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

NCT07225712 | Recruiting Phase 3 FDA Drug

• 1 other identifier: 382-102-00050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• ・Incidence of treatment-emergent adverse events (TEAEs)

  52 weeks

Study Arms (1)

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

EXPERIMENTAL

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.

Drug: SEP-363856

Interventions

SEP-363856 DRUG

Tablet, once daily, for 52 weeks

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Jimbo Kokorono Clinic

Fukuoka, Japan

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Nobuhito Sanada

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Drug Information Center

CONTACT

+81-3-6361-7314

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2025
• First Posted: November 10, 2025
• Study Start: December 22, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

Locations

JP (1)