A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Recruiting · NCT06882785 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
KarXTPlacebo
What this trial is about
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
- Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.
- Participants must not have any history or presence of clinically significant medical conditions.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Where it is running
56 locations listed.
- Kuramitsu Hospital - Fukuoka, Japan
- University Hospital,Kyoto Prefectural University of Medicine - Kyoto, Japan
- Miyazaki Prefectural Miyazaki Hospital - Miyazaki, Japan
- Okayama University Hospital - Okayama, Japan
- Local Institution - 0018 - Okinawa, Japan
- Local Institution - 0031 - Osaka, Japan
- Saitama Neuropsychitric Institute - Saitama, Japan
- Tokushima University Hospital - Tokushima, Japan
- Local Institution - 0033 - Tottori, Japan
- Wakayama Medical University Hospital - Wakayama, Japan
- Yamagata Sakuracho Hospital - Yamagata, Japan
- 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
- Holy Cross Hospital - Toki - 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 - 0054 - Shimotsuke, Tochigi, Japan
- Tochigi Prefectural Okamotodai Hospital - Utsunomiya, Tochigi, Japan
- Local Institution - 0012 - Hachiōji, Tokyo, Japan
- National Center of Neurology and Psychiatry - Kodaira, Tokyo, Japan
- Asuka Hospital - Machida, Tokyo, Japan
- Tokyo Metropolitan Matsuzawa Hospital - Setagaya City, Tokyo, Japan
- Narimasu Kosei Hospital - tabashi City, Tokyo, Japan
- Toho University Omori Medical Center - Ōta-ku, Tokyo, Japan
- Yamaguchi University Hospital - Ube, Yamaguchi, Japan