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New schizophrenia drug passes long-term safety check

NCT ID NCT04115319

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested an experimental drug called SEP-363856 to see if it is safe to take for a long time by people with schizophrenia. 305 adults aged 18 to 65 took part for about 57 weeks. The main goal was to track any side effects or serious health problems that happened while on the drug.

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

305 people

The number who actually took part.

Started

Nov 2019

Finished

Dec 2022

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: The main inclusion criteria include, but are not limited to the following: * Male or female participant between 18 to 65 years of age (inclusive) at the time of consent. * Participant meets DSM-5 criteria for a diagnosis of schizophrenia as established by clinical interview at screening (using the DSM-5 as a reference and confirmed using the SCID-CT). The time since the participant's diagnosis must be ≥ 1 year prior to Screening. * Participant must have a CGI-S score ≤ 4 at Screening and Baseline. * Participant must have a PANSS total score ≤ 80 at Screening and Baseline. * Participant is judged to be clinically stable (i.e., no evidence of an acute exacerbation) by the Investigator for at least 8 weeks prior to Screening. * Participant has had no change in antipsychotic medication(s) (minor dose adjustments for tolerability purposes are permitted) for at least 6 weeks prior to Screening. * Participants taking an antipsychotic agent at Screening may participate in this study only if there are signs of intolerability or lack of efficacy of the current antipsychotic (as determined by the Investigator). * Participant is, in the opinion of the Investigator, generally healthy based on Screening medical history, PE, neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values (hematology, chemistry and urinalysis). Exclusion criteria: Main exclusion criteria include, but are not limited to: * Participant was hospitalized for a psychiatric illness within the 8 weeks prior to Screening. * Participant has a current DSM-5 diagnosis or presence of symptoms consistent with a DSM-5 diagnosis other than schizophrenia. Exclusionary disorders include but are not limited to alcohol use disorder (within past 12 months), substance (other than nicotine or caffeine) use disorder within past 12 months, or lifetime history of significant substance abuse that, in the opinion of the Investigator or Sponsor, may have had a significant and potentially permanent impact on the brain or other body systems, major depressive disorder, schizoaffective disorder, ,bipolar I or II disorder, obsessive compulsive disorder, and posttraumatic stress disorder, symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as theses symptoms are not the primary focus of treatment. * Participant is judged to be resistant to antipsychotic treatment by the Investigator, based on failure to respond to 2 or more marketed antipsychotic agents within a 1-year period prior to Screening, given at adequate dose as per labeling, for at least 4 weeks. * Participant answers "yes" to "Suicidal Ideation" Item 4 (active suicidal ideation with some intent to act, without specific plan) or Item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at Screening (i.e., in the past one month) or at Baseline (i.e., since last visit). * Participant is at significant risk of harming self or others based on Investigator's judgment. * Participant has attempted suicide within 6 months prior to Screening. * Participant has received treatment with a psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer) * Participant has been treated with quetiapine or quetiapine XR within the 6 weeks prior to Screening or has a history of inadequate response or intolerability to quetiapine or quetiapine XR. * 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. * Participant has any clinically significant abnormal laboratory value(s) at Screening as determined by investigator.

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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

  • Research Site

    Cerritos, California, 90703, United States

  • Research Site

    Oakland, California, 94607, United States

  • Research Site

    Oceanside, California, 92056, United States

  • Research Site

    San Diego, California, 92103, United States

  • Research Site

    Torrance, California, 90502, United States

  • Research Site

    Miami, Florida, 33122, United States

  • Research Site

    Miami Lakes, Florida, 33016, United States

  • Research Site

    Atlanta, Georgia, 30328, United States

  • Research Site

    Hoffman Estates, Illinois, 60169, United States

  • Research Site

    Lincolnwood, Illinois, 60712, United States

  • Research Site

    Shreveport, Louisiana, 71101, United States

  • Research Site

    St Louis, Missouri, 63128, United States

  • Research Site

    Las Vegas, Nevada, 89102, United States

  • Research Site

    Cedarhurst, New York, 11516, United States

  • Research Site

    Jamaica, New York, 11432, United States

  • Research Site

    Rochester, New York, 14618, United States

  • Research Site

    Charlotte, North Carolina, 28211, United States

  • Research Site

    North Canton, Ohio, 44720, United States

  • Research Site

    Brasov, 500079, Romania

  • Research Site

    Bucharest, 041914, Romania

  • Research Site

    Bucharest, 060222, Romania

  • Research Site

    Bucharest, 41914,, Romania

  • Research Site

    Iași, 700282, Romania

  • Research Site

    Arkhangelsk, 163530, Russia

  • Research Site

    Moscow, 127083, Russia

  • Research Site

    Omsk, 644070, Russia

  • Research Site

    Saint Petersburg, 188357, Russia

  • Research Site

    Saint Petersburg, 190121, Russia

  • Research Site

    Saint Petersburg, 192019, Russia

  • Research Site

    Saint Petersburg, 195176, Russia

  • Research Site

    Saint Petersburg, 199106, Russia

  • Research Site

    Smolensk, 214031, Russia

  • Research Site

    Stavropol, 357034, Russia

  • Research Site

    Tomsk, 634014, Russia

  • Research Site

    Yaroslavl, 150003, Russia

  • Research Site

    Yekaterinburg, 620030, Russia

  • Research Site

    Ivano-Frankivsk, 76011, Ukraine

  • Research Site

    Kharkiv, 61068, Ukraine

  • Research Site

    Kyiv, 03049, Ukraine

  • Research Site

    Smila, 20708, Ukraine

  • Research Site

    Ternopil, 46027, Ukraine

  • Research Site

    Uzhhorod, 88000, Ukraine

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