Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07140913
The ClinicalTrials.gov registry entry for NCT07140913 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 424 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 330-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (28% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.
-
A Randomized Study of Azetukalner Versus Placebo in Depressive Episodes Associated With Bipolar I or II Disorder (Bipolar Depression)
RECRUITING · Phase 3
-
Safety and Tolerability Trial of Lumateperone in Pediatric Patients With Schizophrenia, Bipolar Disorder or Autism Spectrum Disorder
RECRUITING · Phase 3
-
Study of Aripiprazole (Abilify) in Children With Symptoms of Mania
COMPLETED · Phase 3
-
Study on the Efficacy, Safety, and Tolerability of Cariprazine Relative to Placebo in Participants With Bipolar I Depression
COMPLETED · Phase 3
-
Acute Treatment of Bipolar II Depression
COMPLETED · Phase 3
-
Triiodothyronine (T3) Supplementation in the Treatment of Bipolar and Unipolar Depression.
COMPLETED · Phase 3
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.