Phase 3
Completed N=101
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
Source: ClinicalTrials.gov NCT05628103 ↗Enrolled (actual)
101
Serious AEs
4.0%
Results posted
Nov 2025
Primary outcomePrimary: Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons — 7.9 percentage of participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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. Informational only — not medical advice.