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
Local Institution - 0059
NOT_YET_RECRUITING
Long Beach
Local Institution - 0072
NOT_YET_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
Local Institution - 0057
NOT_YET_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WITHDRAWN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
Local Institution - 0113
NOT_YET_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
Local Institution - 0118
NOT_YET_RECRUITING
Budapest
Local Institution - 0116
NOT_YET_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
Local Institution - 0105
NOT_YET_RECRUITING
Kodaira
Local Institution - 0082
NOT_YET_RECRUITING
Kōnan
Saitama Konan Hospital
RECRUITING
Kumagaya
Local Institution - 0077
NOT_YET_RECRUITING
Miyazaki
Obihiro Kosei Hospital
RECRUITING
Obihiro
Local Institution - 0084
NOT_YET_RECRUITING
Osaka
Local Institution - 0086
NOT_YET_RECRUITING
Osaka
Local Institution - 0089
NOT_YET_RECRUITING
Osaka
Local Institution - 0080
NOT_YET_RECRUITING
Sapporo
Narimasu Kosei Hospital
RECRUITING
Tabashi City
Showa Medical University Karasuyama Hospital
RECRUITING
Tokyo
Local Institution - 0079
NOT_YET_RECRUITING
Toyoake
Local Institution - 0076
NOT_YET_RECRUITING
Wakayama
Local Institution - 0088
NOT_YET_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