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RECRUITINGPhase 3INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

To evaluate the safety of SEP-363856 (75 mg/day or 100 mg/day) administered for 52 weeks in adult participants with schizophrenia

Who May Be Eligible (Plain English)

Who May Qualify: - Japanese male or female participants 18 years of age or older at the time of willing to sign a consent form - 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) Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

SEP-363856

Tablet, once daily, for 52 weeks

Locations (1)

Jimbo Kokorono Clinic
Fukuoka, Japan