NCT07225712 A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia
| NCT ID | NCT07225712 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Otsuka Pharmaceutical Co., Ltd. |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-12-22 |
| Primary Completion | 2028-03 |
Trial Parameters
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Brief Summary
To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia
Eligibility 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 an
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