Bipolar-I Disorder With Mania or Mania With Mixed FeaturesPhase 3BALSAM-1NCT06951698
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
A Phase 3 study testing KarXT in people with Bipolar-I Disorder With Mania or Mania With Mixed Features, run by Bristol-Myers Squibb at 74 sites in 9 countries.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar-I Disorder 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
- 74 sitesin 9 countries
- Study dates
- 11 Jun 2025to 1 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 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.
Trial locations and contacts
74 sites in 9 countries. Contact the study team or a site near you to ask about taking part.
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com contact
First line of the email MUST contain NCT # and Site #. contact
74 sites in 9 countries
United States23 sites, 21 recruiting
- Recruiting
Advanced Research Center Inc.
Anaheim, California, 92805
Steven Macina, Site 0005, 714-999-6688
- Recruiting
Synexus Clinical Research US, Inc.
Atlanta, Georgia, 30328
Bethany Davis, Site 0009, 404-255-6005
- Recruiting
Community Clinical Research
Austin, Texas, 78754
David Brown, Site 0141, 512-323-2622
- Recruiting
CITrials
Bellflower, California, 90706
Gerald Maguire, Site 0008, 562-249-6956
- Active, not recruiting
Local Institution - 0058
Bentonville, Arkansas, 72712
- Not yet recruiting
Local Institution - 0014
Cerritos, California, 90703
Site 0014
- Recruiting
Pillar Clinical Research -Chicago
Chicago, Illinois, 60641
Roueen Rafeyan, Site 0047, 312-865-6336
- Recruiting
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
Edwin Gomez, Site 0043, 954-604-3900
- Recruiting
Advanced Research Institute of Miami
Homestead, Florida, 33033
Moraima Trujillo, Site 0020, 305-246-0001
- Withdrawn
Local Institution - 0029
Irving, Texas, 75062
- Recruiting
Woodland International Research Group
Little Rock, Arkansas, 72211
George Konis, Site 0011, 501-221-8681
- Recruiting
Collaborative Neuroscience Research, LLC
Long Beach, California, 90806
David Walling, Site 0059, 714-799-7799
- Recruiting
NRC Research Institute
Los Angeles, California, 90015
Tony Ortiz, Site 0053, 714-289-1100
- Recruiting
South Florida Research Phase I-IV
Miami, Florida, 33166
Silvia Silva Duluc, Site 0069, 305-669-6166
- Recruiting
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016
Rishi Kakar, Site 0054, 786-512-4106
- Not yet recruiting
Local Institution - 0015
Miami Lakes, Florida, 33016
Site 0015
- Recruiting
Catalina Research Institute, LLC
Montclair, California, 91763
Stephen Volk, Site 0072, 909-590-8409
- Recruiting
Connecticut Mental Health Center
New Haven, Connecticut, 06519
Deepak D'Souza, Site 0124, 20393257112594
- Recruiting
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720
Shishuka Malhotra, Site 0013, 330-493-1118
- Recruiting
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
Scott Bartley, Site 0044, 214-396-4844
- Recruiting
CenExel iResearch, LLC
Savannah, Georgia, 31405
Michael Mobley, Site 0057, 912-744-0800
- Recruiting
Richmond Behavioral Associates
Staten Island, New York, 10314
Peter Weiden, Site 0030, 917-701-7484
- Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
Mohammad Nisar, Site 0023, 786-831-7303
Japan19 sites, 15 recruiting
- Recruiting
Kuramitsu Hospital
Fukuoka, 819-0037
Noriko Tamaru, Site 0083, +81-92-811-1821
- Recruiting
National Kohnodai Medical Center.
Ichikawa, Chiba, 272-8516
Toshihiko Ito, Site 0078, +81-47-372-3501
- Withdrawn
Local Institution - 0081
Iruma, Saitama, 350-0495
- Recruiting
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, 847-0031
Taro Shindo, Site 0087, 0955770711
- Withdrawn
Local Institution - 0100
Kitakyushu, Fukuoka, 803-0831
- Recruiting
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551
Takamasa Noda, Site 0105, +81-42-341-2711
- Completed
Local Institution - 0082
Kōnan, Aichi-ken, 4838248
- Recruiting
Saitama Konan Hospital
Kumagaya, Saitama, 360-0114
Narifumi Yokoyama, Site 0092, 048-536-1366
- Recruiting
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, 880-8510
Jiro Kawano, Site 0077, 81985244181
- Recruiting
Kansai Medical University Medical Center
Moriguchi, Osaka, 570-8507
Masaki Kato, Site 0089, +81-6-6992-1001
- Recruiting
Obihiro Kosei Hospital
Obihiro, Hokkaido, 080-0024
Kengo Furuse, Site 0090, 81155650102
- Recruiting
Osaka Metropolitan University Hospital
Osaka, 545-8586
Yasuhiko Deguchi, Site 0086, +81-6-6645-3821
- Withdrawn
Local Institution - 0084
Osaka, 590-0018
- Recruiting
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, 002-8029
Kimihiro Nakajima, Site 0080, +81-11-771-5660
- Recruiting
Narimasu Kosei Hospital
tabashi City, Tokyo, 175-0091
Yuya Tenjin, Site 0085, 0339391191
- Recruiting
Showa Medical University Karasuyama Hospital
Tokyo, 157-8577
Kenji Sanada, Site 0104, +81-3-3300-5231
- Recruiting
Okehazama Hospital
Toyoake, Aichi-ken, 470-1168
kiyoshi Fujita, Site 0079, 0562971361
- Recruiting
Wakayama Medical University Hospital
