ManiaPhase 3NCT07140913

A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

A Phase 3 study testing Xanomeline/Trospium Chloride in people with Mania and Bipolar Disorder, run by Bristol-Myers Squibb at 109 sites in 13 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

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Mania, Bipolar Disorder
What is being tested?: Xanomeline/Trospium Chloride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 424 participants
Where: 109 sitesin 13 countries
Study dates: 8 Oct 2025to 28 Jun 2027
Phase: Phase 3
Are there results?: Not yet: the study is under way

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

Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2.
Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).
The individual requires hospitalization for the acute exacerbation or relapse of mania.
Body mass index ≥ 18 and ≤ 40 kg/m2.
Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.
YMRS Total Score of ≥ 18 at Screening and at Baseline, and < 20% reduction in YMRS from screening to baseline.

Who cannot join

Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders.
Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test.
Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or "Yes" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline.
History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.
History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.
Participants with HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections based on either medical history or the LFT results.

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Elevations in hepatic transaminases at screening ≥ 2 × ULN for ALT or AST and/or bilirubin > 1.5× ULN, unless in the context of Gilbert's syndrome.
All grades of hepatic impairment (mild [Child-Pugh Class A], moderate [Child-Pugh Class B], and severe [Child-Pugh Class C]).
Other protocol-defined Inclusion/Exclusion criteria apply.

Trial locations and contacts

109 sites in 13 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

109 sites in 13 countries

United States22 sites, 20 recruiting

Community Clinical Research
Austin, Texas, 78754
David Brown, Site 0026, 512-323-2622
Recruiting
Clinical Innovations, Inc. dba CITrials
Bellflower, California, 90706
Gerald Maguire, Site 0110, 562-249-6956
Recruiting
Pillar Clinical Research - Bentonville
Bentonville, Arkansas, 72712
Fayz Hudefi, Site 0029, 479-367-2688
Recruiting
Health Synergy Clinical Research
Boynton Beach, Florida, 33426
Mohammad Nisar, Site 0016, 786-831-7303
Recruiting
Pillar Clinical Research -Chicago
Chicago, Illinois, 60641
Roueen Rafeyan, Site 0017, 312-865-6336
Recruiting
Inland Psychiatric Medical Group.
Chino, California, 91710
Nandita Puchakayala, Site 0049, 909-488-9116
Recruiting
Proscience Research Group
Culver City, California, 90230
Marina Bussel, Site 0014, 424-227-8127
Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Rajinder Shiwach, Site 0034
Recruiting
Local Institution - 0015
Hallandale, Florida, 33009
Active, not recruiting
Elevate Clinical Research-Houston
Houston, Texas, 77058
Matthew Brams, Site 0160
Recruiting
Local Institution - 0209
Indianapolis, Indiana, 46202
Site 0209
Not yet recruiting
Omega Clinical Trials - La Habra
La Habra, California, 90631
Wakelin McNeel, Site 0151, 562-690-2200
Recruiting
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, 72204
Leslie Smith, Site 0018, 501-350-3285
Recruiting
Prime Clinical Research - Mansfield
Mansfield, Texas, 76063
Jamie Alexander, Site 0156, 817-907-7330
Recruiting
Local Institution - 0021
Miami, Florida, 33166
Active, not recruiting
Catalina Research Institute, LLC
Montclair, California, 91763
Stephen Volk, Site 0037, 909-590-8409
Recruiting
NRC Research Institute
Orange, California, 92868
Tony Ortiz, Site 0148, 714-289-1100
Recruiting
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
Scott Bartley, Site 0033, 214-396-4844
Recruiting
Clinical Innovations, Inc. dba CITrials
Riverside, California, 92506
Evagelos Coskinas, Site 0106, 951-300-4924
Recruiting
CenExel iResearch, LLC
Savannah, Georgia, 31405
Yael Elfassy, Site 0136, 912-744-0800
Recruiting
Arch Clinical Trials
St Louis, Missouri, 63141
Junaid Syed, Site 0023, 314-771-6387
Recruiting
Richmond Behavioral Associates
Staten Island, New York, 10314
Romana Kulikova, Site 0032, 718-619-4403
Recruiting

