Clinical Trial

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

Name: A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia — clinical trial record (NCT07225712)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting Phase 3

View on ClinicalTrials.gov →

Summary

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

Protocol Amendment History 1 amendment

This ClinicalTrials.gov record has been amended once since 2025-11-05.

Status change: Not Yet Recruiting → Recruiting 2026-01-13

Trial Details

NCT Number	NCT07225712
Lead Sponsor	Otsuka Pharmaceutical Co., Ltd.
Conditions	Schizophrenia
Enrollment	100 participants
Start Date	2025-12-22
Primary Completion	2028-03 (estimated)
Study Completion	2028-03 (estimated)
Updated on ClinicalTrials.gov	2026-01-14