Tests KarXT in Japanese adults with acute psychosis from schizophrenia
Tests KarXT against placebo in Japanese adults with acute schizophrenia psychosis.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
Key facts
- Where
- Aizu-Wakamatsu, Chiba, Fukuoka, Ginowan, Hachiōji, Hadano-shi, Hirakata, Hiratsuka, Ichikawa, Iizuka, Karatsu-shi, Kitakyushu, Kodaira, Komoro, Kōnan, Kumagaya, Kumamoto, Kure, Kyoto, Machida, Maizuru, Matsumoto, Miyakonojō, Miyazaki, Moriguchi, Nagoya, Neyagawa, Okayama, Okinawa, Omuta, Osaka, Ōta-ku, Sagamihara, Saitama, Sapporo, Setagaya City, Shimotsuga, Shimotsuke, tabashi City, Takatsuki, Toki, Tokushima, Tosu, Tottori, Toyoake, Ube, Utsunomiya, Wakayama, Yamagata, Yatsushiro, and Yokohama, JapanSee the 56 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06882785, who can take part
Where in Japan
- Takeda General Hospital - AizuwakamatsuAizu-Wakamatsu, JapanTaking people
- National Hospital Organization Shimofusa Psychiatric Medical CenterChiba, JapanTaking people
- Kuramitsu HospitalFukuoka, JapanTaking people
- University of the Ryukyus HospitalGinowan, JapanTaking people
- HachiōjiHachiōji, JapanNo longer taking part
- Hadano-shiHadano-shi, JapanNot yet recruiting
- Osaka Psychiatric Medical CenterHirakata, JapanTaking people
- Fujimidai HospitalHiratsuka, JapanTaking people
- National Kohnodai Medical Center.Ichikawa, JapanTaking people
- IizukaIizuka, JapanNo longer taking part
- Rainbow and Sea HospitalKaratsu-shi, JapanTaking people
- KitakyushuKitakyushu, JapanNot yet recruiting
- National Center of Neurology and PsychiatryKodaira, JapanTaking people
- KomoroKomoro, JapanNo longer taking part
- Hotei HospitalKōnan, JapanTaking people
- Saitama Konan HospitalKumagaya, JapanTaking people
- Yuge HospitalKumamoto, JapanTaking people
- Kure Medical CenterKure, JapanTaking people
- University Hospital Kyoto Prefectural University of MedicineKyoto, JapanTaking people
- Asuka HospitalMachida, JapanTaking people
- National Hospital Organization Maizuru Medical CenterMaizuru, JapanTaking people
- MatsumotoMatsumoto, JapanNo longer taking part
- Miyakonojo Shinsei HospitalMiyakonojō, JapanTaking people
- Miyazaki Prefectural Miyazaki HospitalMiyazaki, JapanTaking people
- Kansai Medical University Medical CenterMoriguchi, JapanTaking people
- Nagoya University HospitalNagoya, JapanTaking people
- Nagaokai Medical Corporation - Neyagawa SanatoriumNeyagawa, JapanTaking people
- Okayama University HospitalOkayama, JapanTaking people
- OkinawaOkinawa, JapanNot yet recruiting
- Shiranui HospitalOmuta, JapanTaking people
- Asakayama HospitalOsaka, JapanTaking people
- Toho University Omori Medical CenterŌta-ku, JapanTaking people
- Kitasato University HospitalSagamihara, JapanTaking people
- Saitama Neuropsychitric InstituteSaitama, JapanTaking people
- Goryokai Medical Corporation - Goryokai HospitalSapporo, JapanTaking people
- Hokkaido University HospitalSapporo, JapanTaking people
- Tokyo Metropolitan Matsuzawa HospitalSetagaya City, JapanTaking people
- Dokkyo Medical University HospitalShimotsuga, JapanTaking people
- ShimotsukeShimotsuke, JapanNot yet recruiting
- Narimasu Kosei Hospitaltabashi City, JapanTaking people
- Osaka Medical and Pharmaceutical University HospitalTakatsuki, JapanTaking people
- Shin-Abuyama HospitalTakatsuki, JapanTaking people
- Holy Cross Hospital - TokiToki, JapanTaking people
- Tokushima University HospitalTokushima, JapanTaking people
- Inuo HospitalTosu, JapanTaking people
- TottoriTottori, JapanNo longer taking part
- Fujita Health UniversityToyoake, JapanTaking people
- Okehazama HospitalToyoake, JapanTaking people
- Yamaguchi University HospitalUbe, JapanTaking people
- Tochigi Prefectural Okamotodai HospitalUtsunomiya, JapanTaking people
- Wakayama Medical University HospitalWakayama, JapanTaking people
- Yamagata Sakuracho HospitalYamagata, JapanTaking people
- YatsushiroYatsushiro, JapanNo longer taking part
- Hino Hospital - YokohamaYokohama, JapanTaking people
- Tsurumi Nishii HospitalYokohama, JapanTaking people
- Yokohama City University Medical CenterYokohama, JapanTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT06882785
- Record updated
- 2 November 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophreniaRead full original descriptionShow less
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
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
Inclusion: 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: Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening; Participants must not have any history or presence of clinically significant medical conditions; Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia; Other protocol-defined Inclusion/Exclusion criteria apply.