Bipolar Disorder Type I With ManiaPhase 3NCT06929273
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
A Phase 3 study testing KarXT, Lithium and Valproate in people with Bipolar Disorder Type I With Mania, run by Bristol-Myers Squibb at 182 sites in 20 countries.
Trial summary
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I) The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or… 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
- What is being tested?
- KarXT, Lithium and Valproate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 182 sitesin 20 countries
- Study dates
- 18 Jul 2025to 13 Jun 2028
- 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 who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):
- Participants must have completed treatment period of parent study.
- De novo participants who did not participate in double-blind placebo-controlled studies:
- Participants must have primary diagnosis of Bipolar-I disorder established by a comprehensive psychiatric evaluation based on DSM-5-TR criteria and confirmed by the Mini International Neuropsychiatric Interview (MINI, v7.0.2), with symptoms of mania or mixed mania.
- Participants must have Young Mania Rating Scale (YMRS) score of ≥ 14 at Screening and at baseline.
- Participants must have CGI-BP score of ≥ 3 at Screening and at baseline.
- Participants does not require hospitalization for acute mania.
Who cannot join
- All participants:
- 1. All participants with a risk for suicidal behavior at baseline as determined by Investigator's clinical assessment or history of suicidal behavior as assessed on C-SSRS.
- Participants who participated in double-blind placebo-controlled study (CN0120036, CN0120037, or CN0120046):
- 1. Discontinuation from any KarXT parent studies.
- De novo participants who did not participate in double-blind placebo-controlled studies:
- Participants must not have primary diagnosis of BP-I with rapid cycling (ie, ≥ 4 distinct mood episodes in one year).
Show all 11Show fewer
- Participants must not have any primary DSM-5-TR disorder other than BP-I with mania or mania with mixed features within 12 months before Screening (confirmed using MINI version 7.0.2 at Screening), including BP-I with depression, (previous 3 months only), Bipolar-II disorder, major depressive disorder, borderline personality disorder, and primary psychotic 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.
- Participants must not have history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
- Participants must not have 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
182 sites in 20 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
182 sites in 20 countries
United States61 sites, 55 recruiting
- Recruiting
Advanced Research Center Inc.
Anaheim, California, 92805
Steven Macina, Site 0027, 714-999-6688
- Recruiting
Synexus Clinical Research US, Inc.
Atlanta, Georgia, 30328
Bethany Davis, Site 0052, 404-255-6005
- Recruiting
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
Elyssa Barron, Site 0054, 404-881-5800
- Recruiting
Community Clinical Research
Austin, Texas, 78754
David Brown, Site 0134, 512-323-2622
- Recruiting
Clinical Innovations, Inc. dba CITrials
Bellflower, California, 90706
Robert Bota, Site 0050, 229-815-0219
- Recruiting
Pillar Clinical Research - Richardson
Bentonville, Arkansas, 72712
Fayz Hudefi, Site 0022, 479-367-2688
- Not yet recruiting
Local Institution - 0199
Carrollton, Texas, 75010
Site 0199
- Not yet recruiting
Local Institution - 0044
Cerritos, California, 90703
Site 0044
- Not yet recruiting
Local Institution - 0201
Cerritos, California, 90703
Site 0201
- Withdrawn
Local Institution - 0124
Charlotte, North Carolina, 28211
- Not yet recruiting
Local Institution - 0031
Chicago, Illinois, 60640
Site 0031
- Recruiting
Pillar Clinical Research -Chicago
Chicago, Illinois, 60641
Roueen Rafeyan, Site 0020, 312-865-6336
- Recruiting
Inland Psychiatric Medical Group - Chino
Chino, California, 91710
Nandita Puchakayala, Site 0135, 909-488-9116
- Recruiting
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
Caleb Adler, Site 0055, 513-404-0279
- Not yet recruiting
Local Institution - 0203
Colorado Springs, Colorado, 80910
Site 0203
- Recruiting
Proscience Research Group
Culver City, California, 90230
Marina Bussel, Site 0037, 424-227-8127
- Recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
Kimball Johnson, Site 0023, 404-537-1281
- Recruiting
Adams Clinical Dallas
DeSoto, Texas, 75115
Rajinder Shiwach, Site 0048, 972-283-6286
- Recruiting
Precise Research Centers
Flowood, Mississippi, 39232
