A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder
NCT ID: NCT06951698
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
274 participants
INTERVENTIONAL
2025-06-11
2026-11-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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KarXT
Flexible dosing
KarXT
Specified dose on specified days
Placebo
Placebo
Specified dose on specified days
Interventions
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KarXT
Specified dose on specified days
Placebo
Specified dose on specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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 screen or alcohol test.
* Participants must not be at risk for suicidal behavior at screening or the baseline visit as determined by the Investigator's clinical assessment and the Columbia-Suicide Severity Rating Scale (C-SSRS).
* Participants must not have a history of irritable bowel syndrome (with or without constipation) or serious constipation requiring treatment within the last 6 months.
* Participants must not have a history or high risk of urinary retention, gastric retention, or untreated narrow-angle glaucoma.
18 Years
65 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Pillar Clinical Research - Bentonville
Bentonville, Arkansas, United States
Woodland International Research Group
Little Rock, Arkansas, United States
Advanced Research Center Inc.
Anaheim, California, United States
CITrials
Bellflower, California, United States
Local Institution - 0014
Cerritos, California, United States
Collaborative Neuroscience Research, LLC
Long Beach, California, United States
Catalina Research Institute, LLC
Montclair, California, United States
NRC Research Institute
Orange, California, United States
Local Institution - 0124
New Haven, Connecticut, United States
Health Synergy Clinical Research
Boynton Beach, Florida, United States
Research Centers of America ( Hollywood )
Hollywood, Florida, United States
Advanced Research Institute of Miami
Homestead, Florida, United States
Innovative Clinical Research, Inc.
Miami Lakes, Florida, United States
Local Institution - 0015
Miami Lakes, Florida, United States
South Florida Research Phase I-IV
Miami Springs, Florida, United States
Synexus Clinical Research US, Inc.
Atlanta, Georgia, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Pillar Clinical Research -Chicago
Chicago, Illinois, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Neuro-Behavioral Clinical Research
North Canton, Ohio, United States
Local Institution - 0029
Irving, Texas, United States
Pillar Clinical Research - Richardson
Richardson, Texas, United States
Local Institution - 0110
ABB, Buenos Aires F.D., Argentina
Local Institution - 0115
Córdoba, , Argentina
Local Institution - 0108
Mendoza, , Argentina
Local Institution - 0109
Mendoza, , Argentina
Ramsay Clinic Northside
St Leonards, New South Wales, Australia
Ramsay Clinic New Farm
Brisbane, Queensland, Australia
Center for Mental Health Prof. Dr. Ivan Temkov
Burgas, , Bulgaria
Local Institution - 0119
Novi Iskar, , Bulgaria
Local Institution - 0112
Pleven, , Bulgaria
Local Institution - 0120
Sliven, , Bulgaria
Local Institution - 0121
Vratsa, , Bulgaria
Petz Aladar Egyetemi Oktato Korhaz
Győr, Győr-Moson-Sopron, Hungary
Local Institution - 0114
Budapest, , Hungary
Semmelweis Egyetem
Budapest, , Hungary
Local Institution - 0082
Kōnan, Aichi-ken, Japan
Okehazama Hospital
Toyoake, Aichi-ken, Japan
National Kohnodai Medical Center.
