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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

NCT07140913

This study is recruiting at 20 US sites in 8 states, according to its ClinicalTrials.gov record last updated .

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.

Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov

Conditions studied

  • Mania
  • Bipolar Disorder

Eligibility basics and study details

Study type
Interventional
Phase
Phase 3
Ages
18 to 65 years
Sex
All
Healthy volunteers
Not accepted
Sponsor
Bristol-Myers Squibb
Last updated on ClinicalTrials.gov
June 23, 2026

These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.

US recruiting sites

Arkansas · 2

  • Pillar Clinical Research - Bentonville · Bentonville, AR
  • Pillar Clinical Research- Little Rock · Little Rock, AR

California · 7

  • Clinical Innovations, Inc. dba CITrials · Bellflower, CA
  • Inland Psychiatric Medical Group. · Chino, CA
  • Proscience Research Group · Culver City, CA
  • Omega Clinical Trials - La Habra · La Habra, CA
  • Catalina Research Institute, LLC · Montclair, CA
  • NRC Research Institute · Orange, CA
  • Clinical Innovations, Inc. dba CITrials · Riverside, CA

Florida · 3

  • Velocity Clinical Research, Hallandale Beach · Hallandale, FL
  • South Florida Research Phase I-IV · Miami, FL
  • Health Synergy Clinical Research · West Palm Beach, FL

Georgia · 1

  • CenExel iResearch, LLC · Savannah, GA

Illinois · 1

  • Pillar Clinical Research -Chicago · Chicago, IL

Missouri · 1

  • Arch Clinical Trials · St Louis, MO

New York · 1

  • Richmond Behavioral Associates · Staten Island, NY

Texas · 4

  • Community Clinical Research · Austin, TX
  • Elevate Clinical Research-Houston · Houston, TX
  • Prime Clinical Research - Mansfield · Mansfield, TX
  • Pillar Clinical Research - Richardson · Richardson, TX

Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.