Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06951698 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
A Phase 3 study of Bipolar-I Disorder With Mania or Mania With Mixed Features, sponsored by Bristol-Myers Squibb.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 274
- Enrollment target
- 20
- Study locations
NCT06951698: Recruiting Phase 3 study of Bipolar-I Disorder With Mania or Mania With Mixed Features, sponsored by Bristol-Myers Squibb.
NCT06951698 is a Phase 3 study of Bipolar-I Disorder With Mania or Mania With Mixed Features that is actively recruiting participants, run by Bristol-Myers Squibb. The registered enrollment target is 274 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06951698, a Phase 3 study of Bipolar-I Disorder With Mania or Mania With Mixed Features, is actively recruiting participants, sponsored by Bristol-Myers Squibb.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 274 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
Primary Outcome
The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG KarXT
Study Locations (20)
California
- Advanced Research Center Inc. - Anaheim
- CITrials - Bellflower
- Local Institution - 0014 - Cerritos
- Collaborative Neuroscience Research, LLC - Long Beach
- Catalina Research Institute, LLC - Montclair
- NRC Research Institute - Orange
Florida
- Research Centers of America ( Hollywood ) - Hollywood
- Advanced Research Institute of Miami - Homestead
- Innovative Clinical Research, Inc. - Miami Lakes
- Local Institution - 0015 - Miami Lakes
- South Florida Research Phase I-IV - Miami Springs
- Health Synergy Clinical Research - West Palm Beach
Arkansas
- Pillar Clinical Research - Bentonville - Bentonville
- Woodland International Research Group - Little Rock
Georgia
- Synexus Clinical Research US, Inc. - Atlanta
- CenExel iResearch, LLC - Savannah
Connecticut
- Connecticut Mental Health Center - New Haven
Illinois
- Pillar Clinical Research -Chicago - Chicago
New York
- Richmond Behavioral Associates - Staten Island
Ohio
- Neuro-Behavioral Clinical Research - North Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 274 participants |
| Start Date | 2025-06-11 |
| Est. Completion | 2026-11-01 |
| Phase | Phase 3 |
What NCT06951698 shows while recruiting
NCT06951698 is an interventional study that assigns participants to a tested intervention. The registered 274 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (65% lower).
The record links to 1 condition, with Bipolar-I Disorder With Mania or Mania With Mixed Features appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06951698 names 20 study sites across 8 states, led by California, Florida, Arkansas.
Frequently Asked Questions
What is clinical trial NCT06951698 about?
NCT06951698 is a clinical study titled "A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder". The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder
What is the current status of trial NCT06951698?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 274 participants. The study started on 2025-06-11. Estimated completion is 2026-11-01.
What conditions does trial NCT06951698 study?
This clinical trial studies the following conditions: Bipolar-I Disorder With Mania or Mania With Mixed Features.
What interventions are being tested in trial NCT06951698?
The interventions under investigation include: Placebo (OTHER), KarXT (DRUG).
Who is sponsoring clinical trial NCT06951698?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06951698 being conducted?
This trial has 20 study locations across Arkansas, California, Connecticut, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06951698's enrollment target sits among peer trials
274 1208th of 2000 higher than 788 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03808922 · 274 participants · Phase 3
Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study
- NCT04573504 · 274 participants · Phase 4
Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair
- NCT05289557 · 274 participants · Phase 3
The Efficacy and Safety of Bonjesta® for Nausea and Vomiting of Pregnancy in Pregnant Adolescents
- NCT05952583 · 274 participants
Selective Fetal Growth Restriction in Monochorionic Twins - an International Investigation
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI