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

KarXTA 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

Sponsor:

Bristol-Myers Squibb

Code:

NCT07140913

Conditions

Mania

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Xanomeline/Trospium Chloride

Lithium

Valproate

Lamotrigine

Placebo

Study Details

Eligibility Criteria

Study Design

Interventions and Outcome Measures

Central Contacts and Locations

More Information

Trial information was received from ClinicalTrials.gov and was last updated on 2025-11-02. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2025-10-14.