Joseph Kwentus, Site 0029, 601-420-5810
- Recruiting
CBH Health
Gaithersburg, Maryland, 20877
Elia Acevedo Diaz, Site 0049, 301-251-4702
- Recruiting
Collaborative Neuroscience Research, LLC
Garden Grove, California, 92845-2506
David Walling, Site 0085, 714-799-7799
- Not yet recruiting
Local Institution - 0120
Glendale, Arizona, 85304
Site 0120
- Recruiting
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, 33009
Beth Safirstein, Site 0133
- Not yet recruiting
Local Institution - 0026
Hialeah Gardens, Florida, 33016
Site 0026
- Recruiting
Behavioral Clinical Research
Hollywood, Florida, 33021
Olga Lapeyra, Site 0059, 954-375-7794
- Recruiting
Research Centers of America ( Hollywood )
Hollywood, Florida, 33024
Edwin Gomez, Site 0053, 954-604-3900
- Withdrawn
Local Institution - 0046
Houston, Texas, 77021
- Recruiting
Elevate Clinical Research-Houston
Houston, Texas, 77058
Matthews Brams, Site 0138, 409-331-6040
- Withdrawn
Local Institution - 0036
Irving, Texas, 75062
- Recruiting
Omega Clinical Trials - La Habra
La Habra, California, 90631
Wakelin McNeel, Site 0137, 562-690-2200
- Not yet recruiting
Local Institution - 0197
Lincoln, Nebraska, 68526
Site 0197
- Recruiting
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, 72204
Leslie Smith, Site 0021, 501-350-3285
- Recruiting
Woodland International Research Group
Little Rock, Arkansas, 72211
George Konis, Site 0038, 501-221-8681
- Recruiting
Prime Clinical Research - Mansfield
Mansfield, Texas, 76063
Jamie Alexander, Site 0139, 817-907-7330
- Recruiting
Hassman Research Institute Marlton Site
Marlton, New Jersey, 08053
Elan Cohen, Site 0130, 267-981-8911
- Withdrawn
Local Institution - 0058
Marlton, New Jersey, 08053
- Recruiting
LCC Medical Research Institute
Miami, Florida, 33126
Yesenia Kuan, Site 0030, 305-400-0814
- Recruiting
Advanced Research Institute of Miami
Miami, Florida, 33135
Moraima Trujillo, Site 0028, 305-246-0001
- Recruiting
Innovative Clinical Research, Inc.
Miami Lakes, Florida, 33016
Rishi Kakar, Site 0047, 786-512-4106
- Recruiting
South Florida Research Phase I-IV
Miami Springs, Florida, 33166
Silvia Silva Duluc, Site 0025, 305-669-6166
- Recruiting
Catalina Research Institute, LLC
Montclair, California, 91763
Stephen Volk, Site 0056, 909-590-8409
- Recruiting
Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, 06510
Deepak D'Souza, Site 0131, 20393257112594
- Recruiting
Neuro-Behavioral Clinical Research
North Canton, Ohio, 44720
Shishuka Malhotra, Site 0040, 330-493-1118
- Not yet recruiting
Local Institution - 0121
North Las Vegas, Nevada, 89030
Site 0121
- Withdrawn
Local Institution - 0122
North Las Vegas, Nevada, 89030
- Not yet recruiting
Local Institution - 0200
Northridge, California, 91325
Site 0200
- Recruiting
NRC Research Institute
Orange, California, 92868
Tony Ortiz, Site 0039, 714-289-1100
- Recruiting
Pillar Clinical Research - Richardson
Richardson, Texas, 75080
Scott Bartley, Site 0034, 214-396-4844
- Recruiting
Clinical Innovations, Inc. dba CITrials
Riverside, California, 92506
Evagelos Coskinas, Site 0043, 951300492
- Recruiting
Woodland Research Northwest
Rogers, Arkansas, 72758
Robert Billingsley, Site 0057, 479-927-3000
- Withdrawn
Local Institution - 0136
Santa Ana, California, 92705
- Recruiting
CenExel iResearch, LLC
Savannah, Georgia, 31405
Michael Mobley, Site 0024, 912-744-0800
- Not yet recruiting
Local Institution - 0204
Scottsdale, Arizona, 85260
Site 0204
- Recruiting
Arch Clinical Trials
St Louis, Missouri, 63141
Junaid Syed, Site 0042, 314-771-6387
- Not yet recruiting
Local Institution - 0045
St. Petersburg, Florida, 33713
Site 0045
- Recruiting
Richmond Behavioral Associates
Staten Island, New York, 10314
Peter Weiden, Site 0033, 917-701-7484
- Recruiting
Collaborative Neuroscience Research, LLC
Torrance, California, 90504
Lara Shirikjian, Site 0123, 310-523-4200
- Not yet recruiting
Local Institution - 0205
Tucson, Arizona, 85704
Site 0205
- Not yet recruiting
Local Institution - 0202
West Chester, Ohio, 45069
Site 0202
- Recruiting
Health Synergy Clinical Research
West Palm Beach, Florida, 33407
Mohammad Nisar, Site 0032, 786-831-7303
- Not yet recruiting
Local Institution - 0198
Wichita Falls, Texas, 76309
Site 0198
Japan24 sites, 20 recruiting
- Recruiting
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Tadafumi Kato, Site 0163, +81-(0)3-3813-3111
- Recruiting
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, 1138603
Amane Tateno, Site 0164, +81-3-3822-2131
- Recruiting
Kuramitsu Hospital
Fukuoka, 819-0037
Noriko Tamaru, Site 0006, +81-92-811-1821
- Recruiting
National Kohnodai Medical Center.
