Actively Recruiting
A Phase 3, Open-label Extension Study to Assess the Long-term Safety of KarXT for Mania or Mania With Mixed Features in Bipolar-I Disorder
Led by Bristol-Myers Squibb · Updated on 2026-06-02
450
Participants Needed
173
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and tolerability of KarXT in adults with Bipolar-I disorder experiencing mania or mania with mixed features. This phase 3, open-label extension study focuses on participants who either completed specific previous clinical trials or are newly diagnosed with Bipolar-I disorder according to DSM-5-TR criteria and confirmed by psychiatric interviews. The study aims to better understand the safety profile of KarXT for managing manic episodes in this population. Participants will receive KarXT at specified doses over the course of the study, with some possibly also receiving adjuvant treatments such as lithium, valproate, or lamotrigine at therapeutic doses. The study includes an initial treatment period followed by ongoing monitoring to assess safety and tolerability. It is open-label, meaning both participants and researchers know the treatment being given. During the study, participants will undergo regular assessments including monitoring for adverse events, changes in suicidal thoughts using the Columbia-Suicide Severity Rating Scale (C-SSRS), and evaluations of movement disorders using scales such as the Barnes Akathisia Rating Scale (BARS), Simpson Angus Scale (SAS), and Abnormal Involuntary Movement Scale (AIMS). The study will last up to 54 weeks and aims to collect comprehensive safety data while participants continue treatment under medical supervision.
CONDITIONS
Brief Title
A Study to Assess the Long-term Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-3)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants who completed treatment in a specific double-blind placebo-controlled parent study
- Adults aged 18 to 65 years
- Primary diagnosis of Bipolar-I disorder with mania or mixed mania confirmed by psychiatric evaluation and MINI interview
- Young Mania Rating Scale (YMRS) score of 14 or higher at screening and baseline
- Clinical Global Impression-Bipolar (CGI-BP) score of 3 or higher at screening and baseline
- Participants do not require hospitalization for acute mania
You will not qualify if you...
- Participants who discontinued from any KarXT parent studies
- Participants with risk or history of suicidal behavior at baseline
- Participants with rapid cycling Bipolar-I disorder (4 or more mood episodes in one year)
- Participants with other primary DSM-5-TR disorders within 12 months before screening, except mild anxiety disorders
- Moderate to severe substance use disorder within 12 months before screening, or current use detected by tests
- History of irritable bowel syndrome or serious constipation requiring treatment in the last 6 months
- History or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma
- Other protocol-defined inclusion and exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 54 weeks
Participants receive KarXT or adjuvant KarXT along with therapeutic doses of Lithium, Valproate, or Lamotrigine for the treatment of manic episodes in Bipolar-I disorder.
Trial Site Locations
Total: 173 locations
1
Local Institution - 0120
Glendale, Arizona, United States, 85304
Not Yet Recruiting
2
Pillar Clinical Research - Richardson
Bentonville, Arkansas, United States, 72712
Actively Recruiting
3
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States, 72204
Actively Recruiting
4
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Actively Recruiting
5
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
Actively Recruiting
6
Advanced Research Center Inc.
Anaheim, California, United States, 92805
Actively Recruiting
7
Clinical Innovations, Inc. dba CITrials
Bellflower, California, United States, 90706
Actively Recruiting
8
Local Institution - 0044
Cerritos, California, United States, 90703
Not Yet Recruiting
9
Inland Psychiatric Medical Group - Chino
Chino, California, United States, 91710
Actively Recruiting
10
Proscience Research Group
Culver City, California, United States, 90230
Actively Recruiting
11
Collaborative Neuroscience Research, LLC
Garden Grove, California, United States, 92845-2506
Actively Recruiting
12
Omega Clinical Trials - La Habra
La Habra, California, United States, 90631
Actively Recruiting
13
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Actively Recruiting
14
NRC Research Institute
Orange, California, United States, 92868
Actively Recruiting
15
Clinical Innovations, Inc. dba CITrials
Riverside, California, United States, 92506
Actively Recruiting
16
Local Institution - 0136
Santa Ana, California, United States, 92705
Not Yet Recruiting
17
Collaborative Neuroscience Research, LLC
Torrance, California, United States, 90504
Actively Recruiting
18
Yale New Haven Hospital-Smilow Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
19
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States, 33009
Actively Recruiting
20
Local Institution - 0026
Hialeah Gardens, Florida, United States, 33016
Not Yet Recruiting
21
Behavioral Clinical Research
Hollywood, Florida, United States, 33021
Actively Recruiting
22
Research Centers of America ( Hollywood )
Hollywood, Florida, United States, 33024
Actively Recruiting
23
LCC Medical Research Institute
Miami, Florida, United States, 33126
Actively Recruiting
24
Advanced Research Institute of Miami
Miami, Florida, United States, 33135
Actively Recruiting
25
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States, 33016
Actively Recruiting
26
South Florida Research Phase I-IV
Miami Springs, Florida, United States, 33166
Actively Recruiting
27
Local Institution - 0045
St. Petersburg, Florida, United States, 33713
Not Yet Recruiting
28
Health Synergy Clinical Research
West Palm Beach, Florida, United States, 33407
Actively Recruiting
29
Synexus Clinical Research US, Inc.