Other trials in United States

Japan14 sites, 12 recruiting

Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Tadafumi Kato, Site 0180, +81-(0)3-3813-3111
Recruiting
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 1138603
Amane Tateno, Site 0139, +81-3-3822-2131
Recruiting
Kuramitsu Hospital
Fukuoka, 819-0037
Noriko Tamaru, Site 0174, +81-92-811-1821
Recruiting
Local Institution - 0205
Ichikawa, Chiba, 272-8516
Site 0205
Not yet recruiting
Local Institution - 0172
Iizuka, Fukuoka, 820-8505
Withdrawn
Rainbow and Sea Hospital
Karatsu, Saga-ken, 847-0031
Taro Shindo, Site 0175, 0955770711
Recruiting
Local Institution - 0141
Kitakyushu-shi, Fukuoka, 8078555
Withdrawn
Kochi Health Sciences Center
Kochi, 781-8555
Ken Sawada, Site 0142, +81-88-837-3000
Recruiting
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551
Takamasa Noda, Site 0201, +81-42-341-2711
Recruiting
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, 002-8029
Kimihiro Nakajima, Site 0108, +81-11-771-5660
Recruiting
Narimasu Kosei Hospital
tabashi City, Tokyo, 175-0091
Yuya Tenjin, Site 0176, 0339391191
Recruiting
Okehazama Hospital
Toyoake, Aichi-ken, 470-1168
kiyoshi Fujita, Site 0173, 0562971361
Recruiting
Wakayama Medical University Hospital
Wakayama, 641-8510
Sohei Kimoto, Site 0204, 073-441-0659
Recruiting
Hino Hospital - Yokohama
Yokohama, Kanagawa, 234-0051
Atsuomi Baba, Site 0107, +81-45-843-8511
Recruiting

Other trials in Japan

Ukraine12 sites, 12 recruiting

MUNICIPAL NON-COMMERCIAL COMPANY Dnipropetrovsk Multiprofile Clinical Hospital for Provision of Psychiatric Care DRC
Dnipro, Dnipropetrovsk Oblast, 49115
Svitlana Moroz, Site 0165, +380675658914
Recruiting
Communal non-commercial enterprise of the Kyiv Regional Council "Regional Psychiatric-Narcological Medical Association"
Hlevakha, Kyiv Oblast, 08631
Gennadii Zilberblat, Site 0169, 380506480750
Recruiting
Communal Non-Commercial Enterprise "Regional Clinical Psychiatric Hospital of the Kirovohrad Regional Council
Kropyvnytskyi, 25491
Yevhen Denysov, Site 0163, +380505641035
Recruiting
CNCE "Clinical Facility for Mental Health Care "PSYCHIATRY" of executive body of Kyiv City Council (KCSA)
Kyiv, 04080
Yuliya Blazhevych, Site 0162, +380503847048
Recruiting
COMMUNAL NONCOMMERCIAL ENTERPRISE of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
Lviv, Lviv Oblast, 79021
Yuriy Filts, Site 0164, 380676702827
Recruiting
Local Institution - 0171
Odesa, Odesa Oblast, 67513
Site 0171
Not yet recruiting
Municipal Non-Commercial Enterprise "Odesa Regional Medical Centre of Mental Health" of Odesa Regional Council
Oleksandrivka, Odesa Oblast, 67513
Yevgen Oprya, Site 0170, +380679920420
Recruiting
Communal Enterprise "Regional Institution of Mental Psychiatric Care of the Poltava Regional Council"
Poltava, 36013
Andriy Skrypnikov, Site 0177, +380502523300
Recruiting
Municipal Non-Commercial Enterprise "Khmelnytskyi Regional Psychiatric Care Facility" of the Khmelnytskyi Regional Council
Skarzhyntsi, Khmelnytskyi Oblast, 32120
Viktoriia Kachynska, Site 0178, 380672624158
Recruiting
Communal non-commercial enterprise "Cherkasy regional psychiatric hospital of Cherkasy regional council"
Smila, 20708
Iryna Kosenkova, Site 0167, 380473321979
Recruiting
Local Institution - 0206
Ternopil, 46027
Site 0206
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 0168, +380679605672
Recruiting

Other trials in Ukraine

China11 sites, 10 recruiting

Hebei Mental Health Center
Baoding, Hebei, 071000
Yunshu Zhang, Site 0193, 15533222271
Recruiting
Beijing Anding Hospital - Affiliated Capital University of Medical Science
Beijing, Beijing Municipality, 100088
Qian Zhao, Site 0185, 13811953687
Recruiting
Beijing HuiLongGuan Hospital
Beijing, Beijing Municipality, 100096
Yunlong Tan, Site 0190, 010-83024302
Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Lehua Li, Site 0195, 13787186559
Recruiting
The Fourth People's Hospital of Chengdu
Chengdu, Sichuan, 610036
Feiyan Wang, Site 0192, 13408419080
Recruiting
Guangzhou Brain Hospital
Guangzhou, Guangdong, 510370
Xuan Li, Site 0191, 13902296157
Recruiting
Nanjing Brain Hospital
Nanjing, Jiangsu, 210029
zhijian yao, Site 0196
Recruiting
The Affilicated Kangning Hospital of Ningbo University
Ningbo, Zhejiang, 315201
Yongming Xu, Site 0197, 13655743461
Recruiting
Local Institution - 0187
Shijiazhuang, Hebei, 050031
Withdrawn
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300022
Lina Wang, Site 0188, 13821577556
Recruiting
Xi An Mental Health Center
Xi'an, Shaanxi, 710061
Huali Lin, Site 0186, 13679291619
Recruiting

