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

Phase 3

Completed

• Conditions: Schizophrenia
• Interventions: Drug: SEP363856; Drug: quetiapine XR

• Registration Number: NCT04115319
• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Brief 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 subjects with schizophrenia. This study is projected to randomize a least 300 subjects 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.

Study Timeline

• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-02
• Study First Posted: 2019-10-04
• Study Start: 2019-11-15
• Primary Completion: 2022-12-30
• Study Completion: 2022-12-30
• Disposition First Submitted: 2023-12-13
• Disposition First Posted: 2023-12-18
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 475

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SEP363856	SEP363856	SEP363856 50mg, 75mg, 100mg, flexibly dosed once daily capsule
quetiapine XR	quetiapine XR	quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule

Primary Outcome Measures

Name	Time	Method
The incidence of overall Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Events (AEs) leading to discontinuation	52 Weeks

Trial Locations

Locations (46)

Synexus Clinical Research US, Inc.; 🇺🇸 Cerritos, California, United States

Pacific Research Partners; 🇺🇸 Oakland, California, United States

Excell Research; 🇺🇸 Oceanside, California, United States

Artemis Institute for Clinical Research; 🇺🇸 San Diego, California, United States

Collaborative Neuroscience Network; 🇺🇸 Torrance, California, United States

Innovative Clinical Research; 🇺🇸 Miami Lakes, Florida, United States

Premier Clinical Research Institute; 🇺🇸 Miami, Florida, United States

Synexus Clinical Research US; 🇺🇸 Atlanta, Georgia, United States

Alexian Brothers Center for Psychiatric Research; 🇺🇸 Hoffman Estates, Illinois, United States

Pillar Clinical Research; 🇺🇸 Lincolnwood, Illinois, United States

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