NCT06894212

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

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants With Schizophrenia

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 522 (estimated)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

A Phase 3, Randomized, Double-blind, Parallel-group, Placebo-controlled, Multicenter Trial to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Participants with Schizophrenia

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SEP-363856	tablet
OTHER	Placebo	tablet

Timeline

• Start date: 2025-02-28
• Primary completion: 2026-10-20
• Completion: 2026-10-29
• First posted: 2025-03-25
• Last updated: 2026-02-18

Locations

60 sites across 2 countries: United States, Japan

Regulatory

• FDA-regulated drug study