A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Schizophrenia
In brief
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
Key facts
- Study ID
- NCT06882785
- Run by
- Bristol-Myers Squibb
- People needed
- 250
- Starts
- 2025-06-10
- Expected to finish
- 2029-08-23
- Last updated by the study team
- 2026-07-27
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
- Osaka Psychiatric Medical Center — Hirakata, Osaka, Japan (enrolling)
- Shin-Abuyama Hospital — Takatsuki, Osaka, Japan (enrolling)
- Hotei Hospital — Kōnan, Aichi-ken, Japan (enrolling)
- University of the Ryukyus Hospital — Ginowan, Okinawa, Japan (enrolling)
- Kansai Medical University Medical Center — Moriguchi, Osaka, Japan (enrolling)
- Nagaokai Medical Corporation - Neyagawa Sanatorium — Neyagawa, Osaka, Japan (enrolling)
- Fujita Health University — Toyoake, Aichi-ken, Japan (enrolling)
- Shiranui Hospital — Omuta, Fukuoka, Japan (enrolling)
- Takeda General Hospital - Aizuwakamatsu — Aizu-Wakamatsu, Fukushima, Japan (enrolling)
- National Kohnodai Medical Center. — Ichikawa, Chiba, Japan (enrolling)
- National Hospital Organization Shimofusa Psychiatric Medical Center — MIdori-ku, Chiba-shi, Chiba, Japan (enrolling)
- Goryokai Medical Corporation - Goryokai Hospital — Sapporo, Hokkaido, Japan (enrolling)
- Hokkaido University Hospital — Sapporo, Hokkaido, Japan (enrolling)
- Okehazama Hospital — Toyoake, Aichi-ken, Japan (enrolling)
- Fujimidai Hospital — Hiratsuka, Kanagawa, Japan (enrolling)
- Kitasato University Hospital — Sagamihara, Kanagawa, Japan (enrolling)
- Tsurumi Nishii Hospital — Yokohama, Kanagawa, Japan (enrolling)
- Yokohama City University Medical Center — Yokohama, Kanagawa, Japan (enrolling)
- Hino Hospital - Yokohama — Yokohama, Kanagawa, Japan (enrolling)
- Yuge Hospital — Kumamoto, Kumamoto, Japan (enrolling)
- Holy Cross Hospital - Toki — Toki, Gifu, Japan (enrolling)
- National Hospital Organization Maizuru Medical Center — Maizuru, Kyoto, Japan (enrolling)
- Miyakonojo Shinsei Hospital — Miyakonojō, Miyazaki, Japan (enrolling)
- Kure Medical Center — Kure, Hiroshima, Japan (enrolling)
- Osaka Medical and Pharmaceutical University Hospital — Takatsuki, Osaka, Japan (enrolling)
Full record on ClinicalTrials.gov
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