KarXT for treating manic episodes in bipolar I disorder (BALSAM-2)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

BALSAM-2 is a Phase 3, randomized, double-blind, placebo-controlled, multicenter inpatient trial comparing KarXT to placebo in adults hospitalized for acute mania or mania with mixed features. Participants must have a primary diagnosis of bipolar I disorder, a YMRS score ≥20 and CGI-BP ≥4, require hospitalization, and undergo washout of other psychotropic medications before dosing. The core double-blind inpatient treatment period lasts up to three weeks, and total participation including screening and safety follow-up is no more than seven weeks. Standard mania rating scales and safety monitoring are used to measure symptom change and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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's running

• Pillar Clinical Research- Little Rock
  Little Rock, Arkansas, United States Recruiting
• Woodland Research Northwest
  Rogers, Arkansas, United States Recruiting
• Proscience Research Group
  Culver City, California, United States Recruiting
• Clinical Innovations, Inc. dba CITrials
  Riverside, California, United States Recruiting
• Collaborative Neuroscience Research, LLC
  Torrance, California, United States Recruiting
• Health Synergy Clinical Research
  Boynton Beach, Florida, United States Recruiting

+36 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.