A Phase 3, Randomized, Two-part Study With a 5-week Double-blind Part (Randomized, Parallelgroup, Placebo-controlled) Followed by a 52-week Open-label Extension Part to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Patients With Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) Schizophrenia
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Participants must have a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the Diagnostic and Statistical Manual of Mental Disorders⎯Fifth Edition (DSM-5) criteria and confirmed by Mini International Neuropsychiatric Interview (MINI).
• Participants must have a PANSS total score between 80 and 120, inclusive.
• Participants must have a CGI-S score of ≥ 4.
Locations
Other Locations
Japan
Takeda General Hospital - Aizuwakamatsu
RECRUITING
Aizu-wakamatsu
Kuramitsu Hospital
RECRUITING
Fukuoka
Local Institution - 0051
NOT_YET_RECRUITING
Ginowan
Local Institution - 0012
WITHDRAWN
Hachiōji
Local Institution - 0025
NOT_YET_RECRUITING
Hadano-shi
Osaka Psychiatric Medical Center
RECRUITING
Hirakata
Fujimidai Hospital
RECRUITING
Hiratsuka
National Kohnodai Medical Center.
RECRUITING
Ichikawa
Local Institution - 0032
NOT_YET_RECRUITING
Iizuka
Rainbow and Sea Hospital
RECRUITING
Karatsu-shi
Local Institution - 0037
NOT_YET_RECRUITING
Kitakyushu
National Center of Neurology and Psychiatry
RECRUITING
Kodaira
Local Institution - 0014
WITHDRAWN
Komoro
Hotei Hospital
RECRUITING
Kōnan
Saitama Konan Hospital
RECRUITING
Kumagaya
Yuge Hospital
RECRUITING
Kumamoto
Kure Medical Center
RECRUITING
Kure
University Hospital,Kyoto Prefectural University of Medicine
RECRUITING
Kyoto
Asuka Hospital
RECRUITING
Machida
National Hospital Organization Maizuru Medical Center
RECRUITING
Maizuru
Local Institution - 0050
NOT_YET_RECRUITING
Matsumoto
National Hospital Organization Shimofusa Psychiatric Medical Center
RECRUITING
Midori-ku, Chiba-shi
Miyakonojo Shinsei Hospital
RECRUITING
Miyakonojō
Local Institution - 0029
NOT_YET_RECRUITING
Miyazaki
Kansai Medical University Medical Center
RECRUITING
Moriguchi
Local Institution - 0056
NOT_YET_RECRUITING
Nagoya
Nagaokai Medical Corporation - Neyagawa Sanatorium
RECRUITING
Neyagawa
Local Institution - 0055
NOT_YET_RECRUITING
Okayama
Local Institution - 0018
NOT_YET_RECRUITING
Okinawa
Shiranui Hospital
RECRUITING
Omuta
Local Institution - 0031
NOT_YET_RECRUITING
Osaka
Local Institution - 0053
NOT_YET_RECRUITING
Ōta-ku
Local Institution - 0052
NOT_YET_RECRUITING
Sagamihara
Saitama Neuropsychitric Institute
RECRUITING
Saitama
Goryokai Medical Corporation - Goryokai Hospital
RECRUITING
Sapporo
Hokkaido University Hospital
RECRUITING
Sapporo
Tokyo Metropolitan Matsuzawa Hospital
RECRUITING
Setagaya City
Dokkyo Medical University Hospital
RECRUITING
Shimotsuga
Narimasu Kosei Hospital
RECRUITING
Tabashi City
Osaka Medical and Pharmaceutical University Hospital
RECRUITING
Takatsuki
Shin-Abuyama Hospital
RECRUITING
Takatsuki
Local Institution - 0044
NOT_YET_RECRUITING
Toki
Local Institution - 0039
NOT_YET_RECRUITING
Tokushima
Inuo Hospital
RECRUITING
Tosu
Local Institution - 0033
WITHDRAWN
Tottori
Fujita Health University
RECRUITING
Toyoake
Okehazama Hospital
RECRUITING
Toyoake
Yamaguchi University Hospital
RECRUITING
Ube
Local Institution - 0043
NOT_YET_RECRUITING
Utsunomiya
Wakayama Medical University Hospital
RECRUITING
Wakayama
Yamagata Sakuracho Hospital
RECRUITING
Yamagata
Local Institution - 0019
WITHDRAWN
Yatsushiro
Hino Hospital - Yokohama
RECRUITING
Yokohama
Local Institution - 0028
NOT_YET_RECRUITING
Yokohama
Tsurumi Nishii Hospital
RECRUITING
Yokohama
Contact Information
Primary
BMS Study Connect www.BMSStudyConnect.com
Clinical.Trials@bms.com
8559073286
Backup
First line of the email MUST contain the NCT# and Site#
Time Frame
Start Date: 2025-06-10
Estimated Completion Date: 2029-08-23
Participants
Target number of participants: 250
Treatments
Active_comparator: Administration of KarXT
Placebo_comparator: Placebo
Related Therapeutic Areas
Sponsors
Leads: Bristol-Myers Squibb