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New hope for schizophrenia: study tests switching to SEP-363856

NCT ID NCT05628103

Disease control Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how well a new drug, SEP-363856, works and how safe it is for people with schizophrenia who switch from their current antipsychotic medication. About 101 adults with stable schizophrenia took part over 8 weeks. The main goal was to see how many stopped the study due to side effects or lack of benefit.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

101 people

The number who actually took part.

Started

Dec 2022

Finished

Apr 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: This list is not all inclusive * 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. Exclusion Criteria:This list is not all inclusive * 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.

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Schizophrenia

Contacts and locations

Locations

  • Advanced Discovery Research LLC

    Atlanta, Georgia, 30318, United States

  • Advanced Research Center, Inc.

    Anaheim, California, 92805, United States

  • Atlanta Behavioral Research

    Atlanta, Georgia, 30358, United States

  • Atlanta Center for Medical Research

    Atlanta, Georgia, 30331, United States

  • CBH Health

    Gaithersburg, Maryland, 20877, United States

  • CMB Clinical Trials

    Santee, California, 92071, United States

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

    San Diego, California, 92102, United States

  • Cenexel CNS Research

    Torrance, California, 90502, United States

  • Charak Clinical Research Center

    Garfield Heights, Ohio, 44125, United States

  • Clinical Innovations Inc.

    Bellflower, California, 90706, United States

  • Clinical Innovations, Inc

    Riverside, California, 92506, United States

  • Clinical Trials of America, LLC

    Hickory, North Carolina, 28601, United States

  • Collaborative Neuroscience Research, LLC

    Garden Grove, California, 92845, United States

  • Hassman Research Institute

    Berlin, New Jersey, 08009, United States

  • IMA Clinical Research

    Las Vegas, Nevada, 89102, United States

  • Larkin Behavioral Health Services

    Hollywood, Florida, 33021, United States

  • New Hope Clinical Research

    Charlotte, North Carolina, 28211, United States

  • Nova Psychiatry, Inc.

    Orlando, Florida, 32803, United States

  • Pillar Clinical Research, LLC

    Richardson, Texas, 75080, United States

  • Premier Clinical Research Institute, Inc.

    Miami, Florida, 33122, United States

  • ProScience Research Group

    Culver City, California, 90230, United States

  • PsychCare Consultants Research

    St Louis, Missouri, 63128, United States

  • Synergy San Diego

    Lemon Grove, California, 91945, United States

  • Uptown Research

    Chicago, Illinois, 60640, United States

  • Wellness Research Center

    Miami, Florida, 33135, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.