Atlanta, Georgia, United States, 30328
Actively Recruiting
30
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
31
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
32
CenExel iResearch, LLC
Savannah, Georgia, United States, 31405
Actively Recruiting
33
Local Institution - 0031
Chicago, Illinois, United States, 60640
Not Yet Recruiting
34
Pillar Clinical Research -Chicago
Chicago, Illinois, United States, 60641
Actively Recruiting
35
CBH Health
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
36
Precise Research Centers
Flowood, Mississippi, United States, 39232
Actively Recruiting
37
Arch Clinical Trials
St Louis, Missouri, United States, 63141
Actively Recruiting
38
Local Institution - 0121
North Las Vegas, Nevada, United States, 89030
Not Yet Recruiting
39
Local Institution - 0122
North Las Vegas, Nevada, United States, 89030
Withdrawn
40
Hassman Research Institute Marlton Site
Marlton, New Jersey, United States, 08053
Actively Recruiting
41
Local Institution - 0058
Marlton, New Jersey, United States, 08053
Withdrawn
42
Richmond Behavioral Associates
Staten Island, New York, United States, 10314
Actively Recruiting
43
Local Institution - 0124
Charlotte, North Carolina, United States, 28211
Withdrawn
44
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
45
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States, 44720
Actively Recruiting
46
Community Clinical Research
Austin, Texas, United States, 78754
Actively Recruiting
47
InSite Clinical Research
DeSoto, Texas, United States, 75115
Actively Recruiting
48
Local Institution - 0046
Houston, Texas, United States, 77021
Withdrawn
49
Elevate Clinical Research-Houston
Houston, Texas, United States, 77058
Actively Recruiting
50
Local Institution - 0036
Irving, Texas, United States, 75062
Withdrawn
51
Prime Clinical Research - Mansfield
Mansfield, Texas, United States, 76063
Actively Recruiting
52
Pillar Clinical Research - Richardson
Richardson, Texas, United States, 75080
Actively Recruiting
53
Local Institution - 0128
ABB, Buenos Aires F.D., Argentina, C1199ABB
Not Yet Recruiting
54
Local Institution - 0127
Córdoba, Argentina, 5000
Not Yet Recruiting
55
Local Institution - 0126
Mendoza, Argentina, 5502
Not Yet Recruiting
56
Ramsay Clinic Northside
St Leonards, New South Wales, Australia, 2065
Actively Recruiting
57
Ramsay Clinic New Farm
Brisbane, Queensland, Australia, 4005
Actively Recruiting
58
Center for Mental Health Prof. Dr. Ivan Temkov
Burgas, Bulgaria, 8001
Actively Recruiting
59
State Psychiatric Hospital Sv. Ivan Rilski Novi Iskar
Novi Iskar, Bulgaria, 1282
Actively Recruiting
60
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, Bulgaria, 5800
Actively Recruiting
61
MHAT "Dr. Ival Seliminski"
Sliven, Bulgaria, 8800
Actively Recruiting
62
Mental Health Center - Vratsa
Vratsa, Bulgaria, 3000
Actively Recruiting
63
Local Institution - 0177
Beijing, Beijing Municipality, China, 100088
Not Yet Recruiting
64
Local Institution - 0174
Beijing, Beijing Municipality, China, 100096
Not Yet Recruiting
65
Local Institution - 0175
Guangzhou, Guangdong, China, 510370
Not Yet Recruiting
66
Local Institution - 0181
Baoding, Hebei, China, 71000
Not Yet Recruiting
67
Local Institution - 0185
Shijiazhuang, Hebei, China, 050031
Not Yet Recruiting
68
Local Institution - 0184
Changsha, Hunan, China, 410011
Not Yet Recruiting
69
Local Institution - 0180
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
70
Local Institution - 0176
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
71
