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Study of KarXT for Manic Episodes in Bipolar-I Disorder

This study is looking into how well KarXT works and if it's safe for people experiencing manic episodes (periods of unusually high energy or mood) due to Bipolar-I disorder. You might be able to join if you are 18 to 65 years old, have a diagnosis of Bipolar-I disorder, are currently having a manic episode or a manic episode with mixed features (both manic and depressive symptoms at the same time), and need to be hospitalized. The main goal is to see if KarXT can improve mania symptoms compared to a placebo (an inactive substance) over three weeks. The study is currently unclear about its recruitment status.

Study design
This is a Phase 3, randomized, double-blind study where some participants receive KarXT and others receive a placebo. It plans to enroll 274 participants.
What's involved
The study involves a screening period, a three-week inpatient treatment period, and a safety follow-up, lasting no more than seven weeks in total.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for safety after the three-week inpatient treatment period, with the total study duration being no more than seven weeks.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06951711

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

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Bristol-Myers Squibb
~274 participants
Updated 2026-08-18 on ClinicalTrials.gov
What's tested:KarXTPlacebo

At a glance

Recruiting sites
47 of 85 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in Young Mania Rating Scale (YMRS) score
Measured over At week 3

Conditions

Bipolar Disorder Type I With Mania or Mania With Mixed Features

Explore related trials

Bipolar Disorder

Where it's being run

85 sites across 47 states
Florida7
Bucharest7
Texas4
Croatia4
Central District4
Romania4
California3
Ukraine3

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Change from baseline in Young Mania Rating Scale (YMRS) scoreAt week 3

    The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity.