Clinical Trial

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

Recruiting Phase 3
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Summary
The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.
Protocol Amendment History 20 amendments
This ClinicalTrials.gov record has been amended 20 times since 2025-08-21; most recent amendment 2026-06-22.
Status change: Not Yet Recruiting → Recruiting 2025-10-09
Trial Details
NCT Number NCT07140913
Lead Sponsor Bristol-Myers Squibb
Conditions Mania, Bipolar Disorder
Enrollment 424 participants
Start Date 2025-10-08
Primary Completion 2027-06-28 (estimated)
Study Completion 2027-06-28 (estimated)
Updated on ClinicalTrials.gov 2026-06-23