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A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine | Clinical Trials | Clareo Health

RECRUITINGPHASE3

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

NCT07140913•Bristol-Myers Squibb

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2 Standard.
•Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).
•The individual requires hospitalization for the acute exacerbation or relapse of mania.
•Body mass index ≥ 18 and ≤ 40 kg/m2
•Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.
•YMRS Total Score of ≥ 18 at Screening and at Baseline, and \< 20% reduction in YMRS from screening to baseline.
•Clinical Global Impression Severity scale (CGI-BP) ≥ 4

Exclusion Criteria

•Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 Standard) including BP-I depression, BP-I with rapid cycling, first manic episode, BP-II, and major depressive disorder.
•Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 Standard at screening), or current use as determined by urine toxicology screen or alcohol test.
•Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or suicide attempt within 12 months before screening, or between screening and baseline
•History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.
•History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
•Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results.
•Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT and AST and/or bilirubin \> 1.5× ULN, unless in the context of Gilbert's syndrome.
•All grades of hepatic impairment (mild \[Child-Pugh Class A\], moderate \[Child-Pugh Class B\], and severe \[Child-Pugh Class C\]).

Locations (101)

Pillar Clinical Research - Bentonville

Bentonville, Arkansas, United States

Pillar Clinical Research- Little Rock

Little Rock, Arkansas, United States

Clinical Innovations, Inc. dba CITrials

Bellflower, California, United States

Inland Psychiatric Medical Group - Chino

Chino, California, United States

Proscience Research Group

Culver City, California, United States

Omega Clinical Trials - La Habra

La Habra, California, United States

Catalina Research Institute, LLC

Montclair, California, United States

NRC Research Institute

Orange, California, United States

Clinical Innovations, Inc. dba CITrials

Riverside, California, United States

Velocity Clinical Research, Hallandale Beach

Hallandale, Florida, United States

Key Dates

Start Date

October 8, 2025

Primary Completion Date

June 28, 2027

Completion Date

June 28, 2027

Last Updated

February 23, 2026

Enrollment

424

ESTIMATED participants

Conditions

ManiaBipolar Disorder

Interventions

Xanomeline/Trospium Chloride

DRUG

Lithium

DRUG

Valproate

DRUG

Lamotrigine

DRUG

Placebo

DRUG

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

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

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 23, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

Inclusion Criteria

Exclusion Criteria

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