A Study of the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia.
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.
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
- Enrollment
- 305 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
- Nov 20, 2019
- Primary completion
- Dec 29, 2022
- Completion
- Dec 29, 2022
- Last update posted
- Dec 30, 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 30, 2025 · Synced Sep 2, 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 NCT04115319 live on ClinicalTrials.gov.