Bipolar Disorder Type I With Mania or Mania With Mixed FeaturesPhase 3NCT06951711

A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)

A Phase 3 study testing KarXT in people with Bipolar Disorder Type I With Mania or Mania With Mixed Features, run by Bristol-Myers Squibb at 85 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Bipolar Disorder Type I With Mania or Mania With Mixed Features
What is being tested?: KarXT
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 274 participants
Where: 85 sitesin 11 countries
Study dates: 13 Jun 2025to 2 Nov 2026
Phase: Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 cirrhosis, liver cancer, clinically significant liver disease based on the liver function test results.
Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

85 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact

855-907-3286

Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #. contact

Country

City, postcode or hospital

Sites recruiting now only

85 sites in 11 countries

United States28 sites, 22 recruiting

Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Elyssa Barron, Site 0022, 404-881-5800
Recruiting
Health Synergy Clinical Research
Boynton Beach, Florida, 33426
Mohammad Nisar, Site 0083, 786-831-7303
Recruiting
Local Institution - 0075
Charlotte, North Carolina, 28211
Withdrawn
Local Institution - 0020
Chicago, Illinois, 60640
Site 0020
Not yet recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Caleb Adler, Site 0029, 513-404-0279
Recruiting
Proscience Research Group
Culver City, California, 90230
Marina Bussel, Site 0021, 424-227-8127
Recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
Kimball Johnson, Site 0016, 404-537-1281
Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Rajinder Shiwach, Site 0012, 972-283-6286
Recruiting
Precise Research Centers
Flowood, Mississippi, 39232
Joseph Kwentus, Site 0017, 601-420-5810
Recruiting
CBH Health
Gaithersburg, Maryland, 20877
Elia Acevedo Diaz, Site 0024, 301-251-4702
Recruiting
Local Institution - 0036
Hialeah Gardens, Florida, 33016
Withdrawn
Behavioral Clinical Research
Hollywood, Florida, 33021
Olga Lapeyra, Site 0032, 954-375-7794
Recruiting
Local Institution - 0028
Houston, Texas, 77021
Withdrawn
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, 72204
Leslie Smith, Site 0014, 501-350-3285
Recruiting
Hassman Research Institute Marlton Site
Marlton, New Jersey, 08053
Elan Cohen, Site 0080, 267-981-8911
Recruiting
Local Institution - 0031
Marlton, New Jersey, 08053
Withdrawn
LCC Medical Research Institute
Miami, Florida, 33126
Yesenia Kuan, Site 0026, 305-400-0814
Recruiting
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016
Rishi Kakar, Site 0081, 786-512-4106
Recruiting
South Florida Research Phase I-IV
Miami Springs, Florida, 33166
Silvia Silva Duluc, Site 0015, 305-669-6166
Recruiting
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720
Shishuka Malhotra, Site 0038, 330-493-1118
Recruiting
Local Institution - 0076
North Las Vegas, Nevada, 89030
Withdrawn
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
Scott Bartley, Site 0037, 214-396-4844
Recruiting
Pillar Clinical Research
Richardson, Texas, 75080
Fayz Hudefi, Site 0095, 479-367-2688
Recruiting
Clinical Innovations, Inc. dba CITrials
Riverside, California, 92506
Evagelos Coskinas, Site 0018, 951300492
Recruiting
Woodland Research Northwest
Rogers, Arkansas, 72758
Robert Billingsley, Site 0025, 479-927-3000
Recruiting
Arch Clinical Trials
St Louis, Missouri, 63141
Junaid Syed, Site 0023, 314-771-6387
Recruiting
Local Institution - 0019
Tampa, Florida, 33618
Withdrawn
Collaborative Neuroscience Research, LLC
Torrance, California, 90502
Lara Shirikjian, Site 0074, 310-523-4200
Recruiting