Other trials in China

Romania11 sites, 8 recruiting

Local Institution - 0093
Bucharest, Bucharest, 041914
Site 0093
Not yet recruiting
Local Institution - 0100
Bucharest, Bucharest, 041914
Completed
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Valentin Matei, Site 0092, +40721243869
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
ADELA CIOBANU, Site 0098, 0040723671301
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Laura Cristina Dolis, Site 0094, 0040757243543
Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
SIMONA TRIFU, Site 0203, 0040731581100
Recruiting
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
Bucharest, 011241
Traian Purnichi, Site 0102, +40749156565
Recruiting
Local Institution - 0099
Bucharest, 0
Withdrawn
Local Institution - 0097
Iași, 700282
Withdrawn
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, 507190
Petru Ifteni, Site 0095, 0040724993329
Recruiting
Local Institution - 0101
Sibiu, 550082
Site 0101
Not yet recruiting

Other trials in Romania

Argentina6 sites, 6 recruiting

Local Institution - 0011
ABB, Buenos Aires F.D., C1199ABB
Site 0011
Not yet recruiting
Local Institution - 0010
Córdoba, 5000
Site 0010
Not yet recruiting
Local Institution - 0012
Córdoba, 5000
Site 0012
Not yet recruiting
Local Institution - 0008
Córdoba, X5003DCE
Site 0008
Not yet recruiting
Local Institution - 0009
Mendoza, 5502
Site 0009
Not yet recruiting
Clinica El Jardin
Santiago del Estero, 4200
Gaston Noriega, Site 0114, +5493854027710
Recruiting

Other trials in Argentina

Bulgaria5 sites, 4 recruiting

Local Institution - 0184
Kazanlak, Stara Zagora, 6100
Site 0184
Not yet recruiting
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
Novi Iskar, 1282
Tsveteslava Galabova, Site 0124, 359892444643
Recruiting
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, 5800
Maya Stoimenova - Popova, Site 0125, +359888227165
Recruiting
Local Institution - 0181
Sliven, 8800
Withdrawn
Local Institution - 0086
Targovishte, 7700
Site 0086
Not yet recruiting

Other trials in Bulgaria

France5 sites, 3 recruiting

Centre Hospitalier Universitaire de Clermont Ferrand
Clermont-Ferrand, 63000
pierre michel Llorca, Site 0085, 0473752124
Recruiting
Local Institution - 0087
Marseille, 13274
Withdrawn
Local Institution - 0129
Montpellier, 34295
Site 0129
Not yet recruiting
Local Institution - 0126
Nice, Alpes-Maritimes, 06000
Site 0126
Not yet recruiting
Local Institution - 0089
Paris, 75014
Withdrawn

Other trials in France

India5 sites, 4 recruiting

Local Institution - 0118
Kolkata, West Bengal, 700025
Site 0118
Not yet recruiting
Local Institution - 0116
Kolkata, 700014
Site 0116
Not yet recruiting
Local Institution - 0123
Madurai, Tamil Nadu, 625020
Site 0123
Not yet recruiting
Local Institution - 0207
Mangalore, 574143
Site 0207
Not yet recruiting
Local Institution - 0121
Mangaluru, Karnataka, 575003
Withdrawn

Other trials in India

Israel5 sites, 5 recruiting

Barzilai Medical Center
Ashkelon, Southern District, 7830604
daniela amital, Site 0053, 972506261544
Recruiting
Be'er Sheva Mental Health Center
Beersheba, Southern District, 8461144
Yuli Bersudsky, Site 0199
Recruiting
Shalvata Mental Health Center
Hod HaSharon, Central District, 4534708
Yuri Fonar, Site 0052, +972545838725
Recruiting
Local Institution - 0083
Jerusalem, 9112001
Site 0083
Not yet recruiting
Sheba Medical Center
Ramat Gan, Central District, 5265601
Linda Levi-Haramati, Site 0050, 0585950299
Recruiting

