NCT06929273

A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)

RecruitingPHASE3INTERVENTIONAL

Trial Details

Start: 2025-07-18Est. Completion: 2028-06-13

Enrollment target: 450 participants

Locations

Local Institution - 0120, Glendale, Arizona, United States
Pillar Clinical Research - Richardson, Bentonville, Arkansas, United States
Pillar Clinical Research- Little Rock, Little Rock, Arkansas, United States
Woodland International Research Group, Little Rock, Arkansas, United States
Woodland Research Northwest, Rogers, Arkansas, United States
Advanced Research Center Inc., Anaheim, California, United States
Clinical Innovations, Inc. dba CITrials, Bellflower, California, United States
Local Institution - 0044, Cerritos, California, United States
Inland Psychiatric Medical Group - Chino, Chino, California, United States
Proscience Research Group, Culver City, California, United States
Collaborative Neuroscience Research, LLC, Garden Grove, California, United States
Omega Clinical Trials - La Habra, La Habra, California, United States
Catalina Research Institute, LLC, Montclair, California, United States
NRC Research Institute, Orange, California, United States
Clinical Innovations, Inc. dba CITrials, Riverside, California, United States

Bipolar I Disorder

Phase II study for patients with Bipolar 1 Disorder experiencing major depressive episode. Patient eligible for enrollme…

Bentonville, United StatesEst. completion Feb 2028

Bipolar Disorder Type I With Mania or Mania With Mixed Features

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipol…

Little Rock, United StatesEst. completion Nov 2, 2026

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