NCT06882785RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT in Acutely Psychotic Japanese Adult Participants With Schizophrenia
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
Source: ClinicalTrials.gov · Last updated 2 Nov 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of KarXT in acutely psychotic Japanese adult participants with schizophrenia
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 250 (estimated)
- First submitted
- 17 Mar 2025
- Start date
- 10 Jun 2025
- Primary completion date
- 23 Sept 2028
- Lead sponsor
- Bristol-Myers Squibb
- Diseases
- Schizophrenia
- NCT number
- NCT06882785
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 250
- From 10 Jun 2025 to the primary completion date, 23 Sept 2028
- 56 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening.
Other illness
- Participants must not have any history or presence of clinically significant medical conditions.
Other
- Participants must not be newly diagnosed or experiencing their first treated episode of schizophrenia.
- Other protocol-defined Inclusion/Exclusion criteria apply.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (56)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Takeda General Hospital - Aizuwakamatsu Coordinator of this site? Confirm its status | Aizu-Wakamatsu | Japan | Recruiting |
| National Hospital Organization Shimofusa Psychiatric Medical Center Coordinator of this site? Confirm its status | Chiba | Japan | Recruiting |
| Kuramitsu Hospital Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| University of the Ryukyus Hospital Coordinator of this site? Confirm its status | Ginowan | Japan | Recruiting |
| Local Institution - 0012 Coordinator of this site? Confirm its status | Hachiōji | Japan | Withdrawn |
| Local Institution - 0025 Coordinator of this site? Confirm its status | Hadano-shi | Japan | Not yet recruiting |
| Osaka Psychiatric Medical Center Coordinator of this site? Confirm its status | Hirakata | Japan | Recruiting |
| Fujimidai Hospital Coordinator of this site? Confirm its status | Hiratsuka | Japan | Recruiting |
| National Kohnodai Medical Center. Coordinator of this site? Confirm its status | Ichikawa | Japan | Recruiting |
| Local Institution - 0032 Coordinator of this site? Confirm its status | Iizuka | Japan | Withdrawn |
| Rainbow and Sea Hospital Coordinator of this site? Confirm its status | Karatsu-shi | Japan | Recruiting |
| Local Institution - 0037 Coordinator of this site? Confirm its status | Kitakyushu | Japan | Not yet recruiting |
| National Center of Neurology and Psychiatry Coordinator of this site? Confirm its status | Kodaira | Japan | Recruiting |
| Local Institution - 0014 Coordinator of this site? Confirm its status | Komoro | Japan | Withdrawn |
| Hotei Hospital Coordinator of this site? Confirm its status | Kōnan | Japan | Recruiting |
| Saitama Konan Hospital Coordinator of this site? Confirm its status | Kumagaya | Japan | Recruiting |
| Yuge Hospital Coordinator of this site? Confirm its status | Kumamoto | Japan | Recruiting |
| Kure Medical Center Coordinator of this site? Confirm its status | Kure | Japan | Recruiting |
| University Hospital Kyoto Prefectural University of Medicine Coordinator of this site? Confirm its status | Kyoto | Japan | Recruiting |
| Asuka Hospital Coordinator of this site? Confirm its status | Machida | Japan | Recruiting |
| National Hospital Organization Maizuru Medical Center Coordinator of this site? Confirm its status | Maizuru | Japan | Recruiting |
| Local Institution - 0050 Coordinator of this site? Confirm its status | Matsumoto | Japan | Withdrawn |
| Miyakonojo Shinsei Hospital Coordinator of this site? Confirm its status | Miyakonojō | Japan | Recruiting |
| Miyazaki Prefectural Miyazaki Hospital Coordinator of this site? Confirm its status | Miyazaki | Japan | Recruiting |
| Kansai Medical University Medical Center Coordinator of this site? Confirm its status | Moriguchi | Japan | Recruiting |
| Nagoya University Hospital Coordinator of this site? Confirm its status | Nagoya | Japan | Recruiting |
| Nagaokai Medical Corporation - Neyagawa Sanatorium Coordinator of this site? Confirm its status | Neyagawa | Japan | Recruiting |
| Okayama University Hospital Coordinator of this site? Confirm its status | Okayama | Japan | Recruiting |
| Local Institution - 0018 Coordinator of this site? Confirm its status | Okinawa | Japan | Not yet recruiting |
| Shiranui Hospital Coordinator of this site? Confirm its status | Omuta | Japan | Recruiting |
| Asakayama Hospital Coordinator of this site? Confirm its status | Osaka | Japan | Recruiting |
| Toho University Omori Medical Center Coordinator of this site? Confirm its status | Ōta-ku | Japan | Recruiting |
| Kitasato University Hospital Coordinator of this site? Confirm its status | Sagamihara | Japan | Recruiting |
| Saitama Neuropsychitric Institute Coordinator of this site? Confirm its status | Saitama | Japan | Recruiting |
| Hokkaido University Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Goryokai Medical Corporation - Goryokai Hospital Coordinator of this site? Confirm its status | Sapporo | Japan | Recruiting |
| Tokyo Metropolitan Matsuzawa Hospital Coordinator of this site? Confirm its status | Setagaya City | Japan | Recruiting |
| Dokkyo Medical University Hospital Coordinator of this site? Confirm its status | Shimotsuga | Japan | Recruiting |
| Local Institution - 0054 Coordinator of this site? Confirm its status | Shimotsuke | Japan | Not yet recruiting |
| Narimasu Kosei Hospital Coordinator of this site? Confirm its status | tabashi City | Japan | Recruiting |
| Osaka Medical and Pharmaceutical University Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Recruiting |
| Shin-Abuyama Hospital Coordinator of this site? Confirm its status | Takatsuki | Japan | Recruiting |
| Holy Cross Hospital - Toki Coordinator of this site? Confirm its status | Toki | Japan | Recruiting |
| Tokushima University Hospital Coordinator of this site? Confirm its status | Tokushima | Japan | Recruiting |
| Inuo Hospital Coordinator of this site? Confirm its status | Tosu | Japan | Recruiting |
| Local Institution - 0033 Coordinator of this site? Confirm its status | Tottori | Japan | Withdrawn |
| Fujita Health University Coordinator of this site? Confirm its status | Toyoake | Japan | Recruiting |
| Okehazama Hospital Coordinator of this site? Confirm its status | Toyoake | Japan | Recruiting |
| Yamaguchi University Hospital Coordinator of this site? Confirm its status | Ube | Japan | Recruiting |
| Tochigi Prefectural Okamotodai Hospital Coordinator of this site? Confirm its status | Utsunomiya | Japan | Recruiting |
| Wakayama Medical University Hospital Coordinator of this site? Confirm its status | Wakayama | Japan | Recruiting |
| Yamagata Sakuracho Hospital Coordinator of this site? Confirm its status | Yamagata | Japan | Recruiting |
| Local Institution - 0019 Coordinator of this site? Confirm its status | Yatsushiro | Japan | Withdrawn |
| Hino Hospital - Yokohama Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Tsurumi Nishii Hospital Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
| Yokohama City University Medical Center Coordinator of this site? Confirm its status | Yokohama | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.