A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia

ClinicalTrials.gov ID: NCT04072354

Public ClinicalTrials.gov record NCT04072354. 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 26, 2026, 5:21 AM 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, Parallel-group, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of SEP-363856 in Acutely Psychotic Subjects With Schizophrenia

Brief summary

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

A clinical trial to study the efficacy and safety of an investigational drug in acutely psychotic people with schizophrenia. Participants in the study will either receive the drug being studied or a placebo. This study is accepting male and female participants between 13 years old -65 years old who have been diagnosed with schizophrenia.

Study identification

NCT ID: NCT04072354
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.; Industry
Enrollment: 463 participants

Conditions and interventions

Conditions

Schizophrenia

Interventions

Drug

Eligibility (public fields only)

Age range: 13 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: Sep 17, 2019 (Actual)
Primary completion: May 12, 2023 (Actual)
Completion: Sep 12, 2023 (Actual)
Last update posted: May 28, 2026

2019 – 2023

United States locations

U.S. sites: 18
U.S. states: 8
U.S. cities: 16

Facility	City	State	ZIP	Site status
Research Site	Little Rock	Arkansas	72211	—
Research Site	Anaheim	California	92805	—
Research Site	Bellflower	California	90706	—
Research Site	Lemon Grove	California	91945	—
Research Site	Long Beach	California	90807	—
Research Site	Montclair	California	91763	—
Research Site	Pico Rivera	California	90660	—
Research Site	San Diego	California	92103	—
Research Site	Hollywood	Florida	33021	—
Research Site	Hollywood	Florida	33024	—
Research Site	Miami Springs	Florida	33166	—
Research Site	Atlanta	Georgia	30318	—
Research Site	Atlanta	Georgia	30331	—
Research Site	Decatur	Georgia	30030	—
Research Site	Gaithersburg	Maryland	20877	—
Research Site	Flowood	Mississippi	39232	—
Research Site	Dayton	Ohio	45417	—
Research Site	Austin	Texas	78754	—

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 35 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT04072354, 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 May 28, 2026 · Synced Oct 26, 2026

Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04072354 live on ClinicalTrials.gov.

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