Actively Recruiting
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
Led by Bristol-Myers Squibb · Updated on 2026-04-30
424
Participants Needed
103
Research Sites
89 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Bipolar-I disorder confirmed by psychiatric evaluation and MINI version 7.0.2
- Experiencing an acute manic episode, with or without mixed features, lasting 3 weeks or less
- Requires hospitalization for the manic episode
- Body mass index between 18 and 40 kg/m2
- Currently on a stable, therapeutic dose of lithium, valproate, or lamotrigine for at least 2 weeks; valproate treatment for at least 7 months
- Young Mania Rating Scale score of 18 or higher at screening and baseline, with less than 20% improvement between screening and baseline
You will not qualify if you...
- Diagnosis of any primary DSM-5-TR disorder other than Bipolar-I within 12 months before screening, except mild anxiety disorders
- Moderate to severe substance use disorder (except tobacco) within 12 months before screening or current use
- Risk of suicidal behavior as determined by clinical assessment and C-SSRS within 6 months before screening or between screening and baseline
- History of irritable bowel syndrome or serious constipation requiring treatment within last 6 months
- History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma
- HIV, cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, or active hepatic viral infections
- Elevated liver enzymes at screening (ALT or AST ≥ 2 times upper limit of normal or bilirubin > 1.5 times upper limit), except Gilbert's syndrome
- Any grade of hepatic impairment (mild, moderate, or severe)
- 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: 103 locations
1
Pillar Clinical Research - Bentonville
Bentonville, Arkansas, United States, 72712
Actively Recruiting
2
Pillar Clinical Research- Little Rock
Little Rock, Arkansas, United States, 72204
Actively Recruiting
3
Clinical Innovations, Inc. dba CITrials
Bellflower, California, United States, 90706
Actively Recruiting
4
Inland Psychiatric Medical Group.
Chino, California, United States, 91710
Actively Recruiting
5
Proscience Research Group
Culver City, California, United States, 90230
Actively Recruiting
6
Omega Clinical Trials - La Habra
La Habra, California, United States, 90631
Actively Recruiting
7
Catalina Research Institute, LLC
Montclair, California, United States, 91763
Actively Recruiting
8
NRC Research Institute
Orange, California, United States, 92868
Actively Recruiting
9
Clinical Innovations, Inc. dba CITrials
Riverside, California, United States, 92506
Actively Recruiting
10
Velocity Clinical Research, Hallandale Beach
Hallandale, Florida, United States, 33009
Actively Recruiting
11
South Florida Research Phase I-IV
Miami, Florida, United States, 33166
Actively Recruiting
12
Health Synergy Clinical Research
West Palm Beach, Florida, United States, 33407
Actively Recruiting
13
CenExel iResearch, LLC
Savannah, Georgia, United States, 31405
Actively Recruiting
14
Pillar Clinical Research -Chicago
Chicago, Illinois, United States, 60641
Actively Recruiting
15
Arch Clinical Trials
St Louis, Missouri, United States, 63141
Actively Recruiting
16
Richmond Behavioral Associates
Staten Island, New York, United States, 10314
Actively Recruiting
17
Community Clinical Research
Austin, Texas, United States, 78754
Actively Recruiting
18
Local Institution - 0160
Houston, Texas, United States, 77058
Not Yet Recruiting
