A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-1)

April 13, 2026 updated by: Bristol-Myers Squibb

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)

The purpose of this study is to evaluate the efficacy and safety of KarXT for the treatment of manic episodes in Bipolar-I Disorder

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in subjects with bipolar disorder experiencing an acute episode of mania or mania with mixed features.

The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.

Study Type

Interventional

Enrollment (Estimated)

274

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: First line of the email MUST contain NCT # and Site #.

Study Contact Backup

  • Name: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
  • Phone Number: 855-907-3286
  • Email: Clinical.Trials@bms.com

Study Locations

  • Argentina
      • Córdoba, Argentina, 5000
        • Recruiting
        • Sanatorio Morra S.A.
        • Contact:
          • Carlos Morra, Site 0115
          • Phone Number: 5493516858696
      • Mendoza, Argentina, 5502
        • Not yet recruiting
        • Local Institution - 0108
        • Contact:
          • Site 0108
      • Mendoza, Argentina, 5502
        • Not yet recruiting
        • Local Institution - 0109
        • Contact:
          • Site 0109
    • Buenos Aires F.D.
      • ABB, Buenos Aires F.D., Argentina, C1199ABB
        • Recruiting
        • Hospital Italiano de Buenos Aires
        • Contact:
          • José Faccioli, Site 0110
          • Phone Number: +5491157934078
  • Australia
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Ramsay Clinic Northside
        • Contact:
          • Philip Mitchell, Site 0117
          • Phone Number: +61 2 9433 3555
    • Queensland
      • Brisbane, Queensland, Australia, 4005
        • Recruiting
        • Ramsay Clinic New Farm
        • Contact:
          • James Scott, Site 0106
          • Phone Number: +61 1300 290 645
  • Bulgaria
      • Burgas, Bulgaria, 8001
        • Recruiting
        • Center for Mental Health Prof. Dr. Ivan Temkov
        • Contact:
          • Veselin Palazov, Site 0113
          • Phone Number: 359888451225
      • Novi Iskar, Bulgaria, 1282
        • Recruiting
        • State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
        • Contact:
          • Tsveteslava Galabova, Site 0119
          • Phone Number: 359892444643
      • Pleven, Bulgaria, 5800
        • Recruiting
        • "University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
        • Contact:
          • Maya Stoimenova - Popova, Site 0112
          • Phone Number: +359888227165
      • Sliven, Bulgaria, 8800
        • Recruiting
        • MHAT "Dr. Ival Seliminski"
        • Contact:
          • Rozalina Petrova, Site 0120
          • Phone Number: 00359887801545
      • Vratsa, Bulgaria, 3000
        • Recruiting
        • Mental Health Center - Vratsa
        • Contact:
          • Nadya Ivanova, Site 0121
          • Phone Number: +359887422440
  • Hungary
      • Budapest, Hungary, 1083
        • Recruiting
        • Semmelweis Egyetem
        • Contact:
          • János Réthelyi, Site 0118
          • Phone Number: +3612100336
      • Budapest, Hungary
        • Not yet recruiting
        • Local Institution - 0114
        • Contact:
          • Site 0114
    • Győr-Moson-Sopron
      • Győr, Győr-Moson-Sopron, Hungary, 9024
        • Recruiting
        • Petz Aladar Egyetemi Oktato Korhaz
        • Contact:
          • Gabor Feller, Site 0116
  • Japan
      • Fukuoka, Japan, 819-0037
        • Recruiting
        • Kuramitsu Hospital
        • Contact:
          • Noriko Tamaru, Site 0083
          • Phone Number: +81-92-811-1821
      • Miyazaki, Japan, 880-8510
        • Recruiting
        • Miyazaki Prefectural Miyazaki Hospital
        • Contact:
          • Jiro Kawano, Site 0077
          • Phone Number: 81985244181
      • Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital
        • Contact:
          • Yasuhiko Deguchi, Site 0086
          • Phone Number: +81-6-6645-3821
      • Osaka, Japan, 590-0018
        • Not yet recruiting
        • Local Institution - 0084
        • Contact:
          • Site 0084
      • Tokyo, Japan, 157-8577
        • Recruiting
        • Showa Medical University Karasuyama Hospital
        • Contact:
          • Kenji Sanada, Site 0104
          • Phone Number: +81-3-3300-5231
      • Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital
        • Contact:
          • Sohei Kimoto, Site 0076
          • Phone Number: 073-441-0659
      • Yamagata, Japan, 990-0045
        • Recruiting
        • Yamagata Sakuracho Hospital
        • Contact:
          • Nobuhiro Yokokawa, Site 0088
          • Phone Number: +81236312315
    • Aichi-ken
      • Kōnan, Aichi-ken, Japan, 4838248
        • Recruiting
        • Hotei Hospital
        • Contact:
          • Takakura Masashi, Site 0082
          • Phone Number: +81587557251
      • Toyoake, Aichi-ken, Japan, 470-1168
        • Recruiting
        • Okehazama Hospital
        • Contact:
          • kiyoshi Fujita, Site 0079
          • Phone Number: 0562971361
    • Chiba
      • Ichikawa, Chiba, Japan, 272-8516
        • Recruiting
        • National Kohnodai Medical Center.
        • Contact:
          • Toshihiko Ito, Site 0078
          • Phone Number: +81-47-372-3501
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 803-0831
        • Withdrawn
        • Local Institution - 0100
    • Hokkaido
      • Obihiro, Hokkaido, Japan, 080-0024
        • Recruiting
        • Obihiro Kosei Hospital
        • Contact:
          • Kengo Furuse, Site 0090
          • Phone Number: 81155650102
      • Sapporo, Hokkaido, Japan, 002-8029
        • Recruiting
        • Goryokai Medical Corporation - Goryokai Hospital
        • Contact:
          • Kimihiro Nakajima, Site 0080
          • Phone Number: +81-11-771-5660
    • Osaka
      • Moriguchi, Osaka, Japan, 570-8507
        • Recruiting
        • Kansai Medical University Medical Center
        • Contact:
          • Masaki Kato, Site 0089
          • Phone Number: +81-6-6992-1001
    • Saga-ken
      • Karatsu-shi, Saga-ken, Japan, 847-0031
        • Recruiting
        • Rainbow and Sea Hospital
        • Contact:
          • Taro Shindo, Site 0087
          • Phone Number: 0955770711
    • Saitama
      • Iruma, Saitama, Japan, 350-0495
        • Withdrawn
        • Local Institution - 0081
      • Kumagaya, Saitama, Japan, 360-0114
        • Recruiting
        • Saitama Konan Hospital
