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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Bipolar Disorder Type I With Mania or Mania With Mixed Features

In brief

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.

Key facts

Study ID

NCT06951711

Run by

Bristol-Myers Squibb

People needed

274

Starts

2025-06-13

Expected to finish

2026-11-02

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
• Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
• Participants must require hospitalization for the acute exacerbation or relapse of mania.
• Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
• Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
• Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.

You may not qualify if…

• Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
• Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
• Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.
• Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Participants must not have cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Klinika za psihijatriju "Vrapče" — Zagreb, Croatia (enrolling)
• Klinika za psihijatriju "Vrapče" — Zagreb, Croatia (enrolling)
• Pillar Clinical Research - Richardson — Richardson, Texas, United States (enrolling)
• Klinika za psihijatriju "Vrapče" — Zagreb, Croatia (enrolling)
• Proscience Research Group — Culver City, California, United States (enrolling)
• Pillar Clinical Research- Little Rock — Little Rock, Arkansas, United States (enrolling)
• LCC Medical Research Institute — Miami, Florida, United States (enrolling)
• Clinical Innovations, Inc. dba CITrials — Riverside, California, United States (enrolling)
• Woodland Research Northwest — Rogers, Arkansas, United States (enrolling)
• Pillar Clinical Research — Richardson, Texas, United States (enrolling)
• Health Synergy Clinical Research — West Palm Beach, Florida, United States (enrolling)
• Atlanta Center for Medical Research — Atlanta, Georgia, United States (enrolling)
• CenExel iResearch, LLC — Decatur, Georgia, United States (enrolling)
• Behavioral Clinical Research — Hollywood, Florida, United States (enrolling)
• CBH Health — Gaithersburg, Maryland, United States (enrolling)
• Precise Research Centers — Flowood, Mississippi, United States (enrolling)
• Arch Clinical Trials — St Louis, Missouri, United States (enrolling)
• Innovative Clinical Research, Inc. — Miami Lakes, Florida, United States (enrolling)
• Hassman Research Institute Marlton Site — Marlton, New Jersey, United States (enrolling)
• South Florida Research Phase I-IV — Miami Springs, Florida, United States (enrolling)
• Collaborative Neuroscience Research, LLC — Torrance, California, United States (enrolling)
• University of Cincinnati Medical Center — Cincinnati, Ohio, United States (enrolling)
• Neuro-Behavioral Clinical Research — North Canton, Ohio, United States (enrolling)
• Adams Clinical Dallas — DeSoto, Texas, United States (enrolling)
• Psihijatrijska bolnica "Sveti Ivan" — Zagreb, Croatia (enrolling)

Full record on ClinicalTrials.gov

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