Phase 3
Completed N=75
An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication
Source: ClinicalTrials.gov NCT05741528 ↗Enrolled (actual)
75
Serious AEs
5.3%
Results posted
Nov 2025
Primary outcomePrimary: Number of Participants With Adverse Events (AEs) — 28 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 This can indicate results are unpublished — a known publication-bias signal.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
An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events (AEs) |
28 | — |
| PRIMARY Number of Participants With Serious Adverse Events |
4 | — |
| PRIMARY Number of Participants With AEs Leading to Discontinuation of Study |
1 | — |
Eligibility Criteria
Inclusion Criteria: (list is not all inclusive)
- Subject has given written informed consent and privacy authorization prior to participation in the study.
- Subject has completed the Treatment Period of Study SEP361-308.
- Subject has not taken any psychotropic medication other than the study drug, pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308.
- Female subject must have a negative rapid urine pregnancy test at the End of Treatment (EOT) Visit of Study SEP361-308.
Exclusion Criteria: (list is not all inclusive)
- Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS) assessment at the End of Treatment (EOT) Visit of Study SEP361-308.
- Subject has a clinically significant abnormality including physical examination, vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308.
- Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.
- Female subject is pregnant or lactating.
Data sourced from ClinicalTrials.gov (NCT05741528). 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.