A Long-term Administration Trial of SEP-363856 in Patients With Schizophrenia

Not Applicable

Not yet recruiting

• Conditions: Schizophrenia
• Interventions: Drug: SEP-363856

• Registration Number: NCT07225712
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-11
• Study First Submitted: 2025-11-05
• Study First Submitted QC: 2025-11-05
• Last Update Submitted: 2025-11-05
• Study First Posted: 2025-11-10
• Last Update Posted: 2025-11-10
• Study Start: 2025-12-01
• Primary Completion: 2028-03
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SEP-363856 75 or 100 mg/day (dose selected per protocol)	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.

Primary Outcome Measures

Name	Time	Method
・Incidence of treatment-emergent adverse events (TEAEs)	52 weeks

Trial Locations

Locations (1)

Jimbo Kokorono Clinic; 🇯🇵 Fukuoka, Japan