19
Prime Clinical Research - Mansfield
Mansfield, Texas, United States, 76063
Actively Recruiting
20
Pillar Clinical Research - Richardson
Richardson, Texas, United States, 75080
Actively Recruiting
21
Local Institution - 0011
ABB, Buenos Aires F.D., Argentina, C1199ABB
Not Yet Recruiting
22
Local Institution - 0010
Córdoba, Argentina, 5000
Not Yet Recruiting
23
Local Institution - 0012
Córdoba, Argentina, 5000
Not Yet Recruiting
24
Local Institution - 0008
Córdoba, Argentina, X5003DCE
Not Yet Recruiting
25
Local Institution - 0009
Mendoza, Argentina, 5502
Not Yet Recruiting
26
Local Institution - 0114
Santiago del Estero, Argentina, 4200
Not Yet Recruiting
27
Local Institution - 0184
Kazanlak, Stara Zagora, Bulgaria, 6100
Not Yet Recruiting
28
Local Institution - 0124
Novi Iskar, Bulgaria, 1282
Not Yet Recruiting
29
"University Multiprofile Hospital for Active Treatment - Dr. Georgi Stranski" EAD
Pleven, Bulgaria, 5800
Actively Recruiting
30
Local Institution - 0084
Pleven, Bulgaria, 5800
Not Yet Recruiting
31
Local Institution - 0181
Sliven, Bulgaria, 8800
Not Yet Recruiting
32
Local Institution - 0086
Targovishte, Bulgaria, 7700
Not Yet Recruiting
33
Local Institution - 0185
Beijing, Beijing Municipality, China, 100088
Not Yet Recruiting
34
Local Institution - 0190
Beijing, Beijing Municipality, China, 100096
Not Yet Recruiting
35
Local Institution - 0191
Guangzhou, Guangdong, China, 510370
Not Yet Recruiting
36
Local Institution - 0193
Baoding, Hebei, China, 71000
Not Yet Recruiting
37
Local Institution - 0187
Shijiazhuang, Hebei, China, 050031
Not Yet Recruiting
38
Local Institution - 0196
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
39
Local Institution - 0186
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
40
Local Institution - 0192
Chengdu, Sichuan, China, 610036
Not Yet Recruiting
41
Local Institution - 0188
Tianjin, Tianjin Municipality, China, 300022
Not Yet Recruiting
42
Local Institution - 0197
Ningbo, Zhejiang, China, 315201
Not Yet Recruiting
43
Local Institution - 0195
Changsha, China, 450052
Not Yet Recruiting
44
Local Institution - 0088
Hillerød, Capital Region, Denmark, 3400
Not Yet Recruiting
45
Local Institution - 0054
Aalborg, North Denmark, Denmark, 9000
Not Yet Recruiting
46
Local Institution - 0091
Glostrup Municipality, Denmark, 2600
Not Yet Recruiting
47
Local Institution - 0126
Nice, Alpes-Maritimes, France, 06000
Not Yet Recruiting
48
Local Institution - 0085
Clermont-Ferrand, Puy-de-Dôme, France, 63000
Not Yet Recruiting
49
Local Institution - 0087
Marseille, France, 13274
Withdrawn
50
Local Institution - 0129
Montpellier, France, 34295
Not Yet Recruiting
51
Local Institution - 0089
Paris, France, 75014
Withdrawn
52
Local Institution - 0121
Mangalore, Karnataka, India, 575003
Not Yet Recruiting
53
Local Institution - 0123
Madurai, Tamil Nadu, India, 625020
Not Yet Recruiting
54
Local Institution - 0118
Kolkata, West Bengal, India, 700025
Not Yet Recruiting
55
Local Institution - 0116
Kolkata, India, 700014
Not Yet Recruiting
56
Local Institution - 0052
Hod HaSharon, Central District, Israel, 4534708
Not Yet Recruiting
57
Sheba Medical Center
Ramat Gan, Central District, Israel, 5265601
Actively Recruiting
58
Local Institution - 0053
Ashkelon, Southern District, Israel, 7830604
Not Yet Recruiting
59
Local Institution - 0199
Beersheba, Southern District, Israel, 8461144
Not Yet Recruiting
60
Local Institution - 0200
Bnei Brak, Israel, 5154475
Not Yet Recruiting
