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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.
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

Full criteria on ClinicalTrials.gov

Sites (25)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Advanced Research Center, Inc.
Coordinator of this site? Confirm its status
AnaheimUnited StatesUnknown status
Advanced Discovery Research, Llc
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Atlanta Behavioral Research
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Atlanta Center for Medical Research
Coordinator of this site? Confirm its status
AtlantaUnited StatesUnknown status
Clinical Innovations, Inc.
Coordinator of this site? Confirm its status
BellflowerUnited StatesUnknown status
Hassman Research Institute
Coordinator of this site? Confirm its status
BerlinUnited StatesUnknown status
New Hope Clinical Research
Coordinator of this site? Confirm its status
CharlotteUnited StatesUnknown status
Uptown Research
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ChicagoUnited StatesUnknown status
ProScience Research Group
Coordinator of this site? Confirm its status
Culver CityUnited StatesUnknown status
CBH Health
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GaithersburgUnited StatesUnknown status
Collaborative NeuroScience Research , LLC
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Garden GroveUnited StatesUnknown status
Charak Clinical Research Center
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Garfield HeightsUnited StatesUnknown status
Clinical Trials of America, LLC
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HickoryUnited StatesUnknown status
Larkin Behavioral Health Services
Coordinator of this site? Confirm its status
HollywoodUnited StatesUnknown status
IMA Clinical Research
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Las VegasUnited StatesUnknown status
Synergy San Diego
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Lemon GroveUnited StatesUnknown status
Wellness Research Center
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MiamiUnited StatesUnknown status
Premier Clinical Research Institute Inc
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MiamiUnited StatesUnknown status
Nova Psychiatry Inc.
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OrlandoUnited StatesUnknown status
Pillar Clinical Research, LLC
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RichardsonUnited StatesUnknown status
Clinical Innovations, Inc.
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RiversideUnited StatesUnknown status
California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)
Coordinator of this site? Confirm its status
San DiegoUnited StatesUnknown status
CMB Clinical Trials
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SanteeUnited StatesUnknown status
PsychCare Consultants Research
Coordinator of this site? Confirm its status
St LouisUnited StatesUnknown status
Cenexel CNS Research
Coordinator of this site? Confirm its status
TorranceUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.