A Long-term Administration Trial of SEP-363856 in Patient... | NCT07225712

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

NCT07225712

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Status

Recruiting

Last Update Posted

Jan 14, 2026Actual

Enrollment

100Estimated

Phase

Phase 3

Conditions

Schizophrenia

Interventions

SEP-363856

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 22, 2025Actual

Primary Completion Date

Mar 2028Estimated

Completion Date

Mar 2028Estimated

First Submitted Date

Nov 5, 2025

First Submission Date that Met QC Criteria

Nov 5, 2025

First Posted Date

Nov 10, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 13, 2026

Last Update Posted Date

Jan 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SEP-363856	Drug	Tablet, once daily, for 52 weeks	SEP-363856 75 or 100 mg/day (dose selected per protocol)

Measure	Description	Time Frame
・Incidence of treatment-emergent adverse events (TEAEs)		52 weeks

Eligibility Module

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 and concomitant medications/therapies as specified in the protocol or use of prohibited medications at screening or baseline as specified in the protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Drug Information Center	Contact	+81-3-6361-7314

Name	Affiliation	Role
Nobuhito Sanada	Otsuka Pharmaceutical Co., Ltd.	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Jimbo Kokorono Clinic	Recruiting	Fukuoka			Japan

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

Types

Study Protocol
Statistical Analysis Plan (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.

URL

Not provided

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders