NCT04115319

A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.

A Randomized, Double-blind, Active Comparator-Controlled Study to Evaluate the Long-term Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 305 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A clinical study to evaluate the long-term safety and tolerability of an investigational drug in people with schizophrenia. This study is accepting male and female participants between 18 years old -65 years old who have been diagnosed with schizophrenia. This study will be conducted in approximately 50 study centers worldwide. The study will last approximately 57 weeks.

Detailed description

This is a 52-week, multicenter, randomized, double-blind, parallel-group, flexible-dose study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) compared with quetiapine XR (400 to 800 mg/day) in clinically stable adult participants with schizophrenia. This study is projected to randomize a least 300 participants to two treatment groups (SEP-363856 50 to 100 mg/day or quetiapine XR 400 to 800 mg/day) in a 2:1 ratio. Study drug will be taken once a day and may be taken without food or with a light meal. Sumitomo Pharma America Inc. was the former Sponsor and conducted this study. Sumitomo was responsible for analysis and clinical study report (CSR) completion. Otsuka took over study after IND was transferred and is concluding activities with registry postings.

Conditions

• Schizophrenia

Interventions

Type	Name	Description
DRUG	SEP363856	SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule
DRUG	quetiapine XR	quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Timeline

• Start date: 2019-11-21
• Primary completion: 2022-12-30
• Completion: 2022-12-30
• First posted: 2019-10-04
• Last updated: 2025-12-31
• Results posted: 2025-12-31

Locations

42 sites across 4 countries: United States, Romania, Russia, Ukraine

Regulatory

• FDA-regulated drug study