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Phase 3 N=101 Treatment

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

Schizophrenia

Enrolled (actual)
101
Serious AEs
4.0%
Results posted
Nov 2025
Primary outcome: Primary: Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons — 7.9 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
SEP-363856 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Primary completion
Apr 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons
7.9
SECONDARY
Percentage of Participants Who Discontinued From the Study Due to Any Reason
17.8

Summary

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.

Eligibility Criteria

Inclusion Criteria: This list is not all inclusive

  • 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.

Exclusion Criteria:This list is not all inclusive

  • 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.
  • Participants are at significant risk of harming self or others based on investigator's judgment.
  • 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.
  • Female participant who is pregnant or lactating.
  • Participant tests positive for drugs of abuse at Screening.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05628103). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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