Wakayama, 641-8510
Sohei Kimoto, Site 0076, 073-441-0659
- Recruiting
Yamagata Sakuracho Hospital
Yamagata, 990-0045
Nobuhiro Yokokawa, Site 0088, +81236312315
Bulgaria7 sites, 7 recruiting
- Recruiting
Center for Mental Health Prof. Dr. Ivan Temkov
Burgas, 8001
Veselin Palazov, Site 0113, 359888451225
- Not yet recruiting
Local Institution - 0139
Haskovo, 6300
Site 0139
- Not yet recruiting
Local Institution - 0138
Kazanlak, Stara Zagora, 6100
Site 0138
- Recruiting
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
Novi Iskar, 1282
Tsveteslava Galabova, Site 0119, 359892444643
- Recruiting
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, 5800
Maya Stoimenova - Popova, Site 0112, +359888227165
- Recruiting
MHAT "Dr. Ival Seliminski"
Sliven, 8800
Rozalina Petrova, Site 0120, 00359887801545
- Recruiting
Mental Health Center - Vratsa
Vratsa, 3000
Nadya Ivanova, Site 0121, +359887422440
Poland7 sites, 7 recruiting
- Recruiting
Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
Bialystok, Podlaskie Voivodeship, 15-272
Napoleon Waszkiewicz, Site 0094, +48608888796
- Not yet recruiting
Local Institution - 0111
Gdansk, Pomeranian Voivodeship, 80-214
Site 0111
- Recruiting
Centrum Medyczne HCP
Poznan, Greater Poland Voivodeship, 61-485
Sylwia Szymkowiak, Site 0095, +48604116632
- Recruiting
M2M Med
Rybnik, Silesian Voivodeship, 44-200
Wojciech Eysymontt, Site 0103, +48609673001
- Not yet recruiting
Local Institution - 0102
Sosnowiec, Silesian Voivodeship, 41-200
Site 0102
- Recruiting
Clinica Inventiva
Tuszyn, 95-080
Jaroslaw Strzelec, Site 0096, 602305132
- Recruiting
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, 02-957
Adam Wichniak, Site 0107, +48600-107-410
Ukraine7 sites, 7 recruiting
- Recruiting
MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
Dnipro, Dnipropetrovsk Oblast, 49115
Svitlana Moroz, Site 0130, +380675658914
- Recruiting
Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
Kropyvnytskyi, Kirovohrad Oblast, 25491
Yevhen Denysov, Site 0126, +380505641035
- Recruiting
CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)
Kyiv, 04080
Yuliya Blazhevych, Site 0129, +380503847048
- Recruiting
Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
Poltava, 36013
Andriy Skrypnikov, Site 0132, +380502523300
- Recruiting
Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
Skarzhyntsi, Khmelnytskyi Oblast, 32120
Viktoriia Kachynska, Site 0133, 380672624158
- Recruiting
Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"
Smila, 20708
Iryna Kosenkova, Site 0131, 380473321979
- Not yet recruiting
Local Institution - 0137
Ternopil, 46027
Site 0137
Argentina5 sites, 5 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
ABB, Buenos Aires F.D., C1199ABB
José Faccioli, Site 0110, +5491157934078
- Recruiting
Sanatorio Morra S.A.
Córdoba, 5000
Carlos Morra, Site 0115, 5493516858696
- Recruiting
Clinica del Prado
Las Heras, Mendoza Province, 5539
Eugenio Velasco, Site 0108, 54-261-9-155861633
- Not yet recruiting
Local Institution - 0109
Mendoza, 5502
Site 0109
- Not yet recruiting
Local Institution - 0140
Santiago del Estero, G4200DND
Site 0140
Hungary3 sites, 3 recruiting
- Recruiting
Semmelweis Egyetem
Budapest, 1083
János Réthelyi, Site 0118, +3612100336
- Recruiting
Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet
Budapest, 1135
Csaba Almasi, Site 0114, +36 30 604 9696
- Recruiting
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, 9024
Gabor Feller, Site 0116
Australia2 sites, 2 recruiting
- Recruiting
Ramsay Clinic New Farm
Brisbane, Queensland, 4005
James Scott, Site 0106, +61 7 3069 7398
- Recruiting
Ramsay Clinic Northside
St Leonards, New South Wales, 2065
Philip Mitchell, Site 0117, +61 2 9433 3555
New Zealand1 site, 1 recruiting
- Recruiting
North Shore Hospital
Auckland, 0622
Sylvester Miles, Site 0055, +6421963555
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-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
Read the 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.
- Being tested
- KarXT, Placebo
- Keywords
- Bipolar-I, Mania, Mixed
- 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, Trospium Chloride
Specified dose on specified days
PlaceboOther
Specified dose on specified days
| 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 a ≥ 50% decrease from baseline in YMRS total score
Measured: At week 3
Occurrence of response based on CGI-BP change from baseline ≥ 1
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.
- First posted30 Apr 2025
- Study start11 Jun 2025
- Primary completion1 Nov 2026 (estimated)
- Study completion1 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-I Disorder 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)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951698
- Sponsor's protocol ID
- CN012-0036
- Other IDs
- 2024-520165-32, U1111-1316-7438
- Acronym
- BALSAM-1
- Status last verified
- Oct 2026
- First submitted
- 23 Apr 2025
- Last updated
- 23 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