Treatment Trials

6 Clinical Trials for Various Conditions

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COMPLETED
An Outpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder in Children and Adolescents
Description

The purpose of this study is to determine the safety and effectiveness of Depakote ER (Divalproex Sodium Extended-Release Tablets) compared to placebo in the treatment of bipolar disorder, manic or mixed type in children and adolescents ages 10-17 years.

NOT_YET_RECRUITING
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

NOT_YET_RECRUITING
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Description

This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.

COMPLETED
An Inpatient Study of the Effectiveness and Safety of Depakote ER in the Treatment of Mania/Bipolar Disorder
Description

The purpose of this study is to determine the safety and effectiveness of Depakote ER compared to placebo in the treatment of bipolar disorder, manic or mixed type in adults.

ENROLLING_BY_INVITATION
BHV-7000 Open-Label Extension Bipolar Mania Study
Description

The purpose of this study is to evaluate the long-term safety and tolerability of BHV-7000 in subjects with bipolar I disorder.

COMPLETED
BHV-7000 Acute Treatment of Bipolar Mania
Description

The purpose of this study is to determine whether BHV-7000 is a safe and effective acute treatment for manic episodes in bipolar disorder I.