A Multicenter, Uncontrolled, Open-label Trial to Evaluate the Tolerability, Safety, and Efficacy of Long-term Administration of SEP-363856 in Patients With Schizophrenia
| Registry | NCT07225712 |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional; non randomized, single group, masking: none, treatment |
| Enrollment | 100 (Estimated) |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. (Industry) |
| Conditions | Schizophrenia |
| Interventions | SEP-363856 (Drug) |
| Dates | start 2025-12-22, primary completion 2028-03-01 (estimated), completion 2028-03-01 (estimated), first posted 2025-11-10, last updated 2026-01-14 |
| Locations | 1 site in Japan |
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To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SEP-363856 75 or 100 mg/day (dose selected per protocol) | Experimental | Drug: SEP-363856 | SEP-363856 will be administered at 50 mg/day from Day 1 to Day 3, and 75 mg/day from Day 4 to Day 7. From Day 8 onward, the dose will, in principle, be 100 mg/day unless there are tolerability concerns; however, in accordance with protocol, the investigator or sub-investigator may select either 75 mg/day or 100 mg/day. |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Jimbo Kokorono Clinic | Fukuoka | Japan | Recruiting |