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New schizophrenia drug shows promise in large trial

NCT ID NCT04092686

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Phase 3 trial tested an investigational drug called SEP-363856 in 464 people with schizophrenia who were experiencing acute psychosis. Participants received either the drug or a placebo daily for up to 9 weeks. The study measured changes in symptoms like hallucinations and delusions using standard psychiatric scales. The goal was to see if the drug could safely reduce symptom severity compared to placebo.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SEP-363856 (an investigational drug for schizophrenia)
What this could lead to
If successful, this drug could offer a new treatment option to reduce psychotic symptoms like hallucinations and delusions in people with schizophrenia.
What could go wrong
This is a Phase 3 trial, but results are not yet published. The drug may not work better than placebo, and side effects are possible. It is not a cure.

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

464 people

The number who actually took part.

Started

Oct 2019

Finished

Jun 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

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: 1. Male or female participant between 18 to 65 years of age (inclusive) at the time of consent. 2. Participant must give written informed consent and privacy authorization prior to participation in the study. 3. Participant meets the Diagnostic and Statistical Manual of Mental Illnesses (DSM-5 )criteria for schizophrenia as established by clinical interview at screeing. 4. Participant must have a Clinical Global Impression - Severity (CGI-S) score ≥ 4. 5. Participant must have a Positive and Negative Syndrome Scale (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. Participant has an acute exacerbation of psychotic symptoms (persisting no longer than 2 months prior to providing informed consent). 7. Participant has marked deterioration of functioning in one or more areas. 8. Participant is, in the opinion of the Investigator, generally healthy based on screening medical history, physical examination (PE), neurological examination, vital signs, electrocardiogram (ECG) and clinical laboratory values. Exclusion Criteria: 1. Participant 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 on 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. Participant is at significant risk of harming self, others, or objects based on Investigator's judgment. 3. 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 4. Female participant who is pregnant or lactating 5. 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

    Rogers, Arkansas, 72758, United States

  • Research Site

    Anaheim, California, 92805, United States

  • Research Site

    Bellflower, California, 90706, United States

  • Research Site

    Culver City, California, 90230, United States

  • Research Site

    Long Beach, California, 90806, United States

  • Research Site

    San Diego, California, 92102, United States

  • Research Site

    Sherman Oaks, California, 91403, United States

  • Research Site

    Hollywood, Florida, 33021, United States

  • Research Site

    Miami Springs, Florida, 33166, United States

  • Research Site

    Atlanta, Georgia, 30331, United States

  • Research Site

    Decatur, Georgia, 30030, United States

  • Research Site

    Chicago, Illinois, 60641, United States

  • Research Site

    Lake Charles, Louisiana, 70629, United States

  • Research Site

    Gaithersburg, Maryland, 20877, United States

  • Research Site

    St Louis, Missouri, 63125, United States

  • Research Site

    Marlton, New Jersey, 08053, United States

  • Research Site

    New York, New York, 10032, United States

  • Research Site

    Richardson, Texas, 75080, United States

  • Research Site

    Burgas, 8000, Bulgaria

  • Research Site

    Kardzhali, 6600, Bulgaria

  • Research Site

    Novi Iskar, 1282, Bulgaria

  • Research Site

    Plovdiv, 4000, Bulgaria

  • Research Site

    Sofia, 1202, Bulgaria

  • Research Site

    Sofia, 1431, Bulgaria

  • Research Site

    Zagreb, 10090, Croatia

  • Research Site

    Daugavpils, LV-5417, Latvia

  • Research Site

    Riga, LV-1005, Latvia

  • Research Site

    Strenči, LV-4730, Latvia

  • Research Site

    Arkhangelsk, 163530, Russia

  • Research Site

    Engel's, 413124, Russia

  • Research Site

    Moscow, 117152, Russia

  • Research Site

    Moscow, 141371, Russia

  • Research Site

    Saint Petersburg, 188820, Russia

  • Research Site

    Saint Petersburg, 190005, Russia

  • Research Site

    Saint Petersburg, 192019, Russia

  • Research Site

    Saint Petersburg, 197341, Russia

  • Research Site

    Saratov, 410028, Russia

  • Research Site

    Saratov, 410060, Russia

  • Research Site

    Stavropol, 357034, Russia

  • Research Site

    Tomsk, 634014, Russia

  • Research Site

    Belgrade, 11000, Serbia

  • Research Site

    Kovin, 26220, Serbia

  • Research Site

    Kragujevac, 34000, Serbia

  • Research Site

    Niš, 18000, Serbia

  • Research Site

    Novi Kneževac, 23330, Serbia

  • Research Site

    Vršac, 26300, Serbia

  • Research Site

    Kharkiv, 61068, Ukraine

  • Research Site

    Kherson, 73488, Ukraine

  • Research Site

    Kyiv, 01030, Ukraine

  • Research Site

    Kyiv, 01133, Ukraine

  • Research Site

    Kyiv, 08631, Ukraine

  • Research Site

    Lviv, 79021, Ukraine

  • Research Site

    Vinnytsia, 21005, Ukraine

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