What is KarXT studying for Bipolar-I Disorder?

KarXT is being studied to evaluate its effect on manic episodes in people with Bipolar-I Disorder. The trial aims to compare KarXT to a placebo to see how well it reduces mania symptoms during a 3-week inpatient period. The study is sponsored by Bristol-Myers Squibb to better understand treatment options for this condition.

Who may be eligible for this Bipolar-I Disorder clinical trial?

Adults aged 18 to 65 years with a diagnosis of Bipolar-I disorder experiencing an acute manic episode or mania with mixed features may be eligible. Participants must require hospitalization and have specific symptom scores. People with certain other mental health conditions or substance use disorders may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this Bipolar-I Disorder clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to attending study visits.

Actively Recruiting

Phase 3

Age: 18Years - 65Years

All Genders

ID06951698

Phase 3 Study of KarXT for Treating Manic Episodes in Bipolar-I Disorder

Led by Bristol-Myers Squibb · Updated on 2026-07-27

274

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating KarXT for the treatment of manic episodes in adults with Bipolar-I Disorder. This Phase 3, randomized, double-blind, placebo-controlled study involves participants experiencing an acute episode of mania or mania with mixed features. The study aims to compare the effectiveness and safety of KarXT against a placebo during a 3-week inpatient treatment period. Participants will receive flexible dosing of either KarXT or placebo during the 3-week double-blind inpatient phase. Before treatment, psychotropic medications must be washed out within 14 days. The study includes screening, the treatment period, and a safety follow-up, totaling no more than seven weeks. During the study, participants will have their symptoms assessed using tools such as the Young Mania Rating Scale and Clinical Global Impressions-Bipolar scale. Researchers will monitor changes in mania symptoms and overall clinical impression at week 3. Safety follow-up continues after treatment to ensure participant well-being throughout the study duration.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

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 will not qualify if you...

Participants must not have any primary DSM-5-TR disorder other than Bipolar-I with mania or mania with mixed features within 12 months before screening, including Bipolar-I with depression (for previous 3 months only), Bipolar-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, except mild anxiety disorders.
Participants must not have a primary diagnosis of Bipolar-I with rapid cycling (≥ 4 distinct mood episodes in one year).
Participants must not have moderate to severe substance use disorder (except tobacco use disorder) within 12 months before screening or current use as determined by urine toxicology or alcohol test.
Participants must not be at risk for suicidal behavior at screening or baseline as assessed by the Investigator and Columbia-Suicide Severity Rating Scale (C-SSRS).
Participants must not have a history of irritable bowel syndrome 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.

Research Team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

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

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Phase 3 Study of KarXT for Treating Manic Episodes in Bipolar-I Disorder

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria