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
Public ClinicalTrials.gov record NCT07140913. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT07140913
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bristol-Myers Squibb
- Industry
- Enrollment
- 424 participants
Conditions and interventions
Conditions
Interventions
- Placebo Drug
- Xanomeline/Trospium Chloride Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 65 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Oct 7, 2025
- Primary completion
- Jun 27, 2027
- Completion
- Jun 27, 2027
- Last update posted
- Apr 29, 2026
2025 – 2027
United States locations
- U.S. sites
- 20
- U.S. states
- 8
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pillar Clinical Research - Bentonville | Bentonville | Arkansas | 72712 | Recruiting |
| Pillar Clinical Research- Little Rock | Little Rock | Arkansas | 72204 | Recruiting |
| Clinical Innovations, Inc. dba CITrials | Bellflower | California | 90706 | Recruiting |
| Inland Psychiatric Medical Group. | Chino | California | 91710 | Recruiting |
| Proscience Research Group | Culver City | California | 90230 | Recruiting |
| Omega Clinical Trials - La Habra | La Habra | California | 90631 | Recruiting |
| Catalina Research Institute, LLC | Montclair | California | 91763 | Recruiting |
| NRC Research Institute | Orange | California | 92868 | Recruiting |
| Clinical Innovations, Inc. dba CITrials | Riverside | California | 92506 | Recruiting |
| Velocity Clinical Research, Hallandale Beach | Hallandale | Florida | 33009 | Recruiting |
| South Florida Research Phase I-IV | Miami | Florida | 33166 | Recruiting |
| Health Synergy Clinical Research | West Palm Beach | Florida | 33407 | Recruiting |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | Recruiting |
| Pillar Clinical Research -Chicago | Chicago | Illinois | 60641 | Recruiting |
| Arch Clinical Trials | St Louis | Missouri | 63141 | Recruiting |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | Recruiting |
| Community Clinical Research | Austin | Texas | 78754 | Recruiting |
| Local Institution - 0160 | Houston | Texas | 77058 | Not yet recruiting |
| Prime Clinical Research - Mansfield | Mansfield | Texas | 76063 | Recruiting |
| Pillar Clinical Research - Richardson | Richardson | Texas | 75080 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 81 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07140913, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2026 · Synced May 8, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07140913 live on ClinicalTrials.gov.