NCT05628103CompletedPhase 3
A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication
An 8-Week, Open-Label Study Evaluating the Effectiveness, Safety and Tolerability of SEP-363856 in Subjects With Schizophrenia Switched From Typical or Atypical Antipsychotic Agents
Source: ClinicalTrials.gov · Last updated 11 Dec 2025
Brief summary (registry, in English)
This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 101 (actual)
- First submitted
- 16 Nov 2022
- Start date
- 19 Dec 2022
- Primary completion date
- 1 Apr 2024
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Diseases
- Schizophrenia
- NCT number
- NCT05628103
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 101
- From 19 Dec 2022 to the primary completion date, 1 Apr 2024
- 25 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participant tests positive for drugs of abuse at Screening.
Other illness
- Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
- Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study.
Other
- Participants are at significant risk of harming self or others based on investigator's judgment.
- Female participant who is pregnant or lactating.
Who the study is looking for
- Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
- Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
- Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
- Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (25)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Advanced Research Center, Inc. Coordinator of this site? Confirm its status | Anaheim | United States | Unknown status |
| Advanced Discovery Research, Llc Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Atlanta Behavioral Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Atlanta Center for Medical Research Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Clinical Innovations, Inc. Coordinator of this site? Confirm its status | Bellflower | United States | Unknown status |
| Hassman Research Institute Coordinator of this site? Confirm its status | Berlin | United States | Unknown status |
| New Hope Clinical Research Coordinator of this site? Confirm its status | Charlotte | United States | Unknown status |
| Uptown Research Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| ProScience Research Group Coordinator of this site? Confirm its status | Culver City | United States | Unknown status |
| CBH Health Coordinator of this site? Confirm its status | Gaithersburg | United States | Unknown status |
| Collaborative NeuroScience Research , LLC Coordinator of this site? Confirm its status | Garden Grove | United States | Unknown status |
| Charak Clinical Research Center Coordinator of this site? Confirm its status | Garfield Heights | United States | Unknown status |
| Clinical Trials of America, LLC Coordinator of this site? Confirm its status | Hickory | United States | Unknown status |
| Larkin Behavioral Health Services Coordinator of this site? Confirm its status | Hollywood | United States | Unknown status |
| IMA Clinical Research Coordinator of this site? Confirm its status | Las Vegas | United States | Unknown status |
| Synergy San Diego Coordinator of this site? Confirm its status | Lemon Grove | United States | Unknown status |
| Wellness Research Center Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Premier Clinical Research Institute Inc Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Nova Psychiatry Inc. Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Pillar Clinical Research, LLC Coordinator of this site? Confirm its status | Richardson | United States | Unknown status |
| Clinical Innovations, Inc. Coordinator of this site? Confirm its status | Riverside | United States | Unknown status |
| California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC) Coordinator of this site? Confirm its status | San Diego | United States | Unknown status |
| CMB Clinical Trials Coordinator of this site? Confirm its status | Santee | United States | Unknown status |
| PsychCare Consultants Research Coordinator of this site? Confirm its status | St Louis | United States | Unknown status |
| Cenexel CNS Research Coordinator of this site? Confirm its status | Torrance | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.