Actively Recruiting
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Led by Bristol-Myers Squibb · Updated on 2026-04-29
274
Participants Needed
74
Research Sites
72 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a Phase 3, randomized, double-blind, placebo-controlled, multicenter, inpatient study in participants with bipolar disorder experiencing an acute episode of mania or mania with mixed features. The primary objective of the study is to evaluate the efficacy of KarXT compared to placebo in treating symptoms of mania during a 3-week inpatient period. The duration of the study including screening, the double-blind inpatient treatment period and safety-follow-up is no more than seven weeks.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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, including BP-I with depression (for previous 3 months only), BP-II disorder, borderline personality disorder, major depressive disorder, and primary psychotic disorder, except 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 or alcohol test.
- Participants must not be at risk for suicidal behavior at screening or baseline as determined by clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
- Participants must not have cirrhosis, liver cancer, or clinically significant liver disease based on liver function tests.
- Other protocol-defined Inclusion/Exclusion criteria apply.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 74 locations
1
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States, 72204
Actively Recruiting
2
Woodland Research Northwest
Rogers, Arkansas, United States, 72758
Actively Recruiting
3
Proscience Research Group
Culver City, California, United States, 90230
Actively Recruiting
4
Clinical Innovations, Inc. dba CITrials
Riverside, California, United States, 92506
Actively Recruiting
5
Collaborative Neuroscience Research, LLC
Torrance, California, United States, 90502
Actively Recruiting
6
Local Institution - 0036
Hialeah Gardens, Florida, United States, 33016
Withdrawn
7
Behavioral Clinical Research
Hollywood, Florida, United States, 33021
Actively Recruiting
8
LCC Medical Research Institute
Miami, Florida, United States, 33126
Actively Recruiting
9
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States, 33016
Actively Recruiting
10
South Florida Research Phase I-IV
Miami Springs, Florida, United States, 33166
Actively Recruiting
11
Local Institution - 0019
Tampa, Florida, United States, 33618
Withdrawn
12
Health Synergy Clinical Research
West Palm Beach, Florida, United States, 33407
Actively Recruiting
13
Atlanta Center for Medical Research
Atlanta, Georgia, United States, 30331
Actively Recruiting
14
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
15
Local Institution - 0020
Chicago, Illinois, United States, 60640
Not Yet Recruiting
16
CBH Health
Gaithersburg, Maryland, United States, 20877
Actively Recruiting
17
Precise Research Centers
Flowood, Mississippi, United States, 39232
Actively Recruiting
18
Arch Clinical Trials
St Louis, Missouri, United States, 63141
Actively Recruiting
19
Local Institution - 0076
North Las Vegas, Nevada, United States, 89030
Withdrawn
20
Hassman Research Institute Marlton Site
Marlton, New Jersey, United States, 08053
Actively Recruiting
21
Local Institution - 0031
Marlton, New Jersey, United States, 08053
Withdrawn
22
Local Institution - 0075
Charlotte, North Carolina, United States, 28211
Withdrawn
23
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
Actively Recruiting
24
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States, 44720
Actively Recruiting
25
InSite Clinical Research
DeSoto, Texas, United States, 75115
Actively Recruiting
26
Local Institution - 0028
Houston, Texas, United States, 77021
Withdrawn
27
Pillar Clinical Research - Richardson
Richardson, Texas, United States, 75080
Actively Recruiting
28
Local Institution - 0009
Zagreb, City of Zagreb, Croatia, 10090
Withdrawn
29
