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

Summary

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

• Bipolar Disorder Type I With Mania or Mania With Mixed Features

Eligibility basics and study details

Study type

Interventional

Phase

Phase 3

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Sponsor

Bristol-Myers Squibb

Last updated on ClinicalTrials.gov

September 24, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites