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

Otsuka

Status and phase: Enrolling; Phase 3

Conditions: Schizophrenia

Treatments: Drug: SEP-363856

Study type: Interventional

Funder types: Industry

Identifiers

NCT07225712

382-102-00050

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

SEP-363856 75 or 100 mg/day (dose selected per protocol)

Experimental group

Description:

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.

Treatment:

Drug: SEP-363856