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia, 10090
Actively Recruiting
30
Klinika za psihijatriju "Vrapče"
Zagreb, Croatia, 10090
Actively Recruiting
31
Local Institution - 0078
Zagreb, Croatia, 10090
Not Yet Recruiting
32
Psihijatrijska bolnica "Sveti Ivan"
Zagreb, Croatia, 10090
Actively Recruiting
33
Local Institution - 0065
Vadodara, Gujarat, India, 390021
Not Yet Recruiting
34
Local Institution - 0082
Belagavi, Karnataka, India, 590010
Not Yet Recruiting
35
Local Institution - 0053
Kozhikode, Kerala, India, 673009
Not Yet Recruiting
36
Local Institution - 0051
Ludhiana, Punjab, India, 141001
Not Yet Recruiting
37
Local Institution - 0052
Hyderabad, Telangana, India, 500034
Not Yet Recruiting
38
Local Institution - 0055
Hyderabad, Telangana, India, 500082
Not Yet Recruiting
39
Local Institution - 0054
Kolkata, West Bengal, India, 700014
Not Yet Recruiting
40
Shalvata Mental Health Center
Hod HaSharon, Central District, Israel, 4534708
Actively Recruiting
41
Ness Ziona Mental Health Center
Ness Ziona, Central District, Israel, 7410001
Actively Recruiting
42
Local Institution - 0058
Petah Tikva, Central District, Israel, 4910002
Not Yet Recruiting
43
Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Actively Recruiting
44
Be'er Sheva Mental Health Center
Beersheba, Southern District, Israel, 8461144
Actively Recruiting
45
Kfar Shaul Mental Health Center
Jerusalem, Israel, 9546105
Actively Recruiting
46
Local Institution - 0001
Milan, Lombardy, Italy, 20122
Withdrawn
47
Local Institution - 0056
Pisa, Tuscany, Italy, 56126
Withdrawn
48
Local Institution - 0007
Siena, Tuscany, Italy, 53100
Withdrawn
49
Local Institution - 0041
Ancona, Italy, 60126
Withdrawn
50
Local Institution - 0040
Genova, Italy, 16132
Withdrawn
51
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
52
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
53
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
54
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
55
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
56
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
57
Centrul de Evaluare și Tratament a Toxicodependenței pentru Tineri Sf.Stelian
Bucharest, Romania, 060222
Actively Recruiting
58
Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila
Bucharest, Romania, 0
Actively Recruiting
59
Local Institution - 0047
Iași, Romania, 700282
Not Yet Recruiting
60
Spitalul de Psihiatrie și Neurologie Brașov
Sanpetru /Brasov, Romania, 507190
Actively Recruiting
61
Local Institution - 0071
Košice, Košice Region, Slovakia, 040 01
Not Yet Recruiting
62
Local Institution - 0073
Košice, Košice Region, Slovakia, 040 01
Not Yet Recruiting
63
Local Institution - 0072
Vranov nad Topľou, Presov, Slovakia, 093 01
Not Yet Recruiting
64
Hospital Universitari Vall d'Hebron
Barcelona, Barcelona [Barcelona], Spain, 08035
Actively Recruiting
65
Osi Bilbao-Basurto
Bilbao, Basque Country, Spain, 48013
Actively Recruiting
66
Hospital Clínic de Barcelona
Barcelona, Catalunya [Cataluña], Spain, 08036
Actively Recruiting
67
Nacka Local Hospital
Nacka, Stockholms Län [se-01], Sweden, 131 45
Actively Recruiting
68
Local Institution - 0067
Uppsala, Uppsala Län [se-03], Sweden, 751 85
Withdrawn
69
Local Institution - 0070
Gothenburg, Västra Götalands Län [se-14], Sweden, 413 45
Withdrawn
70
Local Institution - 0088
Dnipro, Dnipropetrovsk Oblast, Ukraine, 49115
Not Yet Recruiting
71
Local Institution - 0092
Hlevakha, Kyiv Oblast, Ukraine, 08631
Not Yet Recruiting
72
Local Institution - 0093
Oleksandrivka, Odesa Oblast, Ukraine, 67513
Not Yet Recruiting
73
Local Institution - 0085
Vinnytsia, Vinnytsia Oblast, Ukraine, 21037
Not Yet Recruiting
74
Local Institution - 0094
Odesa, Ukraine, 65006
Not Yet Recruiting
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
F
First line of the email MUST contain NCT # and Site #.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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