Actively Recruiting
Phase 3 Study of KarXT Added to Lithium, Valproate, or Lamotrigine for Treating Mania in Bipolar-I Disorder
Led by Bristol-Myers Squibb · Updated on 2026-06-23
424
Participants Needed
104
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of adding KarXT to current treatment for mania in adults with Bipolar-I Disorder. Participants must be experiencing an acute manic episode, with or without mixed features, and currently taking lithium, valproate, or lamotrigine. The study is a Phase 3, randomized, double-blind, placebo-controlled trial assessing KarXT as an adjunctive therapy. Participants will be randomly assigned to receive either KarXT combined with lithium, valproate, or lamotrigine, or a placebo combined with these mood stabilizers. The study drug or placebo will be administered at specified doses on designated days. The trial focuses on treatment during an acute manic episode with monitoring over several weeks to assess changes in mania symptoms and other clinical outcomes. Participants will be monitored through scheduled visits where researchers will measure changes in mania severity using the Young Mania Rating Scale YMRS and other clinical scales. Safety assessments will include tracking adverse events and evaluating other symptom scales related to bipolar disorder. The total study duration includes treatment and follow-up periods lasting up to seven weeks, during which participants health and responses to the study drug are carefully observed.
CONDITIONS
Brief Title
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
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
F
First line of the email MUST contain NCT # and Site #.
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
