A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
Public ClinicalTrials.gov record NCT04109950. 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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Official title
An Open-label Extension Study to Assess the Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a clinical trial to determine the long-term safety and tolerability of an investigational drug in people with schizophrenia. Participants in the study will receive the drug being studied. This study is accepting male and female participants between 13 and 65 years old who have been diagnosed with schizophrenia and have completed Study SEP361-301 (NCT04072354) or Study SEP361-302 (NCT04092686). This study will be conducted in approximately 80 study centers worldwide. The treatment duration for this study is one (1) year.
Study identification
- NCT ID
- NCT04109950
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 463 participants
Conditions and interventions
Conditions
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
- Nov 20, 2019 (Actual)
- Primary completion
- Nov 9, 2023 (Actual)
- Completion
- Nov 9, 2023 (Actual)
- Last update posted
- Dec 16, 2024
2019 – 2023
United States locations
- U.S. sites
- 25
- U.S. states
- 12
- U.S. cities
- 22
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | 72211 | — |
| Research Site | Rogers | Arkansas | 72758 | — |
| Research Site | Anaheim | California | 92805 | — |
| Research Site | Culver City | California | 90230 | — |
| Research Site | Lemon Grove | California | 91945 | — |
| Research Site | Long Beach | California | 90806 | — |
| Research Site | Long Beach | California | 90807 | — |
| Research Site | Montclair | California | 91763 | — |
| Research Site | San Diego | California | 92102 | — |
| Research Site | Sherman Oaks | California | 91403 | — |
| Research Site | Miami Springs | Florida | 33166 | — |
| Research Site | Oakland Park | Florida | 33334 | — |
| Research Site | Atlanta | Georgia | 30030 | — |
| Research Site | Atlanta | Georgia | 30318 | — |
| Research Site | Atlanta | Georgia | 30331 | — |
| Research Site | Decatur | Georgia | 30030 | — |
| Research Site | Lake Charles | Louisiana | 70629 | — |
| Research Site | Gaithersburg | Maryland | 20877 | — |
| Research Site | Flowood | Mississippi | 39232 | — |
| Research Site | St Louis | Missouri | 63125 | — |
| Research Site | Marlton | New Jersey | 08053 | — |
| Research Site | New York | New York | 10032 | — |
| Research Site | Dayton | Ohio | 45417 | — |
| Research Site | Austin | Texas | 78754 | — |
| 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 53 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04109950, 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 16, 2024 · Synced Nov 11, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04109950 live on ClinicalTrials.gov.