A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Public ClinicalTrials.gov record NCT04092686. 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
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 18 -65 years old who have been diagnosed with schizophrenia. This study will be conducted in 60 locations world wide. The study will last up to nine (9) weeks.
Study identification
- NCT ID
- NCT04092686
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 464 participants
Conditions and interventions
Conditions
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
- Oct 14, 2019 (Actual)
- Primary completion
- Jun 14, 2023 (Actual)
- Completion
- Jun 14, 2023 (Actual)
- Last update posted
- Jun 18, 2026
2019 – 2023
United States locations
- U.S. sites
- 18
- U.S. states
- 11
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Rogers | Arkansas | 72758 | — |
| Research Site | Anaheim | California | 92805 | — |
| Research Site | Bellflower | California | 90706 | — |
| Research Site | Culver City | California | 90230 | — |
| Research Site | Long Beach | California | 90806 | — |
| Research Site | San Diego | California | 92102 | — |
| Research Site | Sherman Oaks | California | 91403 | — |
| Research Site | Hollywood | Florida | 33021 | — |
| Research Site | Miami Springs | Florida | 33166 | — |
| Research Site | Atlanta | Georgia | 30331 | — |
| Research Site | Decatur | Georgia | 30030 | — |
| Research Site | Chicago | Illinois | 60641 | — |
| Research Site | Lake Charles | Louisiana | 70629 | — |
| Research Site | Gaithersburg | Maryland | 20877 | — |
| Research Site | St Louis | Missouri | 63125 | — |
| Research Site | Marlton | New Jersey | 08053 | — |
| Research Site | New York | New York | 10032 | — |
| Research Site | Richardson | Texas | 75080 | — |
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 NCT04092686, 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 Jun 18, 2026 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04092686 live on ClinicalTrials.gov.