Ichikawa, Chiba, 272-8516
Toshihiko Ito, Site 0001, +81-47-372-3501
- Withdrawn
Local Institution - 0166
Iizuka, Fukuoka, 820-8505
- Withdrawn
Local Institution - 0016
Iruma, Saitama, 350-0495
- Recruiting
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, 847-0031
Taro Shindo, Site 0011, 0955770711
- Withdrawn
Local Institution - 0063
Kitakyushu, Fukuoka, 803-0831
- Recruiting
Kochi Health Sciences Center
Kochi, 781-8555
Ken Sawada, Site 0161, +81-88-837-3000
- Recruiting
National Center of Neurology and Psychiatry
Kodaira, Tokyo, 187-8551
Takamasa Noda, Site 0072, +81-42-341-2711
- Recruiting
Hotei Hospital
Kōnan, Aichi-ken, 4838248
Takakura Masashi, Site 0008, +81587557251
- Recruiting
Saitama Konan Hospital
Kumagaya, Saitama, 360-0114
Narifumi Yokoyama, Site 0012, 048-536-1366
- Recruiting
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, 880-8510
Jiro Kawano, Site 0004, 81985244181
- Recruiting
Kansai Medical University Medical Center
Moriguchi, Osaka, 570-8507
Masaki Kato, Site 0013, +81-6-6992-1001
- Recruiting
Obihiro Kosei Hospital
Obihiro, Hokkaido, 080-0024
Kengo Furuse, Site 0015, 81155650102
- Recruiting
Osaka Metropolitan University Hospital
Osaka, 545-8586
Yasuhiko Deguchi, Site 0010, +81-6-6645-3821
- Withdrawn
Local Institution - 0007
Sakai-shi, Osaka, 590-0018
- Recruiting
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, 002-8029
Kimihiro Nakajima, Site 0005, +81-11-771-5660
- Recruiting
Narimasu Kosei Hospital
tabashi City, Tokyo, 175-0091
Yuya Tenjin, Site 0009, 0339391191
- Recruiting
Showa Medical University Karasuyama Hospital
Tokyo, 157-8577
Kenji Sanada, Site 0073, +81-3-3300-5231
- Recruiting
Okehazama Hospital
Toyoake, Aichi-ken, 470-1168
kiyoshi Fujita, Site 0003, 0562971361
- Recruiting
Wakayama Medical University Hospital
Wakayama, 641-8510
Sohei Kimoto, Site 0002, 073-441-0659
- Recruiting
Yamagata Sakuracho Hospital
Yamagata, 990-0045
Nobuhiro Yokokawa, Site 0014, +81236312315
- Recruiting
Hino Hospital - Yokohama
Yokohama, Kanagawa, 234-0051
Atsuomi Baba, Site 0165, +81-45-843-8511
Ukraine12 sites, 12 recruiting
- Not yet recruiting
Local Institution - 0149
Dnipro, 49115
Site 0149
- Not yet recruiting
Local Institution - 0143
Hlevakha, Kyivska Oblast, 08631
Site 0143
- Not yet recruiting
Local Institution - 0151
Kropyvnytskyi, 25491
Site 0151
- Not yet recruiting
Local Institution - 0150
Kyiv, 04080
Site 0150
- Not yet recruiting
Local Institution - 0147
Lviv, Lviv Oblast, 79021
Site 0147
- Not yet recruiting
Local Institution - 0145
Odesa, Odesa Oblast, 67513
Site 0145
- Not yet recruiting
Local Institution - 0144
Odesa, 65006
Site 0144
- Not yet recruiting
Local Institution - 0141
Poltava, 36013
Site 0141
- Not yet recruiting
Local Institution - 0146
Skarzhyntsi, Khmelnytskyi Oblast, 32120
Site 0146
- Not yet recruiting
Local Institution - 0152
Smila, Cherkasy Oblast, 20708
Site 0152
- Not yet recruiting
Local Institution - 0189
Ternopil, 46000
Site 0189
- Not yet recruiting
Local Institution - 0148
Vinnytsia, Vinnytsia Oblast, 21037
Site 0148
Romania11 sites, 11 recruiting
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Valentin Matei, Site 0101, +40721243869
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Mihnea Manea, Site 0102, 0040745974029