Other trials in Israel

Italy5 sites, 5 recruiting

Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
Umberto Volpe, Site 0004, 3498069293
Recruiting
IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
Genova, 16132
Gianluca Serafini, Site 0002, 00393475372316
Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Paolo Brambilla, Site 0003, 0255035982
Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
giulio perugi, Site 0005, +39335435387
Recruiting
Azienda Ospedaliero Universitaria Senese
Siena, Tuscany, 53100
Andrea Fagiolini, Site 0001, +390577585409
Recruiting

Other trials in Italy

Poland5 sites, 5 recruiting

Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
Bialystok, Podlaskie Voivodeship, 15-272
Napoleon Waszkiewicz, Site 0081, +48608888796
Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214
Wieslaw Cubala, Site 0113, +48503642588
Recruiting
Local Institution - 0103
Rybnik, Silesian Voivodeship, 44-200
Site 0103
Not yet recruiting
Clinica Inventiva
Tuszyn, 95-080
Jaroslaw Strzelec, Site 0082, 602305132
Recruiting
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, 02-957
Adam Wichniak, Site 0104, +48600-107-410
Recruiting

Other trials in Poland

Denmark3 sites, 3 recruiting

Aalborg Universitetshospital Psykiatrien
Aalborg, North Denmark, 9000
René Nielsen, Site 0054, 28722962
Recruiting
Glostrup Hospital
Glostrup Municipality, 2600
Bjørn Ebdrup, Site 0091, +4538640840
Recruiting
Local Institution - 0088
Hillerød, Capital Region, 3400
Site 0088
Not yet recruiting

Other trials in Denmark

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Conditions: Mania, Bipolar Disorder
Being tested: Xanomeline/Trospium Chloride, Placebo
Keywords: Bipolar-I Disorder, Mania, KarXT, adjunctive treatment, mood stabilizer
Medical subject headings: Mania, Bipolar Disorder

What participants receive

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

Xanomeline/Trospium ChlorideDrug
Also called KarXT, BMS-986510
Specified dose on specified days
PlaceboDrug
Specified dose on specified days

Study groups in NCT07140913
Study group	Role	What they receive
KarXT + Lithium, Valproate, or Lamotrigine	Experimental	Not described Receives: Drug: Xanomeline/Trospium Chloride
Placebo + Lithium, Valproate, or Lamotrigine	Placebo comparator	Not described Receives: Drug: 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) at Week 5
Measured: At Week 5

Secondary outcomes (11)

Change from baseline in Clinical Global Impressions Bipolar (CGI-BP) at Week 5
Measured: At Week 5
Occurrence of response at Week 5 assessed as the number of participants with a ≥ 50% decrease from baseline in Young Mania Rating Scale (YMRS) score
Measured: At Week 5
Occurrence of response at Week 5 assessed as the number of participants with a ≥ 1 change from baseline in CGI-BP
Measured: At Week 5
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Measured: Up to Week 7
Number of participants with Serious Adverse Events (SAEs)
Measured: Up to Week 7
Number of participants with TEAEs leading to treatment discontinuation
Measured: Up to Week 5
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to Week 7
Change from baseline in Barnes Akathisia Rating Scale (BARS) at Week 5
Measured: At Week 5
Change from baseline in Simpson Angus Scale (SAS) at Week 5
Measured: At Week 5
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) at Week 5
Measured: At Week 5
Change from baseline in International Prostate Symptom Score (IPSS) at Week 5
Measured: At Week 5

Timeline

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

8 Oct 202528 Jun 2027

First posted26 Aug 2025
Study start8 Oct 2025
Primary completion28 Jun 2027 (estimated)
Study completion28 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ManiaStudies 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: 424 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07140913
Sponsor's protocol ID: CN012-0046
Other IDs: 2025-521845-26, U1111-1321-1513, 2025
Status last verified: Nov 2026
First submitted: 21 Aug 2025
Last updated: 3 Nov 2026
Results posted: No
Data monitoring committee: Yes
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

Interested in taking part?

