RecruitingPhase 3NCT07225712

A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia

A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Enrollment

100 participants

Start Date

Dec 22, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia

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

Min Age: 18 Years

Inclusion Criteria5

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 Criteria4

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.