NCT07140913From ClinicalTrials.govRecruiting

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

Mania
Bipolar Disorder

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Bristol-Myers Squibb
Enrolment target: 424
Started: 8 October 2025
Main results due: 28 June 2027
Study sites: 104
Registry updated: 23 June 2026

Can you take part?

Ages 18 years to 65 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.
* 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 Criteria:

* 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 \[Child-Pugh Class C\]).
* Other protocol-defined Inclusion/Exclusion criteria apply.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(104)

Pillar Clinical Research - Bentonville
Bentonville, Arkansas, United States
Recruiting
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States
Recruiting
Clinical Innovations, Inc. dba CITrials
Bellflower, California, United States
Recruiting
Inland Psychiatric Medical Group.
Chino, California, United States
Recruiting
Proscience Research Group
Culver City, California, United States
Recruiting
Omega Clinical Trials - La Habra
La Habra, California, United States
Recruiting
Catalina Research Institute, LLC
Montclair, California, United States
Recruiting
NRC Research Institute
Orange, California, United States
Recruiting
Clinical Innovations, Inc. dba CITrials
Riverside, California, United States
Recruiting
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States
Recruiting
South Florida Research Phase I-IV
Miami, Florida, United States
Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, United States
Recruiting
CenExel iResearch, LLC
Savannah, Georgia, United States
Recruiting
Pillar Clinical Research -Chicago
Chicago, Illinois, United States
Recruiting
Arch Clinical Trials
St Louis, Missouri, United States
Recruiting
Richmond Behavioral Associates
Staten Island, New York, United States
Recruiting
Community Clinical Research
Austin, Texas, United States
Recruiting
Elevate Clinical Research-Houston
Houston, Texas, United States
Recruiting
Prime Clinical Research - Mansfield
Mansfield, Texas, United States
Recruiting
Pillar Clinical Research - Richardson
Richardson, Texas, United States
Recruiting
Local Institution - 0011
ABB, Buenos Aires F.D., Argentina
Not yet recruiting
Local Institution - 0010
Córdoba, Argentina
Not yet recruiting
Local Institution - 0012
Córdoba, Argentina
Not yet recruiting
Local Institution - 0008
Córdoba, Argentina
Not yet recruiting
Local Institution - 0009
Mendoza, Argentina
Not yet recruiting
Local Institution - 0114
Santiago del Estero, Argentina
Not yet recruiting
Local Institution - 0184
Kazanlak, Stara Zagora, Bulgaria
Not yet recruiting
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
Novi Iskar, Bulgaria
Recruiting
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, Bulgaria
Recruiting
Local Institution - 0181
Sliven, Bulgaria
Not yet recruiting
Local Institution - 0086
Targovishte, Bulgaria
Not yet recruiting
Local Institution - 0185
Beijing, Beijing Municipality, China
Not yet recruiting
Local Institution - 0190
Beijing, Beijing Municipality, China
Not yet recruiting
Local Institution - 0191
Guangzhou, Guangdong, China
Not yet recruiting
Local Institution - 0193
Baoding, Hebei, China
Not yet recruiting
Local Institution - 0187
Shijiazhuang, Hebei, China
Not yet recruiting
Local Institution - 0196
Nanjing, Jiangsu, China
Not yet recruiting
Local Institution - 0186
Xi'an, Shaanxi, China
Not yet recruiting
Local Institution - 0192
Chengdu, Sichuan, China
Not yet recruiting
Local Institution - 0188
Tianjin, Tianjin Municipality, China
Not yet recruiting
Local Institution - 0197
Ningbo, Zhejiang, China
Not yet recruiting
Local Institution - 0195
Changsha, China
Not yet recruiting
Local Institution - 0088
Hillerød, Capital Region, Denmark
Not yet recruiting
Local Institution - 0054
Aalborg, North Denmark, Denmark
Not yet recruiting
Local Institution - 0091
Glostrup Municipality, Denmark
Not yet recruiting
Local Institution - 0126
Nice, Alpes-Maritimes, France
Not yet recruiting
Local Institution - 0085
Clermont-Ferrand, Puy-de-Dôme, France
Not yet recruiting
Local Institution - 0087
Marseille, France
Withdrawn
Local Institution - 0129
Montpellier, France
Not yet recruiting
Local Institution - 0089
Paris, France
Withdrawn
Local Institution - 0121
Mangalore, Karnataka, India
Not yet recruiting
Local Institution - 0123
Madurai, Tamil Nadu, India
Not yet recruiting
Local Institution - 0118
Kolkata, West Bengal, India
Not yet recruiting
Local Institution - 0116
Kolkata, India
Not yet recruiting
Local Institution - 0052
Hod HaSharon, Central District, Israel
Not yet recruiting
Sheba Medical Center
Ramat Gan, Central District, Israel
Recruiting
Local Institution - 0053
Ashkelon, Southern District, Israel
Not yet recruiting
Be'er Sheva Mental Health Center
Beersheba, Southern District, Israel
Recruiting
Local Institution - 0083
Jerusalem, Israel
Not yet recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
Recruiting

Showing 60 of 104 sites — filter to narrow it down. 43 of the 104 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07140913. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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