NCT06951698

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

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 274 (estimated)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects 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.

Conditions

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

Interventions

Type	Name	Description
DRUG	KarXT	Specified dose on specified days
OTHER	Placebo	Specified dose on specified days

Timeline

• Start date: 2025-06-11
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-04-30
• Last updated: 2026-04-14

Locations

63 sites across 8 countries: United States, Argentina, Australia, Bulgaria, Hungary, Japan, New Zealand, Poland

Regulatory

• FDA-regulated drug study