A Clinical Study to Evaluate the Long-term Safety and Tolerability of an Investigational Drug in People With Schizophrenia
Terminated · Phase 3 · NCT04109950
Conditions: Schizophrenia
At a glance
- Research payments reported, 2025
- $10,130
- U.S. investigators named
- 1
- Sites paid
- 1
- Planned or actual enrollment
- 463
About the trial
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Tested
- SEP-363856 (drug)
- Dates
- Started 2019-11-20; completion 2023-11-09
- Results posted
- Not yet
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.
From ClinicalTrials.gov, last updated 2024-12-16. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sumitomo Pharma America, Inc. reported $10,130 in research payments for this study in 2025 (3 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Advanced Research Center Inc $10,130
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.