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A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder

Exploring KarXT for treating manic episodes in Bipolar-I disorder.

Recruiting
18-65 years
All
Phase 3
Study Summary: This study looks at how well and safe the drug KarXT works for people with Bipolar-I Disorder experiencing manic episodes. Bipolar-I Disorder is a mental health condition with extreme mood swings, including mania, which is a period of feeling very excited or irritable. The study lasts up to seven weeks and includes different parts like screening and a three-week stay in a hospital where patients get either KarXT or a placebo (a pill with no active medicine) without knowing which they received. This is called a "double-blind" study. Key Points:
  • The study takes up to seven weeks, including a three-week hospital stay.
  • Participants must have Bipolar-I Disorder with recent manic episodes and need to stop all other psychiatric medications before starting.
  • Participants cannot have certain other mental health disorders or medical conditions like severe substance use issues or risk of suicidal behavior.
Study details
    Bipolar-I Disorder With Mania or Mania With Mixed Features

NCT06951698

Bristol-Myers Squibb

17 October 2026

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