NCT05741528CompletedPhase 3
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
An Open-label Extension Study to Assess the 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)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 75 (actual)
- First submitted
- 13 Feb 2023
- Start date
- 31 Mar 2023
- Primary completion date
- 23 Sept 2024
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- Diseases
- Schizophrenia
- NCT number
- NCT05741528
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 75
- From 31 Mar 2023 to the primary completion date, 23 Sept 2024
- 15 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
- Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.
Other
- 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.
- Female subject is pregnant or lactating.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.