NCT05741528

An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication

An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.

Detailed description

This is a 24-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed Study SEP361-308 treatment period, during which they were switched from a previous antipsychotic treatment to SEP-363856.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SEP-363856	SEP-363856 tablet

Timeline

• Start date: 2023-03-31
• Primary completion: 2024-09-23
• Completion: 2024-09-23
• First posted: 2023-02-23
• Last updated: 2025-12-11
• Results posted: 2025-11-12

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated drug study