Safety Study of Sodium Divalproate in Bipolar Disorder in Adolescents
Bipolar Disorder- Main objective: To evaluate the clinical and physiological tolerance of sodium divalproate in manic, mixed or hypomanic episodes of bipolar disorder in adolescents treated for 6 months. - Secondary objective: To evaluate the efficacy of sodium divalproate in improving manic, mixed or hypomanic symptoms.
Safety and Tolerability of Ziprasidone in Children and Adolescents With Bipolar I Disorder (Manic...
Bipolar DisorderThe purpose of this study is to assess the safety and tolerability of ziprasidone during long-term open-label administration in children and adolescents (ages 10-17) with bipolar I disorder (manic or mixed)
Omega-3 Fatty Acids in Children and Adolescents With Bipolar Disorder
Bipolar DisorderThe purpose of this study is to test the hypothesis that flax oil, as an omega-3 fatty acid, will be superior to placebo in the maintenance treatment of bipolar disorder in children and adolescents. Our primary objective was to determine if flax oil is efficacious in the pediatric bipolar population for reducing symptoms of mania and depression. A secondary objective was to examine fatty acid levels as predictors of treatment response and symptom severity. This clinical trial evaluated whether supplementation with flax oil, containing the omega-3 fatty acid alpha-linolenic acid (alpha-LNA), safely reduced symptom severity in youth with bipolar disorder.
Validation of Multidimensional Assessment of THYmic States (MATHYS): A Study in a Population of...
Bipolar Disorder I or IIA non randomized study to validate the MATHYS Scale in a population of in and outpatients greater than or equal to 18 years of age, suffering from Bipolar Disorder I or II, and treated with olanzapine.
A Study of the Effectiveness and Safety of Risperidone Versus Placebo in the Treatment of Manic...
Bipolar DisordersManic EpisodeThe purpose of the study is to assess the effectiveness and safety of risperidone (an antipsychotic medication) versus placebo during 3 weeks of treatment of mania in patients with Bipolar I Disorder who are suffering a manic episode.
The Effects of Aripiprazole on Patients With Metabolic Syndrome
SchizophreniaSchizoaffective Disorder2 moreThe primary goal of this study is to assess the effect of aripiprazole on patients who developed metabolic syndrome while taking other second generation antipsychotic medications.
Prophylactic Effect of Lamotrigine Compared With Lithium in Bipolar Disorder
Bipolar DisorderThe purpose of this study is to compare lamotrigine with lithium in the long term treatment of bipolar disorder in terms of new episode preventive potentials.
An Add-On Trial of Quetiapine in Patients With Bipolar Disorder and Cocaine Dependence
Bipolar DisorderCocaine DependenceThe purpose of this study is to determine if quetiapine add-on therapy is associated with a decrease in cocaine use and craving and a greater improvement in mood.
An Open-Label Trial of Aripiprazole in Children and Adolescents With Bipolar Disorder
Bipolar DisorderThis is an investigator-initiated study whose primary aim is to determine the effectiveness of aripiprazole (Abilify®) in helping persons with symptoms of mania whose current medications do not completely control those symptoms. Aripiprazole is a medication that has been approved by the United States Food and Drug Administration (FDA) for the treatment of Schizophrenia. A secondary aim of this research is to explore whether CYP 2D6 polymorphisms are related to side effects with aripiprazole. The goal of this research is to identify individuals who metabolize aripiprazole more rapidly or slowly, which will potentially help the clinician make dosing adjustments and decrease the risk of adverse events.
A Double-Blind Randomized Placebo Controlled Study of Quetiapine for the Treatment of Depression...
Bipolar I DisorderIn this study, quetiapine is being tested for the possible treatment of bipolar I disorder with an acute depressive episode in children and adolescents. We hypothesize that quetiapine will be more efficacious than placebo for the treatment of episodes of major depression associated with adolescent BP. Moreover, we hypothesize that quetiapine will be safe and well-tolerated compared with placebo for the treatment of depression associated with adolescent BP. Based on data from the BOLDER study and other studies of atypical antipsychotics in patients with bipolar depression (Calabrese et al., 2004, Macfadden et al., 2004, Tohen et al., 2004), which in general reveal effect sizes of approximately 0.5, a conservative sample size calculation, assuming power of .8, estimates we would need approximately 15 patients in each group to identify a statistically significant group difference in our main outcome measure, change form baseline to endpoint in the Children's Depression Rating Scale (Poznanski, 1979).