Other trials in United States

Romania11 sites, 10 recruiting

Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Valentin Matei, Site 0048, +40721243869
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Corina Nicolae, Site 0059, +40727818190
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
SIMONA TRIFU, Site 0049, 0040731581100
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Mihnea Manea, Site 0060, 0040745974029
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
ADELA CIOBANU, Site 0050, 0040723671301
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Laura Cristina Dolis, Site 0062, 0040757243543
Recruiting
Institutul National de Gerontologie si Geriatrie "Ana Aslan" - Clinica Bucuresti
Bucharest, Bucharest, 11241
Traian Purnichi, Site 0097, +40749156565
Recruiting
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
Bucharest, 060222
Traian Barbu, Site 0064, +40723652564
Recruiting
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
Bucharest, 0
Octavian Vasiliu, Site 0057, 0040723725815
Recruiting
Local Institution - 0047
Iași, 700282
Withdrawn
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, 507190
Petru Ifteni, Site 0061, 0040724993329
Recruiting

Other trials in Romania

India8 sites, 8 recruiting

KLES Dr. Prabhakar Kore Hospital & M.R.C
Belagavi, Karnataka, 590010
Bheemsain Tekkalaki, Site 0082, +91-0831-2444040
Recruiting
Asha Hospital - Hyderabad
Hyderabad, Telangana, 500034
G Rao, Site 0052, 9985900005
Recruiting
Local Institution - 0055
Hyderabad, Telangana, 500082
Site 0055
Not yet recruiting
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014
Asish Mukhopadhyay, Site 0054, 8250737511
Recruiting
Chethana Center for Neuropsychiatry
Kozhikode, Kerala, 673009
SURESHKUMAR N, Site 0053, 9447218825
Recruiting
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001
Navkiran Mahajan, Site 0051, 9872655008
Recruiting
GMERS Medical College and General Hospital
Vadodara, Gujarat, 390021
Sandip Shah, Site 0065, 9824060683
Recruiting
Local Institution - 0099
Visakhapatnam, Andhra Pradesh, 530048
Site 0099
Not yet recruiting

Other trials in India

Ukraine7 sites, 7 recruiting

Local Institution - 0088
Dnipro, Dnipropetrovsk Oblast, 49115
Site 0088
Not yet recruiting
Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
Hlevakha, Kyiv Oblast, 08631
Gennadii Zilberblat, Site 0092, 380506480750
Recruiting
Local Institution - 0084
Kropyvnytskyi, Kirovohrad Oblast, 25491
Site 0084
Not yet recruiting
Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council
Odesa, 65006
Anatolii Voloshchuk, Site 0094, 38 0637356555
Recruiting
Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council
Oleksandrivka, Odesa Oblast, 67513
Yevgen Oprya, Site 0093, +380679920420
Recruiting
Local Institution - 0090
Poltava, 36013
Site 0090
Not yet recruiting
Communal non-profit enterprise "Vinnytsia Regional Clinical Psycho-Neurological Hospital n.a. acad. O.I. Yushchenko of VRC"
Vinnytsia, Vinnytsia Oblast, 21037
Oksana Serebrennikova, Site 0085, +380679605672
Recruiting

Other trials in Ukraine

China6 sites, 6 recruiting

Local Institution - 0103
Beijing, Beijing Municipality, 100088
Site 0103
Not yet recruiting
Local Institution - 0106
Beijing, Beijing Municipality, 100088
Site 0106
Not yet recruiting
Local Institution - 0107
Changsha, Hunan, 410007
Site 0107
Not yet recruiting
Local Institution - 0105
Jining Shi, Shandong, 272051
Site 0105
Not yet recruiting
Local Institution - 0104
Tianjin, Tianjin Municipality, 300022
Site 0104
Not yet recruiting
Local Institution - 0108
Wuhan, Hubei, 430012
Site 0108
Not yet recruiting

Other trials in China

Israel6 sites, 6 recruiting

Be'er Sheva Mental Health Center
Beersheba, Southern District, 8461144
Yuly Bersudsky, Site 0066, 972-8-6401463
Recruiting
Shalvata Mental Health Center
Hod HaSharon, Central District, 4534708
Yuri Fonar, Site 0042, +972545838725
Recruiting
Kfar Shaul Mental Health Center
Jerusalem, 9546105
Alexander Teitelbaum, Site 0045, +972-506262005
Recruiting
Ness Ziona Mental Health Center
Ness Ziona, Central District, 7410001
Marina Kupchik, Site 0046, +972506261093
Recruiting
Local Institution - 0058
Petah Tikva, Central District, 4910002
Site 0058
Not yet recruiting
Sheba Medical Center
Ramat Gan, Central District, 5265601
Linda Levi-Haramati, Site 0011, 0585950299
Recruiting