61
Local Institution - 0083
Jerusalem, Israel, 9112001
Not Yet Recruiting
62
Local Institution - 0003
Milan, Lombardy, Italy, 20122
Not Yet Recruiting
63
Local Institution - 0005
Pisa, Tuscany, Italy, 56126
Not Yet Recruiting
64
Local Institution - 0001
Siena, Tuscany, Italy, 53100
Not Yet Recruiting
65
Local Institution - 0004
Ancona, Italy, 60126
Not Yet Recruiting
66
Local Institution - 0002
Genova, Italy, 16132
Not Yet Recruiting
67
Okehazama Hospital
Toyoake, Aichi-ken, Japan, 470-1168
Actively Recruiting
68
Local Institution - 0205
Ichikawa, Chiba, Japan, 272-8516
Not Yet Recruiting
69
Local Institution - 0172
Iizuka, Fukuoka, Japan, 820-8505
Withdrawn
70
Local Institution - 0141
Kitakyushu-shi, Fukuoka, Japan, 8078555
Withdrawn
71
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan, 002-8029
Actively Recruiting
72
Local Institution - 0107
Yokohama, Kanagawa, Japan, 234-0051
Not Yet Recruiting
73
Rainbow and Sea Hospital
Karatsu, Saga-ken, Japan, 847-0031
Actively Recruiting
74
Local Institution - 0180
Bunkyo-ku, Tokyo, Japan, 113-8431
Not Yet Recruiting
75
Local Institution - 0139
Bunkyo-ku, Tokyo, Japan, 1138603
Not Yet Recruiting
76
Local Institution - 0201
Kodaira, Tokyo, Japan, 187-8551
Not Yet Recruiting
77
Local Institution - 0176
tabashi City, Tokyo, Japan, 175-0091
Not Yet Recruiting
78
Kuramitsu Hospital
Fukuoka, Japan, 819-0037
Actively Recruiting
79
Kochi Health Sciences Center
Kochi, Japan, 781-8555
Actively Recruiting
80
Local Institution - 0103
Rybnik, Silesian Voivodeship, Poland, 44-200
Not Yet Recruiting
81
Clinica Inventiva
Tuszyn, Poland, 95-080
Actively Recruiting
82
Local Institution - 0093
Bucharest, Bucharest, Romania, 041914
Not Yet Recruiting
83
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
84
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
85
Prof. Dr. Alexandru Obregia Psychiatry Hospital
Bucharest, Bucharest, Romania, 041914
Actively Recruiting
86
Local Institution - 0102
Bucharest, Romania, 011241
Not Yet Recruiting
87
Local Institution - 0099
Bucharest, Romania, 0
Not Yet Recruiting
88
Local Institution - 0203
Bucharest, Romania, 41914
Not Yet Recruiting
89
Local Institution - 0097
Iași, Romania, 700282
Not Yet Recruiting
90
Local Institution - 0095
Sanpetru /Brasov, Romania, 507190
Not Yet Recruiting
91
Local Institution - 0101
Sibiu, Romania, 550082
Not Yet Recruiting
92
Local Institution - 0167
Smila, Cherkasy Oblast, Ukraine, 20708
Not Yet Recruiting
93
Local Institution - 0165
Dnipro, Dnipropetrovsk Oblast, Ukraine, 49005
Not Yet Recruiting
94
Local Institution - 0178
Skarzhyntsi, Khmelnytskyi Oblast, Ukraine, 32120
Not Yet Recruiting
95
Local Institution - 0163
Nove, Kirovohrad Oblast, Ukraine, 25491
Not Yet Recruiting
96
Local Institution - 0169
Hlevakha, Kyivska Oblast, Ukraine, 08631
Not Yet Recruiting
97
Local Institution - 0162
Kyiv, Kyivska Oblast, Ukraine, 04080
Not Yet Recruiting
98
Local Institution - 0164
Lviv, Lviv Oblast, Ukraine, 79021
Not Yet Recruiting
99
Local Institution - 0206
Ternopil, Ternopil Oblast, Ukraine, 460027
Not Yet Recruiting
100
Local Institution - 0168
Vinnytsia, Vinnytsia Oblast, Ukraine, 21037
Not Yet Recruiting
101
Local Institution - 0170
Odesa, Ukraine, 65006
Not Yet Recruiting
102
Local Institution - 0171
Odesa, Ukraine, 65006
Not Yet Recruiting
103
Local Institution - 0177
Poltava, Ukraine, 36000
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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