A Clinical Trial That Will Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Completed · Phase 3 · NCT04092686
Conditions: Schizophrenia
At a glance
- Research payments reported, 2025
- $469,010
- U.S. investigators named
- 2
- Sites paid
- 2
- Planned or actual enrollment
- 464
About the trial
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Tested
- SEP-363856 75mg (drug), SEP-363856 100mg (drug), Placebo (drug)
- Dates
- Started 2019-10-14; completion 2023-06-14
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2026-06-18. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sumitomo Pharma America, Inc. reported $469,010 in research payments for this study in 2025 (12 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
- Saundra A. Maass-robinson, M.D Psychiatry · Atlanta, GA
- Robert A. Riesenberg, MD Psychiatry · Atlanta, GA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Cenexel Iresearch LLC $401,250
- Atlanta Center for Medical Research $67,760
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.