Local Institution - 0179
Chengdu, Sichuan, China, 610036
Not Yet Recruiting
72
Local Institution - 0183
Tianjin, Tianjin Municipality, China, 300022
Not Yet Recruiting
73
Local Institution - 0182
Ningbo, Zhejiang, China, 315201
Not Yet Recruiting
74
Local Institution - 0018
Zagreb, City of Zagreb, Croatia, 10090
Withdrawn
75
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia, 10090
Actively Recruiting
76
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia, 10090
Actively Recruiting
77
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia, 10090
Actively Recruiting
78
Psihijatrijska bolnica "Sveti Ivan"
Zagreb, Croatia, 10090
Actively Recruiting
79
Local Institution - 0153
Aalborg, North Denmark, Denmark, 9000
Not Yet Recruiting
80
Local Institution - 0154
Glostrup Municipality, Denmark, 2600
Not Yet Recruiting
81
Local Institution - 0170
Nice, Alpes-Maritimes, France, 06000
Not Yet Recruiting
82
Local Institution - 0171
Clermont-Ferrand, France, 63000
Not Yet Recruiting
83
Local Institution - 0172
Montpellier, France, 34295
Not Yet Recruiting
84
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, Hungary, 9024
Actively Recruiting
85
Local Institution - 0110
Budapest, Hungary, 0
Not Yet Recruiting
86
Semmelweis Egyetem
Budapest, Hungary, 1083
Actively Recruiting
87
Local Institution - 0111
Vadodara, Gujarat, India, 390021
Not Yet Recruiting
88
Local Institution - 0132
Belagavi, Karnataka, India, 590010
Not Yet Recruiting
89
Local Institution - 0159
Mangalore, Karnataka, India, 575003
Not Yet Recruiting
90
Local Institution - 0190
Mangaluru, Karnataka, India, 574143
Not Yet Recruiting
91
Local Institution - 0079
Kozhikode, Kerala, India, 673009
Not Yet Recruiting
92
Local Institution - 0077
Ludhiana, Punjab, India, 141001
Not Yet Recruiting
93
Local Institution - 0158
Madurai, Tamil Nadu, India, 625020
Not Yet Recruiting
94
Local Institution - 0078
Hyderabad, Telangana, India, 500034
Not Yet Recruiting
95
Local Institution - 0080
Hyderabad, Telangana, India, 500082
Not Yet Recruiting
96
Local Institution - 0076
Kolkata, West Bengal, India, 700014
Not Yet Recruiting
97
Local Institution - 0160
Kolkata, West Bengal, India, 700025
Not Yet Recruiting
98
Shalvata Mental Health Center
Hod HaSharon, Central District, Israel, 4534708
Actively Recruiting
99
Ness Ziona Mental Health Center
Ness Ziona, Central District, Israel, 7410001
Actively Recruiting
100
Local Institution - 0084
Petah Tikva, Central District, Israel, 4910002
Not Yet Recruiting
101
Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Actively Recruiting
102
Be'er Sheva Mental Health Center
Beersheba, Southern District, Israel, 8461144
Actively Recruiting
103
Local Institution - 0173
Ashkelon, Israel, 78306
Not Yet Recruiting
104
Local Institution - 0187
Bnei Brak, Israel, 5154475
Not Yet Recruiting
105
Local Institution - 0168
Jerusalem, Israel, 91120
Not Yet Recruiting
106
Kfar Shaul Mental Health Center
Jerusalem, Israel, 9546105
Actively Recruiting
107
Local Institution - 0066
Milan, Lombardy, Italy, 20122
Not Yet Recruiting
108
Local Institution - 0083
Pisa, Tuscany, Italy, 56126
Not Yet Recruiting
109
Local Institution - 0065
Siena, Tuscany, Italy, 53100
Not Yet Recruiting
110
Local Institution - 0070
Ancona, Italy, 60126
Not Yet Recruiting
111
Local Institution - 0069
Genova, Italy, 16132
Not Yet Recruiting
112
Hotei Hospital
Kōnan, Aichi-ken, Japan, 4838248
Actively Recruiting
113
Okehazama Hospital
Toyoake, Aichi-ken, Japan, 470-1168
Actively Recruiting
114
National Kohnodai Medical Center.
