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Recruiting Phase 3

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

NCT07225712 · tracked via the Priya Life Science Japan tracker
Phase
Phase 3
Started
2025-12-22
Last updated
2026-01-14

Condition(s) studied

Schizophrenia

Investigational drug(s) / intervention(s)

SEP-363856 →

SEP-363856: Tablet, once daily, for 52 weeks

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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)

FacilityCityRegionStatus
Jimbo Kokorono Clinic Fukuoka Japan Recruiting
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