Clinical Trials in Japan / NCT07225712
Recruiting
Phase 3
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
NCT07225712 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Schizophrenia
Study summary
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Eligibility
Inclusion Criteria:
* Japanese male or female participants 18 years of age or older at the time of informed consent
* Diagnosed with schizophrenia according to the DSM-5®
* Judged by the investigator to be clinically stable for at least 8 weeks prior to screening
* PANSS total score of 80 or less and CGI-S score 4 or less at both screening and baseline
* No changes in antipsychotic medication for at least 6 weeks before screening (excluding minor dose adjustments for tolerability)
Exclusion Criteria:
* History of psychiatric hospitalization within 8 weeks prior to screening
* Treatment-resistant to antipsychotic therapy (ie, within 1 year to screening, despite administration of two or more marketed antipsychotics at appropriate doses for at least 4 weeks \[28 consecutive days\] in accordance with the package insert, psychiatric symptoms did not improve)
* History of treatment with clozapine
* Unwillingness, before or during the trial period, to comply with the requirements for prior and concomitant medications/therapies as specified in the protocol or use of prohibited medications at screening or baseline as specified in the protocol.
Primary outcome measure(s)
- ・Incidence of treatment-emergent adverse events (TEAEs) — 52 weeks
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Jimbo Kokorono Clinic | Fukuoka | Japan | Recruiting |
More Otsuka Pharmaceutical Co., Ltd. trials in Japan
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07225712 on ClinicalTrials.gov ↗ ← All trials in Japan