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A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Sponsor: Bristol-Myers Squibb
Summary
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2025-06-10
Completion Date
2029-08-23
Last Updated
2026-03-17
Healthy Volunteers
No
Conditions
Interventions
KarXT
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (55)
Hotei Hospital
Kōnan, Aichi-ken, Japan
Local Institution - 0056
Nagoya, Aichi-ken, Japan
Okehazama Hospital
Toyoake, Aichi-ken, Japan
Fujita Health University
Toyoake, Aichi-ken, Japan
National Kohnodai Medical Center.
Ichikawa, Chiba, Japan
National Hospital Organization Shimofusa Psychiatric Medical Center
MIdori-ku, Chiba-shi, Chiba, Japan
Local Institution - 0032
Iizuka, Fukuoka, Japan
Local Institution - 0037
Kitakyushu, Fukuoka, Japan
Shiranui Hospital
Omuta, Fukuoka, Japan
Takeda General Hospital - Aizuwakamatsu
Aizu-Wakamatsu, Fukushima, Japan
Local Institution - 0044
Toki, Gifu, Japan
Kure Medical Center
Kure, Hiroshima, Japan
Goryokai Medical Corporation - Goryokai Hospital
Sapporo, Hokkaido, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Local Institution - 0025
Hadano-shi, Kanagawa, Japan
Fujimidai Hospital
Hiratsuka, Kanagawa, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, Japan
Tsurumi Nishii Hospital
Yokohama, Kanagawa, Japan
Yokohama City University Medical Center
Yokohama, Kanagawa, Japan
Hino Hospital - Yokohama
Yokohama, Kanagawa, Japan
Yuge Hospital
Kumamoto, Kumamoto, Japan
Local Institution - 0019
Yatsushiro, Kumamoto, Japan
National Hospital Organization Maizuru Medical Center
Maizuru, Kyoto, Japan
Miyakonojo Shinsei Hospital
Miyakonojō, Miyazaki, Japan
Local Institution - 0014
Komoro, Nagano, Japan
Local Institution - 0050
Matsumoto, Nagano, Japan
University of the Ryukyus Hospital
Ginowan, Okinawa, Japan
Osaka Psychiatric Medical Center
Hirakata, Osaka, Japan
Kansai Medical University Medical Center
Moriguchi, Osaka, Japan
Nagaokai Medical Corporation - Neyagawa Sanatorium
Neyagawa, Osaka, Japan
Shin-Abuyama Hospital
Takatsuki, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Rainbow and Sea Hospital
Karatsu-shi, Saga-ken, Japan
Inuo Hospital
Tosu, Saga-ken, Japan
Saitama Konan Hospital
Kumagaya, Saitama, Japan
Dokkyo Medical University Hospital
Shimotsuga, Tochigi, Japan
Local Institution - 0043
Utsunomiya, Tochigi, Japan
Local Institution - 0012
Hachiōji, Tokyo, Japan
National Center of Neurology and Psychiatry
Kodaira, Tokyo, Japan
Asuka Hospital
Machida, Tokyo, Japan
Toho University Omori Medical Center
Ōta-ku, Tokyo, Japan
Tokyo Metropolitan Matsuzawa Hospital
Setagaya City, Tokyo, Japan
Narimasu Kosei Hospital
tabashi City, Tokyo, Japan
Yamaguchi University Hospital
Ube, Yamaguchi, Japan
Kuramitsu Hospital
Fukuoka, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Japan
Miyazaki Prefectural Miyazaki Hospital
Miyazaki, Japan
Local Institution - 0055
Okayama, Japan
Local Institution - 0018
Okinawa, Japan
Local Institution - 0031
Osaka, Japan
Saitama Neuropsychitric Institute
Saitama, Japan
Local Institution - 0039
Tokushima, Japan
Local Institution - 0033
Tottori, Japan
Wakayama Medical University Hospital
Wakayama, Japan
Yamagata Sakuracho Hospital
Yamagata, Japan