Status:
RECRUITING
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
Lead Sponsor:
Bristol-Myers Squibb
Conditions:
Mania
Bipolar Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 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 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
- 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 \[Child-Pugh Class C\]).
- Other protocol-defined Inclusion/Exclusion criteria apply.
Key Trial Info
Start Date :
October 8 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2027
Estimated Enrollment :
424 Patients enrolled
Trial Details
Trial ID
NCT07140913
Start Date
October 8 2025
End Date
June 28 2027
Last Update
January 9 2026
Active Locations (91)
Enter a location and click search to find clinical trials sorted by distance.
1
Pillar Clinical Research - Bentonville
Bentonville, Arkansas, United States, 72712
2
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States, 72204
3
Clinical Innovations, Inc. dba CITrials
Bellflower, California, United States, 90706
4
Inland Psychiatric Medical Group - Chino
Chino, California, United States, 91710