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

Recruiting now · Phase 3 · Has a placebo group

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

In brief

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

Key facts

Study ID

NCT06951698

Run by

Bristol-Myers Squibb

People needed

274

Starts

2025-06-11

Expected to finish

2026-11-01

Last updated by the study team

2026-07-27

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 a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
• Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
• Other protocol-defined Inclusion/Exclusion criteria apply.

Where it is running

• Ramsay Clinic New Farm — Brisbane, Queensland, Australia (enrolling)
• Center for Mental Health Prof. Dr. Ivan Temkov — Burgas, Bulgaria (enrolling)
• CITrials — Bellflower, California, United States (enrolling)
• Ramsay Clinic Northside — St Leonards, New South Wales, Australia (enrolling)
• Collaborative Neuroscience Research, LLC — Long Beach, California, United States (enrolling)
• Advanced Research Center Inc. — Anaheim, California, United States (enrolling)
• Catalina Research Institute, LLC — Montclair, California, United States (enrolling)
• Connecticut Mental Health Center — New Haven, Connecticut, United States (enrolling)
• Woodland International Research Group — Little Rock, Arkansas, United States (enrolling)
• Advanced Research Institute of Miami — Homestead, Florida, United States (enrolling)
• South Florida Research Phase I-IV — Miami, Florida, United States (enrolling)
• Innovative Clinical Research, Inc. — Miami Lakes, Florida, United States (enrolling)
• NRC Research Institute — Los Angeles, California, United States (enrolling)
• Health Synergy Clinical Research — West Palm Beach, Florida, United States (enrolling)
• Synexus Clinical Research US, Inc. — Atlanta, Georgia, United States (enrolling)
• CenExel iResearch, LLC — Savannah, Georgia, United States (enrolling)
• Pillar Clinical Research -Chicago — Chicago, Illinois, United States (enrolling)
• Richmond Behavioral Associates — Staten Island, New York, United States (enrolling)
• Neuro-Behavioral Clinical Research — North Canton, Ohio, United States (enrolling)
• Research Centers of America ( Hollywood ) — Hollywood, Florida, United States (enrolling)
• Pillar Clinical Research - Richardson — Richardson, Texas, United States (enrolling)
• Hospital Italiano de Buenos Aires — ABB, Buenos Aires F.D., Argentina (enrolling)
• Clinica del Prado — Las Heras, Mendoza Province, Argentina (enrolling)
• Sanatorio Morra S.A. — Córdoba, Argentina (enrolling)
• State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar — Novi Iskar, Bulgaria (enrolling)

Full record on ClinicalTrials.gov

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