        • Contact:
          • Narifumi Yokoyama, Site 0092
          • Phone Number: 048-536-1366
    • Tokyo
      • Kodaira, Tokyo, Japan, 187-8551
        • Recruiting
        • National Center of Neurology and Psychiatry
        • Contact:
          • Takamasa Noda, Site 0105
          • Phone Number: +81-42-341-2711
      • tabashi City, Tokyo, Japan, 175-0091
        • Recruiting
        • Narimasu Kosei Hospital
        • Contact:
          • Yuya Tenjin, Site 0085
          • Phone Number: 0339391191
  • New Zealand
      • Auckland, New Zealand, 0622
        • Recruiting
        • North Shore Hospital
        • Contact:
          • Sylvester Miles, Site 0055
          • Phone Number: +6421963555
  • Poland
      • Tuszyn, Poland, 95-080
        • Recruiting
        • Clinica Inventiva
        • Contact:
          • Jaroslaw Strzelec, Site 0096
          • Phone Number: 602305132
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-485
        • Recruiting
        • Centrum Medyczne HCP
        • Contact:
          • Sylwia Szymkowiak, Site 0095
          • Phone Number: +48604116632
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-957
        • Recruiting
        • Instytut Psychiatrii i Neurologii
        • Contact:
          • Adam Wichniak, Site 0107
          • Phone Number: +48600-107-410
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-272
        • Recruiting
        • Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
        • Contact:
          • Napoleon Waszkiewicz, Site 0094
          • Phone Number: +48608888796
    • Pomeranian Voivodeship
      • Gdansk, Pomeranian Voivodeship, Poland, 80-214
        • Not yet recruiting
        • Local Institution - 0111
        • Contact:
          • Site 0111
    • Silesian Voivodeship
      • Rybnik, Silesian Voivodeship, Poland, 44-200
        • Recruiting
        • M2M Med
        • Contact:
          • Wojciech Eysymontt, Site 0103
          • Phone Number: +48609673001
      • Sosnowiec, Silesian Voivodeship, Poland, 41-200
        • Not yet recruiting
        • Local Institution - 0102
        • Contact:
          • Site 0102
  • United States
    • Arkansas
      • Bentonville, Arkansas, United States, 72712
        • Recruiting
        • Pillar Clinical Research - Bentonville
        • Contact:
          • Fayz Hudefi, Site 0058
          • Phone Number: 479-367-2688
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Woodland International Research Group
        • Contact:
          • George Konis, Site 0011
          • Phone Number: 501-221-8681
    • California
      • Anaheim, California, United States, 92805
        • Recruiting
        • Advanced Research Center Inc.
        • Contact:
          • Steven Macina, Site 0005
          • Phone Number: 714-999-6688
      • Bellflower, California, United States, 90706
        • Recruiting
        • CiTrials
        • Contact:
          • Robert Bota, Site 0008
          • Phone Number: 562-748-4999
      • Cerritos, California, United States, 90703
        • Not yet recruiting
        • Local Institution - 0014
        • Contact:
          • Site 0014
      • Long Beach, California, United States, 90806
        • Recruiting
        • Collaborative Neuroscience Research, LLC
        • Contact:
          • David Walling, Site 0059
          • Phone Number: 714-799-7799
      • Montclair, California, United States, 91763
        • Recruiting
        • Catalina Research Institute, LLC
        • Contact:
          • Stephen Volk, Site 0072
          • Phone Number: 909-590-8409
      • Orange, California, United States, 92868
        • Recruiting
        • NRC Research Institute
        • Contact:
          • Tony Ortiz, Site 0053
          • Phone Number: 714-289-1100
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Recruiting
        • Connecticut Mental Health Center
        • Contact:
          • Deepak D'Souza, Site 0124
          • Phone Number: 20393257112594
    • Florida
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Research Centers of America ( Hollywood )
        • Contact:
          • Edwin Gomez, Site 0043
          • Phone Number: 954-604-3900
      • Homestead, Florida, United States, 33033
        • Recruiting
        • Advanced Research Institute of Miami
        • Contact:
          • Moraima Trujillo, Site 0020
          • Phone Number: 305-246-0001
      • Miami, Florida, United States, 33166
        • Recruiting
        • South Florida Research Phase I-IV
        • Contact:
          • Silvia Silva Duluc, Site 0069
          • Phone Number: 305-669-6166
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Innovative Clinical Research, Inc.
        • Contact:
          • Rishi Kakar, Site 0054
          • Phone Number: 786-512-4106
      • Miami Lakes, Florida, United States, 33016
        • Not yet recruiting
        • Local Institution - 0015
        • Contact:
          • Site 0015
      • West Palm Beach, Florida, United States, 33407
        • Recruiting
        • Health Synergy Clinical Research
        • Contact:
          • Mohammad Nisar, Site 0023
          • Phone Number: 786-831-7303
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Recruiting
        • Synexus Clinical Research US, Inc.
        • Contact:
          • Bethany Davis, Site 0009
          • Phone Number: 404-255-6005
      • Savannah, Georgia, United States, 31405
        • Recruiting
        • CenExel iResearch, LLC
        • Contact:
          • Michael Mobley, Site 0057
          • Phone Number: 912-744-0800
    • Illinois
      • Chicago, Illinois, United States, 60641
        • Recruiting
        • Pillar Clinical Research -Chicago
        • Contact:
          • Roueen Rafeyan, Site 0047
          • Phone Number: 312-865-6336
    • New York
      • Staten Island, New York, United States, 10314
        • Recruiting
        • Richmond Behavioral Associates
        • Contact:
          • Peter Weiden, Site 0030
          • Phone Number: 917-701-7484
    • Ohio
      • North Canton, Ohio, United States, 44720
        • Recruiting
        • Neuro-Behavioral Clinical Research
        • Contact:
          • Shishuka Malhotra, Site 0013
          • Phone Number: 330-493-1118
    • Texas
      • Irving, Texas, United States, 75062
        • Withdrawn
        • Local Institution - 0029
      • Richardson, Texas, United States, 75080
        • Recruiting
        • Pillar Clinical Research - Richardson
        • Contact:
          • Scott Bartley, Site 0044
          • Phone Number: 214-396-4844

