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: April 5, 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 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.

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

Following a screening period of up to 21 days, eligible participants will take part in the study. In the 8-week treatment period, participants will be treated with SEP-363856 while continuing to take the full dose of their pre-switch antipsychotic. After the end of the treatment period, participants will be 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

  • 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

  • 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

  • Uptown Research

    Chicago, Illinois 60640
    United States

    Site Not Available

  • CBH Health

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • PsychCare Consultants Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • IMA Clinical Research

    Las Vegas, Nevada 89102
    United States

    Site Not Available

  • Hassman Research Institute

    Berlin, New Jersey 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

  • Charak Clinical Research Center

    Garfield Heights, Ohio 44125
    United States

    Site Not Available

  • Pillar Clinical Research, LLC

    Richardson, Texas 75080
    United States

    Site Not Available

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