Ichikawa, Chiba, Japan
Local Institution - 0100
Kitakyushu, Fukuoka, Japan
Obihiro Kosei Hospital
Obihiro, Hokkaido, Japan
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan
Kansai Medical University Medical Center
Moriguchi, Osaka, Japan
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, Japan
Local Institution - 0081
Iruma, Saitama, Japan
Saitama Konan Hospital
Kumagaya, Saitama, Japan
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan
Narimasu Kosei Hospital
tabashi City, Tokyo, Japan
Kuramitsu Hospital
Fukuoka, , Japan
Local Institution - 0077
Miyazaki, , Japan
Osaka Metropolitan University Hospital
Osaka, , Japan
Local Institution - 0084
Osaka, , Japan
Showa Medical University Karasuyama Hospital
Tokyo, , Japan
Wakayama Medical University Hospital
Wakayama, , Japan
Yamagata Sakuracho Hospital
Yamagata, , Japan
Local Institution - 0055
Auckland, , New Zealand
Local Institution - 0095
Poznan, Greater Poland Voivodeship, Poland
Local Institution - 0107
Warsaw, Masovian Voivodeship, Poland
Local Institution - 0094
Bialystok, Podlaskie Voivodeship, Poland
Local Institution - 0111
Gdansk, Pomeranian Voivodeship, Poland
Local Institution - 0103
Rybnik, Silesian Voivodeship, Poland
Local Institution - 0102
Sosnowiec, Silesian Voivodeship, Poland
Local Institution - 0096
Tuszyn, Łódź Voivodeship, Poland
Countries
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Central Contacts
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First line of the email MUST contain the NCT# and Site#
Role: CONTACT
Facility Contacts
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Fayz Hudefi, Site 0058
Role: primary
George Konis, Site 0011
Role: primary
Steven Macina, Site 0005
Role: primary
Robert Bota, Site 0008
Role: primary
Site 0014
Role: primary
David Walling, Site 0059
Role: primary
Stephen Volk, Site 0072
Role: primary
Tony Ortiz, Site 0053
Role: primary
Site 0124
Role: primary
Mohammad Nisar, Site 0023
Role: primary
Edwin Gomez, Site 0043
Role: primary
Moraima Trujillo, Site 0020
Role: primary
Rishi Kakar, Site 0054
Role: primary
Site 0015
Role: primary
Silvia Silva Duluc, Site 0069
Role: primary
Bethany Davis, Site 0009
Role: primary
Michael Mobley, Site 0057
Role: primary
Roueen Rafeyan, Site 0047
Role: primary
Peter Weiden, Site 0030
Role: primary
Shishuka Malhotra, Site 0013
Role: primary
Scott Bartley, Site 0044
Role: primary
Site 0110
Role: primary
Site 0115
Role: primary
Site 0108
Role: primary
Site 0109
Role: primary
Philip Mitchell, Site 0117
Role: primary
James Scott, Site 0106
Role: primary
Veselin Palazov, Site 0113
Role: primary
Site 0119
Role: primary
Site 0112
Role: primary
Site 0120
Role: primary
Site 0121
Role: primary
Gabor Feller, Site 0116
Role: primary
Site 0114
Role: primary
János Réthelyi, Site 0118
Role: primary
Site 0082
Role: primary
kiyoshi Fujita, Site 0079
Role: primary
Toshihiko Ito, Site 0078
Role: primary
Kengo Furuse, Site 0090
Role: primary
Kimihiro Nakajima, Site 0080
Role: primary
Masaki Kato, Site 0089
Role: primary
Taro Shindo, Site 0087
Role: primary
Narifumi Yokoyama, Site 0092
Role: primary
Takamasa Noda, Site 0105
Role: primary
Yuya Tenjin, Site 0085
Role: primary
Noriko Tamaru, Site 0083
Role: primary
Site 0077
Role: primary
Yasuhiko Deguchi, Site 0086
Role: primary
Site 0084
Role: primary
Kenji Sanada, Site 0104
Role: primary
Sohei Kimoto, Site 0076
Role: primary
Nobuhiro Yokokawa, Site 0088
Role: primary
Site 0055
Role: primary
Site 0095
Role: primary
Site 0107
Role: primary
Site 0094
Role: primary
Site 0111
Role: primary
Site 0103
Role: primary
Site 0102
Role: primary
Site 0096
Role: primary
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Other Identifiers
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2024-520165-32
Identifier Type: OTHER
Identifier Source: secondary_id
U1111-1316-7438
Identifier Type: OTHER
Identifier Source: secondary_id
CN012-0036
Identifier Type: -
Identifier Source: org_study_id