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NCT07140913 · ClinicalTrials.gov registry record · Phase 3
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 study of Bipolar Disorder and Mania, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 424
- Enrollment target
- 20
- Study locations
NCT07140913: Recruiting Phase 3 study of Bipolar Disorder and Mania, sponsored by Bristol-Myers Squibb.
NCT07140913 is a Phase 3 study of Bipolar Disorder and Mania that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 424 participants, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (28% higher). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07140913, a Phase 3 study of Bipolar Disorder and Mania, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 424 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Lamotrigine
- DRUG Xanomeline/Trospium Chloride
- DRUG Lithium
- DRUG Valproate
Study Locations (20)
California
- Clinical Innovations, Inc. dba CITrials - Bellflower
- Inland Psychiatric Medical Group - Chino - Chino
- Proscience Research Group - Culver City
- Omega Clinical Trials - La Habra - La Habra
- Catalina Research Institute, LLC - Montclair
- NRC Research Institute - Orange
- Clinical Innovations, Inc. dba CITrials - Riverside
Texas
- Community Clinical Research - Austin
- Local Institution - 0160 - Houston
- Prime Clinical Research - Mansfield - Mansfield
- Pillar Clinical Research - Richardson - Richardson
Florida
- Velocity Clinical Research, Hallandale Beach - Hallandale
- South Florida Research Phase I-IV - Miami Springs
- Health Synergy Clinical Research - Stuart
Arkansas
- Pillar Clinical Research - Bentonville - Bentonville
- Pillar Clinical Research- Little Rock - Little Rock
Georgia
- CenExel iResearch, LLC - Savannah
Illinois
- Pillar Clinical Research -Chicago - Chicago
Missouri
- Arch Clinical Trials - St Louis
New York
- Richmond Behavioral Associates - Staten Island
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 424 participants |
| Start Date | 2025-10-08 |
| Est. Completion | 2027-06-28 |
| Phase | Phase 3 |
What NCT07140913 shows while recruiting
NCT07140913 is an interventional study that assigns participants to a tested intervention. The registered 424 participants enrollment target is mid-sized for trials with a published cap, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (28% higher).
The record links to 2 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 5 interventions - of which Placebo is the first listed.
NCT07140913 names 20 study sites across 8 states, led by California, Texas, Florida.
Frequently Asked Questions
What is clinical trial NCT07140913 about?
NCT07140913 is a clinical study titled "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". 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.
What is the current status of trial NCT07140913?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 424 participants. The study started on 2025-10-08. Estimated completion is 2027-06-28.
What conditions does trial NCT07140913 study?
This clinical trial studies the following conditions: Bipolar Disorder, Mania.
What interventions are being tested in trial NCT07140913?
The interventions under investigation include: Placebo (DRUG), Lamotrigine (DRUG), Xanomeline/Trospium Chloride (DRUG), Lithium (DRUG), Valproate (DRUG).
Who is sponsoring clinical trial NCT07140913?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07140913 being conducted?
This trial has 20 study locations across Arkansas, California, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07140913's enrollment target sits among peer trials
424 16th of 162 higher than 147 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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