A Clinical Study That Will Evaluate How Well SEP-363856 Works and How Safe it is in People With Schizophrenia That Switch to SEP-363856 From Their Current Antipsychotic Medication

NCT05628103 | Completed Phase 3 Results FDA Drug

• 1 other identifier: SEP361-308
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 25

Brief Summary

This study evaluated how well SEP-363856 works and how safe it is in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication.

Conditions

Schizophrenia

Keywords

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Discontinued From the Study Due to Clinical Reasons

  Discontinuation for clinical reasons was defined as reasons due to adverse event (AE) or lack of efficacy. AEs are defined as untoward medical occurrences that started at the same time of or after the first dose of study drug. The percentage of participants who discontinued for clinical reasons was calculated by a proportion consisting of the number of participants who experience a discontinuation event due to clinical reasons as the numerator divided by the number of participants in the safety population as the denominator multiplied by 100 along with a corresponding 95% confidence interval (CI). 95% CI was calculated using the normal approximation method.

  From the first dose of the study drug up to end of follow up (up to Week 9)

Secondary Outcomes (1)

• Percentage of Participants Who Discontinued From the Study Due to Any Reason

  From first dose of the study drug up to end of follow-up period (up to Week 9)

Study Arms (1)

SEP-363856

EXPERIMENTAL

Participants received flexible doses of SEP-363856 50 to 100 milligrams per day (mg/day), orally, once daily (QD) up to Week 8. The dose was titrated up from 50 mg/day on Days 1 to 3, to 75 mg/day on Days 4 to 7. Beginning Day 8, the dose was adjusted within the range of 50 mg/day to 100 mg/day in 25 mg increments (i.e. 50, 75, or 100 mg/day) up to Week 8.

Drug: SEP-363856

Interventions

SEP-363856 DRUG

SEP-363856 flexibly dosed for 8 weeks.

SEP-363856

Eligibility Criteria

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

You may qualify if:

• Participants meets Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for a diagnosis of schizophrenia.
• Participants are judged to be clinically stable (ie, no evidence of an acute exacerbation of schizophrenia) by the Investigator for at least 8 weeks prior to Baseline.
• Participants must be judged by the Investigator to be an appropriate candidate for switching current antipsychotic medication due to safety or tolerability concerns and/or insufficient efficacy.
• Participants are taking an oral antipsychotic and the antipsychotic regimen has been stable for at least 6 weeks prior to Screening.

You may not qualify if:

• Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a major psychiatric disorder, other than schizophrenia, that is the primary focus of treatment.
• Participants are at significant risk of harming self or others based on investigator's judgment.
• Participant has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the participant's ability to complete and/or participate in the study.
• Female participant who is pregnant or lactating.
• Participant tests positive for drugs of abuse at Screening.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (25)

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

Clinical Innovations Inc.

Bellflower, California, 90706, United States

Location

ProScience Research Group

Culver City, California, 90230, United States

Location

Collaborative Neuroscience Research, LLC

Garden Grove, California, 92845, United States

Location

Synergy San Diego

Lemon Grove, California, 91945, United States

Location

Clinical Innovations, Inc

Riverside, California, 92506, United States

Location

California Neuropsychopharmacology Clinical Research Institute, LLC (CNRI-San Diego, LLC)

San Diego, California, 92102, United States

Location

CMB Clinical Trials

Santee, California, 92071, United States

Location

Cenexel CNS Research

Torrance, California, 90502, United States

Location

Larkin Behavioral Health Services

Hollywood, Florida, 33021, United States

Location

Premier Clinical Research Institute, Inc.

Miami, Florida, 33122, United States

Location

Wellness Research Center

Miami, Florida, 33135, United States

Location

Nova Psychiatry, Inc.

Orlando, Florida, 32803, United States

Location

Advanced Discovery Research LLC

Atlanta, Georgia, 30318, United States

Location

Atlanta Center for Medical Research

Atlanta, Georgia, 30331, United States

Location

Atlanta Behavioral Research

Atlanta, Georgia, 30358, United States

Location

Uptown Research

Chicago, Illinois, 60640, United States

Location

CBH Health

Gaithersburg, Maryland, 20877, United States

Location

PsychCare Consultants Research

St Louis, Missouri, 63128, United States

Location

IMA Clinical Research

Las Vegas, Nevada, 89102, United States

Location

Hassman Research Institute

Berlin, New Jersey, 08009, United States

Location

New Hope Clinical Research

Charlotte, North Carolina, 28211, United States

Location

Clinical Trials of America, LLC

Hickory, North Carolina, 28601, United States

Location

Charak Clinical Research Center

Garfield Heights, Ohio, 44125, United States

Location

Pillar Clinical Research, LLC

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

SEP-363856

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Transparency
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

smb_clinicaltranspa@otsuka-us.com

1-800-441-6763

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: November 16, 2022
• First Posted: November 28, 2022
• Study Start: December 19, 2022
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: December 11, 2025
• Results First Posted: November 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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 the Vivli data sharing platform which can be found here: https://vivli.org/ourmember/Otsuka/

Locations

US (25)