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
SIMONA TRIFU, Site 0099, 0040731581100
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Corina Nicolae, Site 0098, +40727818190
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
Laura Cristina Dolis, Site 0095, 0040757243543
- Recruiting
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, 041914
ADELA CIOBANU, Site 0096, 0040723671301
- Recruiting
Institutul Național de Gerontologie și Geriatrie "Ana Aslan"
Bucharest, 011241
Traian Purnichi, Site 0167, +40749156565
- Recruiting
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
Bucharest, 060222
Traian Barbu, Site 0104, +40723652564
- Recruiting
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
Bucharest, 0
Octavian Vasiliu, Site 0094, 0040723725815
- Not yet recruiting
Local Institution - 0097
Iași, 700282
Site 0097
- Recruiting
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, 507190
Petru Ifteni, Site 0100, 0040724993329
China10 sites, 10 recruiting
- Not yet recruiting
Local Institution - 0181
Baoding, Hebei, 071000
Site 0181
- Not yet recruiting
Local Institution - 0177
Beijing, Beijing Municipality, 100088
Site 0177
- Not yet recruiting
Local Institution - 0174
Beijing, Beijing Municipality, 100096
Site 0174
- Not yet recruiting
Local Institution - 0184
Changsha, Hunan, 410011
Site 0184
- Not yet recruiting
Local Institution - 0179
Chengdu, Sichuan, 610036
Site 0179
- Not yet recruiting
Local Institution - 0175
Guangzhou, Guangdong, 510370
Site 0175
- Not yet recruiting
Local Institution - 0180
Nanjing, Jiangsu, 210029
Site 0180
- Not yet recruiting
Local Institution - 0182
Ningbo, Zhejiang, 315201
Site 0182
- Not yet recruiting
Local Institution - 0183
Tianjin, Tianjin Municipality, 300022
Site 0183
- Recruiting
Xi An Mental Health Center
Xi'an, Shaanxi, 710061
Huali Lin, Site 0176, 13679291619
India10 sites, 10 recruiting
- Not yet recruiting
Local Institution - 0132
Belagavi, Karnataka, 590010
Site 0132
- Recruiting
Asha Hospital - Hyderabad
Hyderabad, Telangana, 500034
G Rao, Site 0078, 9985900005
- Not yet recruiting
Local Institution - 0080
Hyderabad, Telangana, 500082
Site 0080
- Recruiting
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014
Asish Mukhopadhyay, Site 0076, 8250737511
- Not yet recruiting
Local Institution - 0160
Kolkata, West Bengal, 700025
Site 0160
- Recruiting
Chethana Center for Neuropsychiatry
Kozhikode, Kerala, 673009
SURESHKUMAR N, Site 0079, 9447218825
- Recruiting
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001
Navkiran Mahajan, Site 0077, 9872655008
- Not yet recruiting
Local Institution - 0158
Madurai, Tamil Nadu, 625020
Site 0158
- Not yet recruiting
Local Institution - 0190
Mangalore, Karnataka, 574143
Site 0190
- Not yet recruiting
Local Institution - 0111
Vadodara, Gujarat, 390021
Site 0111
Israel8 sites, 8 recruiting
- Recruiting
Barzilai Medical Center
Ashkelon, 78306
daniela amital, Site 0173, 972506261544
- Recruiting
Be'er Sheva Mental Health Center
Beersheba, Southern District, 8461144
Yuly Bersudsky, Site 0106, 972-8-6401463
- Recruiting
Shalvata Mental Health Center
Hod HaSharon, Central District, 4534708
Yuri Fonar, Site 0068, +972545838725
- Not yet recruiting
