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

Last updated: October 30, 2025
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Overall Status: Completed

Phase

3

Condition

Tourette's Syndrome

Mood Disorders

Schizotypal Personality Disorder (Spd)

Treatment

SEP-363856

Clinical Study ID

NCT05628103
SEP361-308
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: This list is not all inclusive

  • Participants meets Diagnostic and Statistical Manual of Mental Disorders, FifthEdition (DSM-5) criteria for a diagnosis of schizophrenia.

  • Participants are judged to be clinically stable (ie, no evidence of an acuteexacerbation of schizophrenia) by the Investigator for at least 8 weeks prior toBaseline.

  • Participants must be judged by the Investigator to be an appropriate candidate forswitching current antipsychotic medication due to safety or tolerability concernsand/or insufficient efficacy.

  • Participants are taking an oral antipsychotic and the antipsychotic regimen has beenstable for at least 6 weeks prior to Screening.

Exclusion

Exclusion Criteria:This list is not all inclusive

  • Participant has a current DSM-5 diagnosis or presence of symptoms consistent with amajor psychiatric disorder, other than schizophrenia, that is the primary focus oftreatment.

  • Participants are at significant risk of harming self or others based oninvestigator's judgment.

  • Participant has any clinically significant unstable medical condition or anyclinically 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.

Study Design

Total Participants: 101
Treatment Group(s): 1
Primary Treatment: SEP-363856
Phase: 3
Study Start date:
December 19, 2022
Estimated Completion Date:
April 01, 2024

Study Description

This was an 8-week, outpatient, multicenter, open-label, single-group, flexible-dose study.

Following a screening period of up to 21 days, eligible participants took part in the study. In the 8-week treatment period, participants were treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants were required to complete the follow-up visit, 7 days after the last dose of SEP-363856.

Connect with a study center

  • Advanced Research Center, Inc.

    Anaheim, California 92805
    United States

    Site Not Available

  • Clinical Innovations Inc.

    Bellflower, California 90706
    United States

    Site Not Available

  • ProScience Research Group

    Culver City, California 90230
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Garden Grove, California 92845
    United States

    Site Not Available

  • Synergy San Diego

    Lemon Grove, California 91945
    United States

    Site Not Available

  • Clinical Innovations, Inc

    Riverside, California 92506
    United States

    Site Not Available

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

    San Diego, California 92102
    United States

    Site Not Available

  • CMB Clinical Trials

    Santee, California 92071
    United States

    Site Not Available

  • Cenexel CNS Research

    Torrance, California 90502
    United States

    Site Not Available

  • Advanced Research Center, Inc.

    Anaheim 5323810, California 5332921 92805
    United States

    Site Not Available

  • Clinical Innovations Inc.

    Bellflower 5327422, California 5332921 90706
    United States

    Site Not Available

  • ProScience Research Group

    Culver City 5341114, California 5332921 90230
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Garden Grove 5351515, California 5332921 92845
    United States

    Site Not Available

  • Synergy San Diego

    Lemon Grove 5365893, California 5332921 91945
    United States

    Site Not Available

  • Clinical Innovations, Inc

    Riverside 5387877, California 5332921 92506
    United States

    Site Not Available

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

    San Diego 5391811, California 5332921 92102
    United States

    Site Not Available

  • CMB Clinical Trials

    Santee 5393429, California 5332921 92071
    United States

    Site Not Available

  • Cenexel CNS Research

    Torrance 5403022, California 5332921 90502
    United States

    Site Not Available

  • Larkin Behavioral Health Services

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Premier Clinical Research Institute, Inc.

    Miami, Florida 33122
    United States

    Site Not Available

  • Wellness Research Center

    Miami, Florida 33135
    United States

    Site Not Available

  • Behavioral Clinical Research, Inc

    Miami Lakes, Florida 33016
    United States

    Site Not Available

  • Nova Psychiatry, Inc.

    Orlando, Florida 32803
    United States

    Site Not Available

  • Larkin Behavioral Health Services

    Hollywood 4158928, Florida 4155751 33021
    United States

    Site Not Available

  • Premier Clinical Research Institute, Inc.

    Miami 4164138, Florida 4155751 33122
    United States

    Site Not Available

  • Wellness Research Center

    Miami 4164138, Florida 4155751 33135
    United States

    Site Not Available

  • Nova Psychiatry, Inc.

    Orlando 4167147, Florida 4155751 32803
    United States

    Site Not Available

  • Advanced Discovery Research LLC

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Atlanta Behavioral Research

    Atlanta, Georgia 30358
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Advanced Discovery Research LLC

    Atlanta 4180439, Georgia 4197000 30318
    United States

    Site Not Available

  • Atlanta Behavioral Research

    Atlanta 4180439, Georgia 4197000 30358
    United States

    Site Not Available

  • Atlanta Center for Medical Research

    Atlanta 4180439, Georgia 4197000 30331
    United States

    Site Not Available

  • Uptown Research

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Uptown Research

    Chicago 4887398, Illinois 4896861 60640
    United States

    Site Not Available

  • CBH Health

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • CBH Health

    Gaithersburg 4355843, Maryland 4361885 20877
    United States

    Site Not Available

  • PsychCare Consultants Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • PsychCare Consultants Research

    St Louis 4407066, Missouri 4398678 63128
    United States

    Site Not Available

  • IMA Clinical Research

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • IMA Clinical Research

    Las Vegas 5506956, Nevada 5509151 89102
    United States

    Site Not Available

  • Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Hassman Research Institute

    Berlin 4500771, New Jersey 5101760 08009
    United States

    Site Not Available

  • New Hope Clinical Research

    Charlotte, North Carolina 28211
    United States

    Site Not Available

  • Clinical Trials of America, LLC

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • New Hope Clinical Research

    Charlotte 4460243, North Carolina 4482348 28211
    United States

    Site Not Available

  • Clinical Trials of America, LLC

    Hickory 4470778, North Carolina 4482348 28601
    United States

    Site Not Available

  • Charak Clinical Research Center

    Garfield Heights, Ohio 44125
    United States

    Site Not Available

  • Charak Clinical Research Center

    Garfield Heights 5155499, Ohio 5165418 44125
    United States

    Site Not Available

  • Pillar Clinical Research, LLC

    Richardson, Texas 75080
    United States

    Site Not Available

  • Pillar Clinical Research, LLC

    Richardson 4722625, Texas 4736286 75080
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.