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

ClinicalTrials.gov ID: NCT04115319

Public ClinicalTrials.gov record NCT04115319. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Oct 17, 2026, 4:29 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT04115319
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 305 participants

Conditions and interventions

Conditions

Schizophrenia

Interventions

SEP363856 Drug
quetiapine XR Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Nov 21, 2019 (Actual)
Primary completion: Dec 30, 2022 (Actual)
Completion: Dec 30, 2022 (Actual)
Last update posted: Dec 31, 2025

2019 – 2022

United States locations

U.S. sites: 18
U.S. states: 10
U.S. cities: 18

Facility	City	State	ZIP	Site status
Research Site	Cerritos	California	90703	—
Research Site	Oakland	California	94607	—
Research Site	Oceanside	California	92056	—
Research Site	San Diego	California	92103	—
Research Site	Torrance	California	90502	—
Research Site	Miami	Florida	33122	—
Research Site	Miami Lakes	Florida	33016	—
Research Site	Atlanta	Georgia	30328	—
Research Site	Hoffman Estates	Illinois	60169	—
Research Site	Lincolnwood	Illinois	60712	—
Research Site	Shreveport	Louisiana	71101	—
Research Site	St Louis	Missouri	63128	—
Research Site	Las Vegas	Nevada	89102	—
Research Site	Cedarhurst	New York	11516	—
Research Site	Jamaica	New York	11432	—
Research Site	Rochester	New York	14618	—
Research Site	Charlotte	North Carolina	28211	—
Research Site	North Canton	Ohio	44720	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 24 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04115319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Dec 31, 2025 · Synced Oct 17, 2026

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The complete public registry record, listed eligibility criteria, and available contact information for NCT04115319 live on ClinicalTrials.gov.

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