An Extension Study to a Clinical Study That Will Continue to Evaluate the Effectiveness and Safety of SEP-363856 in People With Schizophrenia That Switch to SEP-363856 From Their From Their Current Antipsychotic Medication

Last updated: October 31, 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

NCT05741528
SEP361-309
  • Ages 18-65
  • All Genders

Study Summary

An Extension study to a clinical study that will continue to evaluate the effectiveness and safety of SEP-363856 in people with schizophrenia that switch to SEP-363856 from their current antipsychotic medication. This study will accept both male and female participants that have completed study SEP361-308. This study will be held in approximately 24 study sites in North America. Participation in the study will be approximately up to 25 weeks.

Eligibility Criteria

Inclusion

Inclusion Criteria: (list is not all inclusive)

  • Subject has given written informed consent and privacy authorization prior toparticipation in the study.

  • Subject has completed the Treatment Period of Study SEP361-308.

  • Subject has not taken any psychotropic medication other than the study drug,pre-switch antipsychotic and protocol-allowed medications during Study SEP361-308.

  • Female subject must have a negative rapid urine pregnancy test at the End ofTreatment (EOT) Visit of Study SEP361-308.

Exclusion

Exclusion Criteria: (list is not all inclusive)

  • Subject is suicidal based on the Columbia - Suicide Severity Rating Scale (C-SSRS)assessment at the End of Treatment (EOT) Visit of Study SEP361-308.

  • Subject has a clinically significant abnormality including physical examination,vital signs, or ECG finding at the End of Treatment (EOT) Visit of Study SEP361-308.

  • Subject has a positive rapid urine drug screen at the EOT Visit of Study SEP361-308.

  • Female subject is pregnant or lactating.

Study Design

Total Participants: 75
Treatment Group(s): 1
Primary Treatment: SEP-363856
Phase: 3
Study Start date:
March 31, 2023
Estimated Completion Date:
September 23, 2024

Study Description

This is a 24-week, outpatient, multicenter, flexible-dose, open-label extension study designed to evaluate the long-term safety and tolerability of SEP-363856 (50 to 100 mg/day) for the treatment of subjects with schizophrenia who have completed Study SEP361-308 treatment period, during which they were switched from a previous antipsychotic treatment to SEP-363856.

Connect with a study center

  • Advanced Research Center Inc.

    Anaheim, California 92805
    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

  • CNRI - San Diego, LLC

    San Diego, California 92102
    United States

    Site Not Available

  • CMB Clinical Trials

    Santee, California 92071
    United States

    Site Not Available

  • Collaborative Neuroscience Research, LLC

    Torrance, California 90502
    United States

    Site Not Available

  • Research Site

    Anaheim 5323810, California 5332921 92805
    United States

    Site Not Available

  • Research Site

    Bellflower 5327422, California 5332921 90706
    United States

    Site Not Available

  • Research Site

    Garden Grove 5351515, California 5332921 92845
    United States

    Site Not Available

  • Research Site

    Lemon Grove 5365893, California 5332921 91945
    United States

    Site Not Available

  • Research Site

    Santee 5393429, California 5332921 92071
    United States

    Site Not Available

  • Research Site

    Torrance 5403022, California 5332921 90502
    United States

    Site Not Available

  • Segal Trials, Larkin Behavioral / Adaptive Clinical Research

    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

  • Research Site

    Hollywood 4158928, Florida 4155751 33021
    United States

    Site Not Available

  • Research Site

    Miami 4164138, Florida 4155751 33122
    United States

    Site Not Available

  • Advanced Discovery Research LLC

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • Atlanta Center of Medical Research

    Atlanta, Georgia 30331
    United States

    Site Not Available

  • Research Site

    Atlanta 4180439, Georgia 4197000 30331
    United States

    Site Not Available

  • Uptown Research

    Chicago, Illinois 60640
    United States

    Site Not Available

  • Research Site

    Chicago 4887398, Illinois 4896861 60640
    United States

    Site Not Available

  • CBH Health

    Gaithersburg, Maryland 20877
    United States

    Site Not Available

  • Research Site

    Gaithersburg 4355843, Maryland 4361885 20877
    United States

    Site Not Available

  • PsychCare Consultants Research

    Saint Louis, Missouri 63128
    United States

    Site Not Available

  • Hassman Research Institute

    Berlin, New Jersey 08009
    United States

    Site Not Available

  • Research Site

    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

  • Research Site

    Charlotte 4460243, North Carolina 4482348 28211
    United States

    Site Not Available

  • Research Site

    Hickory 4470778, North Carolina 4482348 28601
    United States

    Site Not Available

  • Charak Clinical Research Center

    Garfield Heights, Ohio 44125
    United States

    Site Not Available

  • Research Site

    Richardson 4722625, Texas 4736286 75080
    United States

    Site Not Available

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