A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Public ClinicalTrials.gov record NCT06951698. 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 KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)
Study identification
- NCT ID
- NCT06951698
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Bristol-Myers Squibb
- Industry
- Enrollment
- 274 participants
Conditions and interventions
Interventions
- KarXT Drug
- Placebo Other
Drug · Other
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
- Jun 10, 2025
- Primary completion
- Oct 31, 2026
- Completion
- Oct 31, 2026
- Last update posted
- Apr 13, 2026
2025 – 2026
United States locations
- U.S. sites
- 22
- U.S. states
- 9
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Pillar Clinical Research - Bentonville | Bentonville | Arkansas | 72712 | Recruiting |
| Woodland International Research Group | Little Rock | Arkansas | 72211 | Recruiting |
| Advanced Research Center Inc. | Anaheim | California | 92805 | Recruiting |
| CITrials | Bellflower | California | 90706 | Recruiting |
| Local Institution - 0014 | Cerritos | California | 90703 | Not yet recruiting |
| Collaborative Neuroscience Research, LLC | Long Beach | California | 90806 | Recruiting |
| Catalina Research Institute, LLC | Montclair | California | 91763 | Recruiting |
| NRC Research Institute | Orange | California | 92868 | Recruiting |
| Connecticut Mental Health Center | New Haven | Connecticut | 06519 | Recruiting |
| Research Centers of America ( Hollywood ) | Hollywood | Florida | 33024 | Recruiting |
| Advanced Research Institute of Miami | Homestead | Florida | 33033 | Recruiting |
| South Florida Research Phase I-IV | Miami | Florida | 33166 | Recruiting |
| Innovative Clinical Research, Inc. | Miami Lakes | Florida | 33016 | Recruiting |
| Local Institution - 0015 | Miami Lakes | Florida | 33016 | Not yet recruiting |
| Health Synergy Clinical Research | West Palm Beach | Florida | 33407 | Recruiting |
| Synexus Clinical Research US, Inc. | Atlanta | Georgia | 30328 | Recruiting |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | Recruiting |
| Pillar Clinical Research -Chicago | Chicago | Illinois | 60641 | Recruiting |
| Richmond Behavioral Associates | Staten Island | New York | 10314 | Recruiting |
| Neuro-Behavioral Clinical Research | North Canton | Ohio | 44720 | Recruiting |
| Local Institution - 0029 | Irving | Texas | 75062 | Withdrawn |
| 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 41 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06951698, 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 13, 2026 · Synced May 20, 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 NCT06951698 live on ClinicalTrials.gov.