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New schizophrenia drug shows promise in major trial

NCT ID NCT04072354

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 investigational drug called SEP-363856 in 463 people with schizophrenia who were having severe symptoms. Participants received either the drug or a placebo for 6 weeks. The main goal was to see if the drug reduced symptoms like hallucinations and emotional withdrawal better than a placebo.

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

463 people

The number who actually took part.

Started

Sep 2019

Finished

Sep 2023

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

13 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: 1. Male or female subject between 13 to 65 years of age (inclusive) at the time of consent. 2. Subject or subjects parent/legal guardian \[adolescents\] must give written informed consent and privacy authorization prior to participate in the study; adolescents must also provide informed assent.. 3. Subject meets DSM-5 criteria for schizophrenia as established by clinical interview at screening 4. Subject must have a CGI-S score ≥ 4 5. Subject must have a PANSS total score ≥ 80 and a PANSS item score ≥ 4 on 2 or more of the following PANSS items: delusions, conceptual disorganization, hallucinations, and unusual thought content 6. Subject has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent). 7. Subject has marked deterioration of functioning in one or more areas. 8. Subject is, in the opinion of the Investigator, generally healthy based on screening medical history, PE, neurological examination, vital signs, ECG, and clinical laboratory values. Exclusion Criteria: 1. Subject has a 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 of the brain or other body systems, major depressive disorder, bipolar I or II disorder, schizoaffective disorder, obsessive compulsive disorder, and posttraumatic stress disorder. Symptoms of mild to moderate mood dysphoria or anxiety are allowed so long as these symptoms are not the primary focus of treatment. 2. Subject is at significant risk of harming self, others, or objects based on Investigator's judgment. 3. Subject has any clinically significant unstable medical condition or any clinically significant chronic disease that in the opinion of the Investigator, would limit the subject's ability to complete and/or participate in the study: 4. Female subject who is pregnant or lactating 5. Subject has any clinically significant abnormal laboratory value(s) at Screening as determined by the 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

    Little Rock, Arkansas, 72211, United States

  • Research Site

    Anaheim, California, 92805, United States

  • Research Site

    Bellflower, California, 90706, United States

  • Research Site

    Lemon Grove, California, 91945, United States

  • Research Site

    Long Beach, California, 90807, United States

  • Research Site

    Montclair, California, 91763, United States

  • Research Site

    Pico Rivera, California, 90660, United States

  • Research Site

    San Diego, California, 92103, United States

  • Research Site

    Hollywood, Florida, 33021, United States

  • Research Site

    Hollywood, Florida, 33024, United States

  • Research Site

    Miami Springs, Florida, 33166, United States

  • Research Site

    Atlanta, Georgia, 30318, United States

  • Research Site

    Atlanta, Georgia, 30331, United States

  • Research Site

    Decatur, Georgia, 30030, United States

  • Research Site

    Gaithersburg, Maryland, 20877, United States

  • Research Site

    Flowood, Mississippi, 39232, United States

  • Research Site

    Dayton, Ohio, 45417, United States

  • Research Site

    Austin, Texas, 78754, United States

  • Research Site

    Pazardzhik, 4400, Bulgaria

  • Research Site

    Pleven, 5800, Bulgaria

  • Research Site

    Sofia, 1202, Bulgaria

  • Research Site

    Sofia, 1431, Bulgaria

  • Research Site

    Veliko Tarnovo, 5000, Bulgaria

  • Research Site

    Vratsa, 3000, Bulgaria

  • Research Site

    Bello, Antioquia, 051053, Colombia

  • Research Site

    Bogotá, 111166, Colombia

  • Research Site

    Bogotá, Colombia

  • Research Site

    Chelyabinsk, 454087, Russia

  • Research Site

    Moscow, 107076, Russia

  • Research Site

    Nizniy Novgorod, 603155, Russia

  • Research Site

    Petrozavodsk, 186131, Russia

  • Research Site

    Saint Petersburg, 092019, Russia

  • Research Site

    Saint Petersburg, 192019, Russia

  • Research Site

    Samara, 443016, Russia

  • Research Site

    Saratov, 410028, Russia

  • Research Site

    Belgrade, 11000, Serbia

  • Research Site

    Gornja Toponica, 18202, Serbia

  • Research Site

    Kovin, 26220, Serbia

  • Research Site

    Kragujevac, 34000, Serbia

  • Research Site

    Niš, 18000, Serbia

  • Research Site

    Novi Kneževac, 23330, Serbia

  • Research Site

    Novi Sad, 21000, Serbia

  • Research Site

    Vršac, 26300, Serbia

  • Research Site

    Ivano-Frankivsk, 76011, Ukraine

  • Research Site

    Kropyvnytskyi, 25491, Ukraine

  • Research Site

    Kyiv, 02192, Ukraine

  • Research Site

    Kyiv, 04080, Ukraine

  • Research Site

    Lviv, 79021, Ukraine

  • Research Site

    Odesa, 65006, Ukraine

  • Research Site

    Odesa, 67513, Ukraine

  • Research Site

    Poltava, 36013, Ukraine

  • Research Site

    Smila, 20708, Ukraine

  • Research Site

    Vinnytsia, 21005, Ukraine

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