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

To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia

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.