Ichikawa, Chiba, Japan, 272-8516
Actively Recruiting
115
Local Institution - 0166
Iizuka, Fukuoka, Japan, 820-8505
Withdrawn
116
Local Institution - 0063
Kitakyushu, Fukuoka, Japan, 803-0831
Withdrawn
117
Obihiro Kosei Hospital
Obihiro, Hokkaido, Japan, 080-0024
Actively Recruiting
118
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan, 002-8029
Actively Recruiting
119
Local Institution - 0165
Yokohama, Kanagawa, Japan, 234-0051
Not Yet Recruiting
120
Kansai Medical University Medical Center
Moriguchi, Osaka, Japan, 570-8507
Actively Recruiting
121
Local Institution - 0007
Sakai-shi, Osaka, Japan, 590-0018
Not Yet Recruiting
122
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, Japan, 847-0031
Actively Recruiting
123
Local Institution - 0016
Iruma, Saitama, Japan, 350-0495
Withdrawn
124
Saitama Konan Hospital
Kumagaya, Saitama, Japan, 360-0114
Actively Recruiting
125
Local Institution - 0163
Bunkyo-ku, Tokyo, Japan, 113-8431
Not Yet Recruiting
126
Nippon Medical School Hospital
Bunkyo-ku, Tokyo, Japan, 1138603
Actively Recruiting
127
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan, 187-8551
Actively Recruiting
128
Narimasu Kosei Hospital
tabashi City, Tokyo, Japan, 175-0091
Actively Recruiting
129
Kuramitsu Hospital
Fukuoka, Japan, 819-0037
Actively Recruiting
130
Kochi Health Sciences Center
Kochi, Japan, 781-8555
Actively Recruiting
131
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, Japan, 880-8510
Actively Recruiting
132
Osaka Metropolitan University Hospital
Osaka, Japan, 545-8586
Actively Recruiting
133
Showa Medical University Karasuyama Hospital
Tokyo, Japan, 157-8577
Actively Recruiting
134
Wakayama Medical University Hospital
Wakayama, Japan, 641-8510
Actively Recruiting
135
Yamagata Sakuracho Hospital
Yamagata, Japan, 990-0045
Actively Recruiting
136
North Shore Hospital
Auckland, New Zealand, 0622
Actively Recruiting
137
Centrum Medyczne HCP
Poznan, Greater Poland Voivodeship, Poland, 61-485
Actively Recruiting
138
Instytut Psychiatrii i Neurologii
Warsaw, Masovian Voivodeship, Poland, 02-957
Actively Recruiting
139
Klinika Psychiatrii Uniwersytet Medyczny w Białymstoku
Bialystok, Podlaskie Voivodeship, Poland, 15-272
Actively Recruiting
140
Local Institution - 0093
Gdansk, Pomeranian Voivodeship, Poland, 80-214
Not Yet Recruiting
141
M2M Med
Rybnik, Silesian Voivodeship, Poland, 44-200
Actively Recruiting
142
Clinica Inventiva
Tuszyn, Poland, 95-080
Actively Recruiting
143
Local Institution - 0095
Bucharest, Bucharest, Romania, 041914
Not Yet Recruiting
144
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
145
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
146
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
147
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
148
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
149
Local Institution - 0167
Bucharest, Romania, 011241
Not Yet Recruiting
150
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
Bucharest, Romania, 060222
Actively Recruiting
151
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
Bucharest, Romania, 0
Actively Recruiting
152
Local Institution - 0097
Iași, Romania, 700282
Not Yet Recruiting
153
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, Romania, 507190
Actively Recruiting
154
Local Institution - 0118
Košice, Košice Region, Slovakia, 040 01
Not Yet Recruiting
155
Local Institution - 0119
Košice, Košice Region, Slovakia, 040 01
Not Yet Recruiting
156
Local Institution - 0117
Vranov nad Topľou, Presov, Slovakia, 093 01
Not Yet Recruiting
157
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
158
Osi Bilbao-Basurto
Bilbao, Basque Country, Spain, 48013
Actively Recruiting
159
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain, 08036
Actively Recruiting
160
Nacka Local Hospital
Nacka, Stockholms Län [se-01], Sweden, 131 45
Actively Recruiting
161
Local Institution - 0112
Uppsala, Uppsala Län [se-03], Sweden, 751 85
Withdrawn
162
Local Institution - 0116
Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
Withdrawn
163
Local Institution - 0152
Smila, Cherkasy Oblast, Ukraine, 20708
Not Yet Recruiting
164
Local Institution - 0146
Skarzhyntsi, Khmelnytskyi Oblast, Ukraine, 32120
Not Yet Recruiting
165
Local Institution - 0143
Hlevakha, Kyivska Oblast, Ukraine, 08631
Not Yet Recruiting
166
Local Institution - 0147
Lviv, Lviv Oblast, Ukraine, 79021
Not Yet Recruiting
167
Local Institution - 0145
Oleksandrivka, Odesa Oblast, Ukraine, 67513
Not Yet Recruiting
168
Local Institution - 0189
Ternopil, Ternopil Oblast, Ukraine, 460027
Not Yet Recruiting
169
Local Institution - 0148
Vinnytsia, Vinnytsia Oblast, Ukraine, 21037
Not Yet Recruiting
170
Local Institution - 0149
Dnipro, Ukraine, 49115
Not Yet Recruiting
171
Local Institution - 0151
Kropyvnytskyi, Ukraine, 25491
Not Yet Recruiting
172
Local Institution - 0150
Kyiv, Ukraine, 04080
Not Yet Recruiting
173
Local Institution - 0141
Poltava, Ukraine, 36013
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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First line of the email MUST contain NCT # and Site #.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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