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A Study of KarXT for Mania in Bipolar-I Disorder

This study is looking into how well and how safely a medication called KarXT (Xanomeline/Trospium Chloride) works for people with Bipolar-I Disorder who are experiencing mania (a period of elevated or irritable mood and increased energy). You could be eligible if you are between 18 and 65 years old, have a diagnosis of Bipolar-I Disorder, and are currently having a manic episode. The study will compare KarXT to a placebo (an inactive substance) to see if KarXT helps reduce manic symptoms. Success in this study will be measured by changes in your Young Mania Rating Scale (YMRS) score after 5 weeks. The study plans to enroll 424 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 424 participants to compare KarXT with a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 5, indicating follow-up for at least that duration.

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

NCT07140913

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

Recruiting
PHASE3Ages 18–65InterventionalTreatment
Bristol-Myers Squibb
~424 participants
Updated 2026-06-23 on ClinicalTrials.gov
What's tested:Xanomeline/Trospium ChloridePlacebo

At a glance

Recruiting sites
43 of 104 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) at Week 5
Measured over At Week 5

Conditions

Mania
Bipolar Disorder

Explore related trials

Bipolar DisorderMania

Where it's being run

104 sites across 60 states
California7
Romania6
Argentina5
Bucharest5
Texas4
Bulgaria4
Tokyo4
Florida3

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

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.
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.

Exclusion

Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders.
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 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 "Yes" to any of the 5 items (C-SSRS behavior) with an event occurring within the 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 or 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 \[Child-Pugh Class C\]).

What this trial measures

  • Change from baseline in Young Mania Rating Scale (YMRS) at Week 5At Week 5