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)
Status: Recruiting
Location: See all (63) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Participants must have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation.
• Participants must be experiencing an acute episode or relapse of mania or mania with mixed features (≤ 3 weeks).
• Participants must require hospitalization for the acute exacerbation or relapse of mania.
• Participants must have all psychotropic medications washed out in no more than 14 days prior to the first dose of the study drug.
• Participants must have a Young Mania Rating Scale (YMRS) score of ≥ 20 at Screening and at Baseline.
• Participants must have a Clinical Global Impressions-Bipolar (CGI-BP) ≥ 4 at Screening and at Baseline.
Locations
United States
Arkansas
Pillar Clinical Research - Bentonville
RECRUITING
Bentonville
Woodland International Research Group
RECRUITING
Little Rock
California
Advanced Research Center Inc.
RECRUITING
Anaheim
CITrials
RECRUITING
Bellflower
Local Institution - 0014
NOT_YET_RECRUITING
Cerritos
Collaborative Neuroscience Research, LLC
RECRUITING
Long Beach
Catalina Research Institute, LLC
RECRUITING
Montclair
NRC Research Institute
RECRUITING
Orange
Connecticut
Local Institution - 0124
NOT_YET_RECRUITING
New Haven
Florida
Health Synergy Clinical Research
RECRUITING
Boynton Beach
Research Centers of America ( Hollywood )
RECRUITING
Hollywood
Advanced Research Institute of Miami
RECRUITING
Homestead
Innovative Clinical Research, Inc.
RECRUITING
Miami Lakes
Local Institution - 0015
NOT_YET_RECRUITING
Miami Lakes
South Florida Research Phase I-IV
RECRUITING
Miami Springs
Georgia
Synexus Clinical Research US, Inc.
RECRUITING
Atlanta
CenExel iResearch, LLC
RECRUITING
Savannah
Illinois
Pillar Clinical Research -Chicago
RECRUITING
Chicago
New York
Richmond Behavioral Associates
RECRUITING
Staten Island
Ohio
Neuro-Behavioral Clinical Research
RECRUITING
North Canton
Texas
Local Institution - 0029
WITHDRAWN
Irving
Pillar Clinical Research - Richardson
RECRUITING
Richardson
Other Locations
Argentina
Local Institution - 0110
NOT_YET_RECRUITING
Abb
Local Institution - 0115
NOT_YET_RECRUITING
Córdoba
Local Institution - 0108
NOT_YET_RECRUITING
Mendoza
Local Institution - 0109
NOT_YET_RECRUITING
Mendoza
Australia
Ramsay Clinic New Farm
RECRUITING
Brisbane
Ramsay Clinic Northside
RECRUITING
St Leonards
Bulgaria
Center for Mental Health Prof. Dr. Ivan Temkov
RECRUITING
Burgas
Local Institution - 0119
NOT_YET_RECRUITING
Novi Iskar
Local Institution - 0112
NOT_YET_RECRUITING
Pleven
Local Institution - 0120
NOT_YET_RECRUITING
Sliven
Local Institution - 0121
NOT_YET_RECRUITING
Vratsa
Hungary
Local Institution - 0114
NOT_YET_RECRUITING
Budapest
Semmelweis Egyetem
RECRUITING
Budapest
Petz Aladar Egyetemi Oktato Korhaz
RECRUITING
Győr
Japan
Kuramitsu Hospital
RECRUITING
Fukuoka
National Kohnodai Medical Center.
RECRUITING
Ichikawa
Local Institution - 0081
WITHDRAWN
Iruma
Rainbow and Sea Hospital
RECRUITING
Karatsu-shi
Local Institution - 0100
WITHDRAWN
Kitakyushu
National Center of Neurology and Psychiatry
RECRUITING
Kodaira
Local Institution - 0082
NOT_YET_RECRUITING
Kōnan
Saitama Konan Hospital
RECRUITING
Kumagaya
Local Institution - 0077
NOT_YET_RECRUITING
Miyazaki
Kansai Medical University Medical Center
RECRUITING
Moriguchi
Obihiro Kosei Hospital
RECRUITING
Obihiro
Local Institution - 0084
NOT_YET_RECRUITING
Osaka
Osaka Metropolitan University Hospital
RECRUITING
Osaka
Goryokai Medical Corporation - Goryokai Hospital
RECRUITING
Sapporo
Narimasu Kosei Hospital
RECRUITING
Tabashi City
Showa Medical University Karasuyama Hospital
RECRUITING
Tokyo
Okehazama Hospital
RECRUITING
Toyoake
Wakayama Medical University Hospital
RECRUITING
Wakayama
Yamagata Sakuracho Hospital
RECRUITING
Yamagata
New Zealand
Local Institution - 0055
NOT_YET_RECRUITING
Auckland
Poland
Local Institution - 0094
NOT_YET_RECRUITING
Bialystok
Local Institution - 0111
NOT_YET_RECRUITING
Gdansk
Local Institution - 0095
NOT_YET_RECRUITING
Poznan
Local Institution - 0103
NOT_YET_RECRUITING
Rybnik
Local Institution - 0102
NOT_YET_RECRUITING
Sosnowiec
Local Institution - 0096
NOT_YET_RECRUITING
Tuszyn
Local Institution - 0107
NOT_YET_RECRUITING
Warsaw
Contact Information
Primary
BMS Study Connect www.BMSStudyConnect.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain the NCT# and Site#
Time Frame
Start Date: 2025-06-11
Estimated Completion Date: 2026-11-01
Participants
Target number of participants: 274
Treatments
Experimental: KarXT
Flexible dosing
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb