A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Schizophrenia
In brief
Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia
Key facts
- Study ID
- NCT06894212
- Run by
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- People needed
- 522
- Starts
- 2025-02-28
- Expected to finish
- 2026-10-29
- Last updated by the study team
- 2026-07-31
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Goryokai Medical Corporation Hospital — Sapporo, Hokkaido, Japan (enrolling)
- Neyagawa Sanatorium — Neyagawa, Osaka, Japan (enrolling)
- Kuramitsu Hospital — Fukuoka, Fukuoka, Japan (enrolling)
- Obihiro Kosei Hospital — Obihiro, Hokkaido, Japan (enrolling)
- Yokohama Hino Hospital — Yokohama, Kanagawa, Japan (enrolling)
- Kansai Medical University Medical Center — Moriguchi-shi, Osaka, Japan (enrolling)
- Seijinkai Seinan Hospital — Hachinohe-shi, Aomori, Japan (enrolling)
- Fukuoka University Hospital — Fukuoka, Fukuoka, Japan (enrolling)
- Social Medical Corporation Asaka Hospital — Kōriyama, Fukushima, Japan (enrolling)
- Nayoro City General Hospital — Nayoro-shi, Hokkaido, Japan (enrolling)
- Tanzawa Hospital — Hadano-shi, Kanagawa, Japan (enrolling)
- Fujimidai Hospital Site — Hiratsuka-shi, Kanagawa, Japan (enrolling)
- Yuge Hospital — Kumamoto, Kumamoto, Japan (enrolling)
- Miyakonojo Shinsei Hospital — Miyakonojo-shi, Miyazaki, Japan (enrolling)
- Hotei Hospital — Konan-shi, Aichi-ken, Japan (enrolling)
- Seishinkai Okehazama Hospital — Toyoake-shi, Aichi-ken, Japan (enrolling)
- National Hospital Organization Shimofusa Psychiatric Medical Center — Chiba, Chiba, Japan (enrolling)
- National Kohnodai Medical Center — Ichikawa-shi, Chiba, Japan (enrolling)
- National Hospital Organization Kokura Medical Center Site — Kokuraminami-ku, Kitakyushu-shi, Fukuoka, Japan (enrolling)
- Shiranui Hospital — Omuta-shi, Fukuoka, Japan (enrolling)
- Hayakawa Clinic — Kure, Hiroshima, Japan (enrolling)
- NHO Kure Medical Center — Kure-shi, Hiroshima, Japan (enrolling)
- Iwate Medical University Hospital — Shiwa-gun, Iwate, Japan (enrolling)
- Hatano Kousei Hospital — Hadano-shi, Kanagawa, Japan (enrolling)
- National Hospital Organization Hizen Psychiatric Medical Center Site — Kanzaki-gun, Saga-ken, Japan (enrolling)
Full record on ClinicalTrials.gov
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