Long-term SEP-363856 treatment for adults 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
This trial will test whether taking SEP-363856 (75 mg or 100 mg daily) for 52 weeks is safe for adults in Japan who have stable schizophrenia.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. Industry-sponsored |
| Locations | 1 site (Fukuoka) |
| Trial ID | NCT07225712 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional trial gives adult participants with DSM-5 schizophrenia daily SEP-363856 at either 75 mg or 100 mg for 52 weeks to collect long-term safety data. Eligible participants must be clinically stable for at least 8 weeks, have PANSS total ≤80 and CGI-S ≤4, and have had no recent significant antipsychotic changes. The study excludes those with recent psychiatric hospitalization, treatment-resistant illness, or prior clozapine treatment. Safety measures and clinical status will be monitored regularly at the single participating clinic in Fukuoka.
Who should consider this trial
Good fit: Japanese adults aged 18 or older with DSM-5 schizophrenia who have been clinically stable for ≥8 weeks, with PANSS ≤80 and CGI-S ≤4 and no recent antipsychotic changes are the intended participants.
Not a fit: Patients with recent psychiatric hospitalization, treatment-resistant schizophrenia, prior clozapine use, or unstable symptoms are unlikely to benefit from or qualify for this protocol.
Why it matters
Potential benefit: If successful, the drug could become a well-tolerated oral option for long-term maintenance treatment in schizophrenia.
How similar studies have performed: Earlier short-term trials of SEP-363856 showed promising efficacy and tolerability signals, but long-term safety data remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * History of psychiatric hospitalization within 8 weeks prior to screening * 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) * 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.
Where this trial is running
Fukuoka
- Jimbo Kokorono Clinic — Fukuoka, Japan (Recruiting)
Study contacts
- Study coordinator: Drug Information Center
- Phone: +81-3-6361-7314
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.