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

Examining KarXT's safety for treating manic episodes in Bipolar-I.

Recruiting
18-65 years
All
Phase 3

This study looks at the safety of a medicine called **KarXT** for people with *Bipolar-I Disorder*, a condition that causes intense mood swings, including manic episodes. **Manic episodes** are periods of very high energy or irritability. The study is in **Phase 3**, meaning the medicine has been tested before, but researchers want to see how safe it is over a long time. The study is **open-label**, so both doctors and participants know what treatment is being given.

Eligibility: To join, you either need to have finished a previous related study or have a primary diagnosis of Bipolar-I disorder. You should not have certain other health issues like rapid mood changes or severe substance use disorder.

  • Duration: It's a long-term study, so it may last several months.
  • Visits: Regular visits to the study center are needed for check-ups.
  • Risks: Participants with a history of suicidal behavior or certain health issues may not join.
Study details
    Bipolar Disorder Type I With Mania

NCT06929273

Bristol-Myers Squibb

17 October 2026

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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