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

  • 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.

Exclusion Criteria:

  • Participants must not have any primary Diagnostic and Statistical Manual of Mental Disorders (5th Edition, Text Revision) (DSM-5-TR) disorder, other than BP-I with mania or mania with mixed features within 12 months before screening, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, with the exception of mild anxiety disorders.
  • Participants must not have a primary diagnosis of BP-I with rapid cycling (≥ 4 distinct mood episodes in one year).
  • Participants must not have a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening, or current use as determined by urine toxicology screen or alcohol test.
  • Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
  • Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
  • Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
  • Other protocol-defined Inclusion/Exclusion criteria apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Other: Placebo
Specified dose on specified days
Experimental: KarXT
Flexible dosing
Drug: KarXT
Specified dose on specified days
Other Names:
  • BMS-986510
  • Xanomeline
  • Trospium Chloride

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Young Mania Rating Scale (YMRS) score
Time Frame: At week 3
The YMRS comprised of 11 items that assess the severity of manic symptoms. All items are given a severity rating, with 4 items graded from 0 to 8 (irritability, speech, thought content, and disruptive/aggressive behavior), and the remaining 7 items are graded from 0 to 4 points. The highest score obtainable on the YMRS is 60 and the higher the number the greater the number of symptoms and/or the greater their severity.
At week 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP)
Time Frame: At week 3
The CGI-BP is designed to assess the severity, improvement, and efficacy of treatment in individuals with bipolar disorder. Only section I, illness severity, will be used, which includes three components: mania, depression, and overall bipolar illness. The ratings are on a 7-point scale (1 = normal, not ill; 2 = minimally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = very severely ill)
At week 3
Occurrence of response based on CGI-BP change from baseline ≥ 1
Time Frame: At week 3
At week 3
Occurrence of response based on a ≥ 50% decrease from baseline in YMRS total score
Time Frame: At week 3
At week 3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 11, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

April 23, 2025

First Submitted That Met QC Criteria

April 23, 2025

First Posted (Actual)

April 30, 2025

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 13, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN012-0036
  • 2024-520165-32 (Other Identifier: EU CTR)
  • U1111-1316-7438 (Other Identifier: WHO)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

BMS will provide access to individual anonymized participant data upon request from qualified researchers, and subject to certain criteria. Additional information regarding Bristol Myer Squibb's data sharing policy and process can be found at https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html

IPD Sharing Time Frame

See Plan Description

IPD Sharing Access Criteria

See Plan Description

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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