NCT07225712RecruitingPhase 3
A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia
Source: ClinicalTrials.gov · Last updated 14 Jan 2026
Brief summary (registry, in English)
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- First submitted
- 5 Nov 2025
- Start date
- 22 Dec 2025
- Primary completion date
- 31 Mar 2028
- Lead sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Diseases
- Schizophrenia
- NCT number
- NCT07225712
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 100
- From 22 Dec 2025 to the primary completion date, 31 Mar 2028
- 1 site 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
- History of psychiatric hospitalization within 8 weeks prior to screening
- History of treatment with clozapine
- Unwillingness, before or during the trial period, to comply with the requirements for prior and concomitant medications/therapies as specified in the protocol or use of prohibited medications at screening or baseline as specified in the protocol.
Other illness
- Treatment-resistant to antipsychotic therapy (ie, within 1 year to screening, despite administration of two or more marketed antipsychotics at appropriate doses for at least 4 weeks \[28 consecutive days\] in accordance with the package insert, psychiatric symptoms did not improve)
Who the study is looking for
- Japanese male or female participants 18 years of age or older at the time of informed consent
- Diagnosed with schizophrenia according to the DSM-5®
- Judged by the investigator to be clinically stable for at least 8 weeks prior to screening
- PANSS total score of 80 or less and CGI-S score 4 or less at both screening and baseline
- No changes in antipsychotic medication for at least 6 weeks before screening (excluding minor dose adjustments for tolerability)
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Jimbo Kokorono Clinic Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.