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

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

Recruiting
18-65 years
All
Phase 3

**KarXT** is a medication being studied to help treat manic episodes in **Bipolar-I Disorder**, which is a mental condition causing extreme mood swings. This study is called **BALSAM-2**. It's a **Phase 3** study, meaning it's in late stages to check safety and how well it works. The study will last up to seven weeks, including checking participants' health before and after treatment. During the study, participants stay in a hospital for three weeks to try either KarXT or a **placebo** (a pill with no medicine) without knowing which they receive. This is done to compare results fairly.

  • **Duration**: Up to 7 weeks, including a 3-week hospital stay.
  • **Eligibility**: Must have Bipolar-I disorder with a recent manic episode.
  • **Risks**: No participation if severe substance use, other primary mental disorders, or liver issues.
Study details
    Bipolar Disorder Type I With Mania or Mania With Mixed Features

NCT06951711

Bristol-Myers Squibb

7 March 2026

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