Actively Recruiting
Phase 3 Study of KarXT Versus Placebo for Treating Manic Episodes in Bipolar I Disorder
Led by Bristol-Myers Squibb · Updated on 2026-07-20
274
Participants Needed
85
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of KarXT for treating manic episodes in adults with Bipolar-I disorder. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess KarXTs ability to reduce mania symptoms during a 3-week inpatient treatment period. The study includes participants experiencing acute manic episodes or mania with mixed features who require hospitalization. Participants will receive either KarXT or a placebo with flexible dosing during the 3-week inpatient treatment. Before treatment, psychotropic medications must be washed out within 14 days. The study also includes screening before treatment and a safety follow-up, with the entire study lasting up to seven weeks. During the study, participants will be closely monitored with assessments including the Young Mania Rating Scale YMRS and Clinical Global Impressions-Bipolar CGI-BP to measure symptom changes. Safety evaluations and follow-up visits are part of the process, with researchers focusing on symptom improvement and safety over the study duration.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Research Team
B
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