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A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Testing KarXT for mania in Bipolar-I patients on specific medications.

Recruiting
18-65 years
All
Phase 3
  • Simplified description (AI rewritten)
  • Technical description (Original)

This study is checking if a drug called KarXT is safe and helpful for treating mania in people with Bipolar-I Disorder. Bipolar-I Disorder is a mood condition that can cause extreme mood swings, including intense excitement called mania. Eligibility for this study includes having a confirmed diagnosis of Bipolar-I and currently experiencing a manic episode. Participants must already be taking certain mood stabilizers like lithium, valproate, or lamotrigine.

Key Points:

  • The study involves taking an additional medication, KarXT, along with your current mood stabilizer.
  • It is important to have a stable dose of your current medication for at least two weeks before starting.
  • Risks include possible side effects from KarXT or interactions with other medications.

Some people cannot join, like those with other mental health disorders, substance abuse issues, or certain medical conditions. Participants will need a psychiatric evaluation and meet specific criteria to join this study. It's vital to discuss with your doctor if this study is suitable for you.

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Study details
    Mania
    Bipolar Disorder

NCT07140913

Bristol-Myers Squibb

7 March 2026

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