Other trials in Israel

Croatia5 sites, 4 recruiting

Local Institution - 0009
Zagreb, City of Zagreb, 10090
Withdrawn
Klinika za psihijatriju "Vrapče"
Zagreb, 10090
Miroslav Herceg, Site 0008, 3853780732
Recruiting
Klinika za psihijatriju "Vrapče"
Zagreb, 10090
Ninoslav Mimica, Site 0063, +38513780678
Recruiting
Klinika za psihijatriju "Vrapče"
Zagreb, 10090
Marko Curkovic, Site 0078, 385951648446
Recruiting
Psihijatrijska bolnica "Sveti Ivan"
Zagreb, 10090
Igor Filipcic, Site 0010, 38513430020
Recruiting

Other trials in Croatia

Italy5 sites

Local Institution - 0041
Ancona, 60126
Withdrawn
Local Institution - 0040
Genova, 16132
Withdrawn
Local Institution - 0001
Milan, Lombardy, 20122
Withdrawn
Local Institution - 0056
Pisa, Tuscany, 56126
Withdrawn
Local Institution - 0007
Siena, Tuscany, 53100
Withdrawn

Other trials in Italy

Slovakia3 sites, 3 recruiting

EPAMED - Košice - Hlavná
Košice, Košice Region, 040 01
Eva Palova, Site 0073, 00421902539617
Recruiting
Univerzitna Nemocnica L. Pasteura Kosice
Košice, Košice Region, 040 01
Slavka Dubinska, Site 0071, +421903625643
Recruiting
Crystal Comfort
Vranov nad Topľou, Presov, 093 01
Dagmar Breznoscakova, Site 0072
Recruiting

Other trials in Slovakia

Spain3 sites

Local Institution - 0069
Barcelona, Barcelona [Barcelona], 08035
Completed
Local Institution - 0044
Barcelona, Catalunya [Cataluña], 08036
Completed
Local Institution - 0039
Bilbao, Basque Country, 48013
Completed

Other trials in Spain

Sweden3 sites

Local Institution - 0070
Gothenburg, Västra Götalands Län [se-14], 413 45
Withdrawn
Local Institution - 0077
Nacka, Stockholms Län [se-01], 131 45
Completed
Local Institution - 0067
Uppsala, Uppsala Län [se-03], 751 85
Withdrawn

Other trials in Sweden

About this study

Official title: 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-2)

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.

Conditions: Bipolar Disorder Type I With Mania or Mania With Mixed Features
Being tested: KarXT, Placebo
Keywords: Bipolar-I disorder, Mania, Bipolar-I disorder with Mania
Medical subject headings: Mania

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KarXTDrug
Also called BMS-986510, Xanomeline and trospium chloride
Specified dose on specified days
PlaceboOther
Specified dose on specified days

Study groups in NCT06951711
Study group	Role	What they receive
KarXT	Experimental	Flexible dosing Receives: Drug: KarXT
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from baseline in Young Mania Rating Scale (YMRS) score
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.
Measured: At week 3

Secondary outcomes (3)

Change from baseline in Clinical Global Impressions-Bipolar (CGI-BP)
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).
Measured: At week 3
Occurrence of response based on ≥ 50% decrease from baseline in YMRS score or total score
Measured: At week 3
Occurrence of response based on change from baseline ≥ 1 in CGI-BP
Measured: At week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jun 20252 Nov 2026

First posted30 Apr 2025
Study start13 Jun 2025
Primary completion2 Nov 2026 (estimated)
Study completion2 Nov 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bipolar Disorder Type I With Mania or Mania With Mixed FeaturesStudies of the same condition, open and under way.
More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 274 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06951711
Sponsor's protocol ID: CN012-0037
Other IDs: 2024-520195-94, U1111-1316-7466
Status last verified: Oct 2026
First submitted: 23 Apr 2025
Last updated: 20 Oct 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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