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Study identifier: NCT06951711 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Bipolar Disorder Type I With Mania or Mania With Mixed Features  ·  Sponsor: Bristol-Myers Squibb

PhasePhase 3
Planned participants274
Who can joinAll sexes, 18 Years to 65 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com  ·  855-907-3286  ·  Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.

Always discuss trial participation with your own doctor first.

Locations (85)

Pillar Clinical Research- Little RockLittle Rock, Arkansas, United StatesRecruiting
Woodland Research NorthwestRogers, Arkansas, United StatesRecruiting
Proscience Research GroupCulver City, California, United StatesRecruiting
Clinical Innovations, Inc. dba CITrialsRiverside, California, United StatesRecruiting
Collaborative Neuroscience Research, LLCTorrance, California, United StatesRecruiting
Local Institution - 0036Hialeah Gardens, Florida, United StatesWithdrawn
Behavioral Clinical ResearchHollywood, Florida, United StatesRecruiting
LCC Medical Research InstituteMiami, Florida, United StatesRecruiting
Innovative Clinical Research, Inc.Miami Lakes, Florida, United StatesRecruiting
South Florida Research Phase I-IVMiami Springs, Florida, United StatesRecruiting
Local Institution - 0019Tampa, Florida, United StatesWithdrawn
Health Synergy Clinical ResearchWest Palm Beach, Florida, United StatesRecruiting

+ 73 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06951711