders.

The objective of this study is to evaluate the efficacy, safety, and tolerability of cariprazine monotherapy versus placebo for the treatment of acute manic or mixed episodes associated with bipolar I disorder.

Long-term studies have emphasized that depressive symptoms and episodes account for majority of the illness burden experienced by individuals with bipolar disorder (BD). Previous studies have shown that blood levels of proteins called pro-inflammatory cytokines are abnormal in individuals with bipolar depression. The investigators hypothesize that preventing the production or release of pro-inflammatory cytokines will result in improvement of depressive symptoms in individuals with bipolar depression. Minocycline is a medication that inhibits the activation of immune cells (i.e. microglia) in the brain and reduces the production of pro-inflammatory cytokines. Treatment with minocycline has been shown to have antidepressant-like effects in animal studies and improve symptoms of individuals with schizophrenia. In this study, minocycline (100 mg twice a day) will be administered for 8 weeks to determine if it is an efficacious antidepressant for individuals with bipolar depression.

The primary outcome of this study is to determine if predictors of response can select a population of patients with MDD that is effectively treatable by augmentation with ziprasidone. Major depressive disorder (MDD) is a broad category, including many forms of depressive illness, including those with only a single major depressive episode, those with episodic recurrence with intervening well states, those with chronic depressive/anxious states without intervening euthymia, and those with manic symptoms that do not meet threshold definitions of full mania/hypomania. In this heterogenous, large diagnostic definition, important groups of patients do not appear to respond well to antidepressants, and, conversely, based on observational studies, may respond well to neuroleptics. These predictors of response have begun to be identified and may serve to better design studies of neuroleptics in depressive illnesses. Among these predictors of response in MDD are clinical features that are more similar to bipolar illness than unipolar depression. These include a family history of bipolar disorder, antidepressant-induced mania, highly recurrent depressive episodes (>5), atypical depression, early age of onset of depression (< age 20), failure to respond to antidepressants, and antidepressant tolerance (initial response followed by later loss of response). The investigators propose to use these predictors to pick out patients that are more likely to respond to Geodon for MDD. This will be the first RCT of these predictors of depressive response applied to neuroleptics.

The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).