A Clinical Trial to Study the Efficacy and Safety of an Investigational Drug in Acutely Psychotic People With Schizophrenia
Completed · Phase 3 · NCT04072354
Conditions: Schizophrenia
At a glance
- Research payments reported, 2025
- $437,245
- U.S. investigators named
- 3
- Sites paid
- 3
- Planned or actual enrollment
- 463
About the trial
- Sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Tested
- SEP-363856 50mg (drug), SEP-363856 75mg (drug), Placebo (drug)
- Dates
- Started 2019-09-17; completion 2023-09-12
- 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 13 years old -65 years old who have been diagnosed with schizophrenia.
From ClinicalTrials.gov, last updated 2026-05-28. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sumitomo Pharma America, Inc. reported $437,245 in research payments for this study in 2025 (36 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
- Steven Macina, DO Psychiatry · Huntington Beach, CA
- 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 $264,710
- Atlanta Center for Medical Research $159,345
- Advanced Research Center Inc $13,190
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.