Clinical Trial

A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

Name: A Trial of the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia — clinical trial record (NCT06894212)
Creator: DataLookout
License: https://creativecommons.org/licenses/by/4.0/

Recruiting Phase 3

View on ClinicalTrials.gov →

Summary

Evaluate the efficacy and safety of Ulotaront (SEP-363856) in acutely psychotic subjects with schizophrenia

Protocol Amendment History 1 change

notable Trial sites expanded: 60 -> 73 locations 2026-04-24

Trial Details

NCT Number	NCT06894212
Lead Sponsor	Otsuka Pharmaceutical Development & Commercialization, Inc.
Conditions	Schizophrenia
Enrollment	522 participants
Start Date	2025-02-28
Primary Completion	2026-10-20 (estimated)
Study Completion	2026-10-29 (estimated)
Updated on ClinicalTrials.gov	2026-07-31