Local Institution - 0168
Jerusalem, 91120
Site 0168
- Recruiting
Kfar Shaul Mental Health Center
Jerusalem, 9546105
Alexander Teitelbaum, Site 0074, +972-506262005
- Recruiting
Ness Ziona Mental Health Center
Ness Ziona, Central District, 7410001
Marina Kupchik, Site 0075, +972506261093
- Not yet recruiting
Local Institution - 0084
Petah Tikva, Central District, 4910002
Site 0084
- Recruiting
Sheba Medical Center
Ramat Gan, Central District, 5265601
Linda Levi-Haramati, Site 0067, 0585950299
Bulgaria7 sites, 7 recruiting
- Recruiting
Center for Mental Health Prof. Dr. Ivan Temkov
Burgas, 8001
Veselin Palazov, Site 0082, 359888451225
- Not yet recruiting
Local Institution - 0191
Haskovo, 6300
Site 0191
- Not yet recruiting
Local Institution - 0188
Kazanlak, Stara Zagora, 6100
Site 0188
- Recruiting
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
Novi Iskar, 1282
Tsveteslava Galabova, Site 0107, 359892444643
- Recruiting
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, 5800
Maya Stoimenova - Popova, Site 0081, +359888227165
- Recruiting
MHAT "Dr. Ival Seliminski"
Sliven, 8800
Rozalina Petrova, Site 0113, 00359887801545
- Recruiting
Mental Health Center - Vratsa
Vratsa, 3000
Nadya Ivanova, Site 0114, +359887422440
Poland6 sites, 6 recruiting
- Recruiting
Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
Bialystok, Podlaskie Voivodeship, 15-272
Napoleon Waszkiewicz, Site 0090, +48608888796
- Recruiting
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, 80-214
Wieslaw Cubala, Site 0093, +48503642588
- Recruiting
Centrum Medyczne HCP
Poznan, Greater Poland Voivodeship, 61-485
Sylwia Szymkowiak, Site 0088, +48604116632
- Recruiting
M2M Med
Rybnik, Silesian Voivodeship, 44-200
Wojciech Eysymontt, Site 0089, +48609673001
- Recruiting
Clinica Inventiva
Tuszyn, 95-080
Jaroslaw Strzelec, Site 0091, 602305132
- Recruiting
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, 02-957
Adam Wichniak, Site 0092, +48600-107-410
Croatia5 sites, 4 recruiting
- Withdrawn
Local Institution - 0018
Zagreb, City of Zagreb, 10090
- Recruiting
Klinika za psihijatriju "Vrapče"
Zagreb, 10090
Miroslav Herceg, Site 0017, 3853780732
- Recruiting
Klinika za psihijatriju "Vrapče"
Zagreb, 10090
Ninoslav Mimica, Site 0103, +38513780678
- Recruiting
Klinika za psihijatriju "Vrapče"
Zagreb, 10090
Marko Curkovic, Site 0129, 385951648446
- Recruiting
Psihijatrijska bolnica "Sveti Ivan"
Zagreb, 10090
Igor Filipcic, Site 0019, 38513430020
Italy5 sites, 5 recruiting
- Recruiting
Azienda Ospedaliero Universitaria delle Marche
Ancona, 60126
Umberto Volpe, Site 0070, 3498069293
- Recruiting
IRCCS Azienda Ospedaliera Metropolitana - Ospedale Policlinico San Martino
Genova, 16132
Gianluca Serafini, Site 0069, 00393475372316
- Recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
Paolo Brambilla, Site 0066, 0255035982
- Recruiting
Azienda Ospedaliero Universitaria Pisana
Pisa, Tuscany, 56126
giulio perugi, Site 0083, +39335435387
- Recruiting
Azienda Ospedaliero Universitaria Senese
Siena, Tuscany, 53100
Andrea Fagiolini, Site 0065, +390577585409
Argentina3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0128
ABB, Buenos Aires F.D., C1199ABB
Site 0128
- Recruiting
Sanatorio Morra S.A.