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286

Clinical.Trials@bms.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Bipolar Disorder Type I With Mania
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
Bipolar-I Disorder With Mania or Mania With Mixed Features
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Bipolar Disorder Type I With Mania or Mania With Mixed Features
RecruitingPhase 2
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
Bipolar I Disorder, Mania

All Mania trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Individuals With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
ClinicalTrials.gov ID: NCT07140913
Acronym / sponsor ID: CN012-0046
Conditions: Mania, Bipolar Disorder
Keywords: Bipolar-I Disorder, Mania, KarXT, adjunctive treatment, mood stabilizer
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 424 participants (estimated)
Lead sponsor: Bristol-Myers SquibbIndustry (pharma, biotech, devices)
Study start: 8 Oct 2025 (actual)
Primary completion: 28 Jun 2027 (estimated)
Study completion: 28 Jun 2027 (estimated)
First posted: 26 Aug 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to evaluate the efficacy and safety of adjunctive KarXT for the treatment of mania in participants with Bipolar-I Disorder.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
KarXT + Lithium, Valproate, or Lamotrigine	Experimental	Drug: Xanomeline/Trospium Chloride
Placebo + Lithium, Valproate, or Lamotrigine	Placebo comparator	Drug: Placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Individuals have a primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on the DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI) version 7.0.2.
Individual is experiencing an acute exacerbation or relapse of manic episode, with or without mixed features (≤ 3 weeks).
The individual requires hospitalization for the acute exacerbation or relapse of mania.
Body mass index ≥ 18 and ≤ 40 kg/m2.
Currently experiencing an acute episode of mania or mania with mixed features with a therapeutic dose of lithium, valproate, or lamotrigine. The dose of the mood stabilizer must have remained stable for at least two weeks prior to screening. Additionally, participants on valproate must have been receiving treatment with valproate for a minimum of seven months.

Key exclusion criteria (9 listed)

Any primary DSM-5-TR disorder other than BP-I within 12 months before screening (confirmed using MINI version 7.0.2 at screening) including BP-I depression (for previous 3 months only), BP-I with rapid cycling, first manic episode, BP-II, primary psychotic disorder, borderline personality disorder, and major depressive disorder, with the exception of mild anxiety disorders.
Individual has a DSM-5-TR diagnosis of moderate to severe substance use disorder (except tobacco use disorder) within the 12 months before screening (confirmed using MINI version 7.0.2 at screening), or current use as determined by urine toxicology screen or alcohol test.
Risk for suicidal behavior at screening as determined by the investigator's clinical assessment and the C-SSRS with an answer "Yes" to item 4 or 5 within 6 months before screening or between screening and baseline, or "Yes" to any of the 5 items (C-SSRS behavior) with an event occurring within the 12 months before screening, or between screening and baseline.
History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months.
History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Xanomeline/Trospium ChlorideAlso: KarXT, BMS-986510Specified dose on specified days	Drug	KarXT + Lithium, Valproate, or Lamotrigine
PlaceboSpecified dose on specified days	Drug	Placebo + Lithium, Valproate, or Lamotrigine

Primary outcome

Change from baseline in Young Mania Rating Scale (YMRS) at Week 5
Time frame: At Week 5

11 secondary outcomes

Change from baseline in Clinical Global Impressions Bipolar (CGI-BP) at Week 5
Time frame: At Week 5
Occurrence of response at Week 5 assessed as the number of participants with a ≥ 50% decrease from baseline in Young Mania Rating Scale (YMRS) score
Time frame: At Week 5
Occurrence of response at Week 5 assessed as the number of participants with a ≥ 1 change from baseline in CGI-BP
Time frame: At Week 5
Number of participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to Week 7
Number of participants with Serious Adverse Events (SAEs)
Time frame: Up to Week 7
Number of participants with TEAEs leading to treatment discontinuation
Time frame: Up to Week 5
Change from baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to Week 7
Change from baseline in Barnes Akathisia Rating Scale (BARS) at Week 5
Time frame: At Week 5
Change from baseline in Simpson Angus Scale (SAS) at Week 5
Time frame: At Week 5
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) at Week 5
Time frame: At Week 5
Change from baseline in International Prostate Symptom Score (IPSS) at Week 5
Time frame: At Week 5

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
BMS Clinical Trial InformationLink provided by the sponsor.
BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
Individual participant dataSharing planned: 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

Related trials for Mania

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RecruitingPhase 3
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
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RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
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A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
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RecruitingPhase 2
An Assessment of Efficacy, Safety, and Pharmacokinetics of NBI-1117568 in Adults With Bipolar I Disorder With Current Mania
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take 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

Bristol-Myers Squibb study director

Bristol-Myers Squibb

109 sites in 13 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Xanomeline/Trospium Chloride in people with Mania and Bipolar Disorder, run by Bristol-Myers Squibb at 109 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 109 sites in United States, Japan, Ukraine, China, Romania and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact BMS Clinical Trials Contact Center www.BMSClinicalTrials.com (855-907-3286, Clinical.Trials@bms.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Young Mania Rating Scale (YMRS) at Week 5 (time frame: At Week 5). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07140913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.