A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
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.
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
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
Interventions
- SEP-363856 50mg Drug
- SEP-363856 75mg Drug
- Placebo Drug
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 16, 2019
- Primary completion
- May 11, 2023
- Completion
- Sep 11, 2023
- Last update posted
- May 27, 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 27, 2026 · Synced Jul 23, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04072354 live on ClinicalTrials.gov.