Córdoba, 5000
Carlos Morra, Site 0127, 5493516858696
- Not yet recruiting
Local Institution - 0126
Mendoza, 5502
Site 0126
France3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0171
Clermont-Ferrand, 63000
Site 0171
- Not yet recruiting
Local Institution - 0172
Montpellier, 34295
Site 0172
- Not yet recruiting
Local Institution - 0170
Nice, Alpes-Maritimes, 06000
Site 0170
Hungary3 sites, 3 recruiting
- Recruiting
Semmelweis Egyetem
Budapest, 1083
János Réthelyi, Site 0108, +3612100336
- Recruiting
Nyírő Gyula Országos Pszichiátriai és Addiktológiai Intézet
Budapest, 1135
Csaba Almasi, Site 0110, +36 30 604 9696
- Recruiting
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, 9024
Gabor Feller, Site 0109
Slovakia3 sites, 3 recruiting
- Not yet recruiting
Local Institution - 0119
Košice, Košice Region, 040 01
Site 0119
- Recruiting
Univerzitna Nemocnica L. Pasteura Kosice
Košice, Košice Region, 040 01
Slavka Dubinska, Site 0118, +421903625643
- Not yet recruiting
Local Institution - 0117
Vranov nad Topľou, Presov, 093 01
Site 0117
Spain3 sites, 2 recruiting
- Completed
Local Institution - 0115
Barcelona, Barcelona [Barcelona], 08035
- Recruiting
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], 08036
Eduard Vieta, Site 0071, 932275400
- Recruiting
Osi Bilbao-Basurto
Bilbao, Basque Country, 48013
Ana Catalan, Site 0064, 669736802
Sweden3 sites, 1 recruiting
- Withdrawn
Local Institution - 0116
Gothenburg, Västra Götalands Län [se-14], 413 45
- Recruiting
Nacka Local Hospital
Nacka, Stockholms Län [se-01], 131 45
Andreas Carlborg, Site 0125, +46(0)8-12341043
- Withdrawn
Local Institution - 0112
Uppsala, Uppsala Län [se-03], 751 85
Australia2 sites, 2 recruiting
- Recruiting
Ramsay Clinic New Farm
Brisbane, Queensland, 4005
James Scott, Site 0087, 0408707842
- Recruiting
Ramsay Clinic Northside
St Leonards, New South Wales, 2065
Philip Mitchell, Site 0105, 0294331546
Denmark2 sites, 2 recruiting
- Recruiting
Aalborg Universitetshospital Psykiatrien
Gistrup, 9260
René Nielsen, Site 0153, 28722962
- Recruiting
Glostrup Hospital
Glostrup Municipality, 2600
Bjørn Ebdrup, Site 0154, +4538640840
New Zealand1 site, 1 recruiting
- Recruiting
North Shore Hospital
Auckland, 0622
Sylvester Miles, Site 0086, +6421963555
About this study
Official title: A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for the Treatment of Mania or Mania With Mixed Features in Bipolar-I Disorder (BALSAM-3)
This is a phase 3, open-label extension study to assess the long-term safety of KarXT for the treatment of mania or mania with mixed features in Bipolar-I disorder (BP-I)
The primary objective of the study is to evaluate the long-term safety and tolerability of KarXT in the treatment of participants with mania or mania with mixed features associated with BP-I.
- Conditions
- Bipolar Disorder Type I With Mania
- Being tested
- KarXT, Lithium, Valproate, Lamotrigine
- 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
LithiumDrug
Therapeutic dose
ValproateDrug
Therapeutic dose
LamotrigineDrug
Therapeutic dose
| Study group | Role | What they receive |
|---|---|---|
| KarXT or Adjuvant KarXT | Experimental | Not described Receives: Drug: KarXT; Drug: Lithium; Drug: Valproate; Drug: Lamotrigine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment emergent adverse events (TEAEs)
Measured: Up to week 54
Secondary outcomes (8)
Number of participants with AEs of special interest (AESIs)
Measured: Up to week 54
Number of participants with serious AEs (SAEs)
Measured: Up to week 54
Number of participants with TEAEs leading to treatment discontinuation
Measured: Up to week 52
Number of participants with change in suicidal ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Up to week 54
Change from baseline in Barnes Akathisia Rating Scale (BARS) score
Measured: Up to week 54
Change from baseline in Simpson Angus Scale (SAS) score
Measured: Up to week 54
Change from baseline in Abnormal Involuntary Movement Scale (AIMS) score
Measured: Up to week 54
Change from baseline in International Prostate Symptom Score (IPSS)
Only for males ≥ 45 years of age
Measured: Up to week 54
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2025
- Study start18 Jul 2025
- Primary completion13 Jun 2028 (estimated)
- Study completion13 Jun 2028 (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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 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
- NCT06929273
- Sponsor's protocol ID
- CN012-0038
- Other IDs
- U1111-1316-9287, 2024-520259-26
- Status last verified
- Sep 2026
- First submitted
- 14 Apr 2025
- Last updated
- 14 Sep 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