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New study tests Long-Term safety of schizophrenia drug in adolescents

NCT ID NCT03238326

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This completed Phase 3 trial tested the long-term safety of the drug brexpiprazole in 295 adolescents aged 13-17 with schizophrenia. Participants took flexible daily doses of the oral tablet for up to several months. The main goal was to track side effects and see how many teens stopped treatment due to problems. The study did not measure how well the drug worked, only its safety over time.

What this could mean

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

Active substance
brexpiprazole (a once-daily oral tablet for schizophrenia)
What this could lead to
If successful, this could confirm brexpiprazole as a safe long-term maintenance treatment for adolescents with schizophrenia.
What could go wrong
This is an open-label trial without a placebo group, so results may be less reliable. Side effects are possible, and the drug may not work for everyone.

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

295 people

The number who actually took part.

Started

Aug 2017

Finished

Apr 2025

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 17 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: * Male \& female subjects 13-17 years of age, inclusive. * Subjects who turn 18 during trial 331-10-234 are permitted in this trial. * Subjects with a current primary diagnosis of schizophrenia, as defined by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria and confirmed by the K-SADS-PL completed at time of entry into Trial 331-10-234. For de novo subjects who did not participate in Trial 331-10-234, the initial diagnosis of schizophrenia must be made and documented, and the diagnosis confirmed by the K-SADS-PL at screening. * Subjects who, in the investigator's judgment, require treatment with antipsychotic medication(s). Exclusion Criteria: * Subjects with a DSM-5 diagnosis other than schizophrenia that has been the primary focus of treatment within 3 months of screening * Subjects with a clinical presentation or history that is consistent with delirium, dementia, amnesia, or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (e.g., medication, illicit drug use). * History of failure of clozapine treatment or response to clozapine treatment only. * History of neuroleptic malignant syndrome

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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

  • Clinical Research Site #100

    Rochester, New York, 14618, United States

  • Clinical Research Site #101

    Dothan, Alabama, 36303, United States

  • Clinical Research Site #102

    Oklahoma City, Oklahoma, 73116, United States

  • Clinical Research Site #103

    Long Beach, California, 90807, United States

  • Clinical Research Site #105

    Culver City, California, 90230, United States

  • Clinical Research Site #108

    Everett, Washington, 98201, United States

  • Clinical Research Site #113

    Garfield Heights, Ohio, 44125, United States

  • Clinical Research Site #121

    Kinston, North Carolina, 28501, United States

  • Clinical Research Site #124

    Las Vegas, Nevada, 89109, United States

  • Clinical Research Site #128

    Anaheim, California, 92805, United States

  • Clinical Research Site #130

    New York, New York, 10036, United States

  • Clinical Research Site #133

    Cincinnati, Ohio, 45219, United States

  • Clinical Research Site #135

    Tulsa, Oklahoma, 74136, United States

  • Clinical Research Site #136

    Atlanta, Georgia, 30331, United States

  • Clinical Research Site #138

    Lake Charles, Louisiana, 70629, United States

  • Clinical Research Site #140

    Frisco, Texas, 75034, United States

  • Clinical Research Site #148

    Kansas City, Kansas, 66160, United States

  • Clinical Research Site #160

    Monterrey, Nuevo León, 64710, Mexico

  • Clinical Research Site #161

    Culiacán, Sinaloa, 80230, Mexico

  • Clinical Research Site #163

    León, Guanajuato, 37000, Mexico

  • Clinical Research Site #165

    Guadalajara, Jalisco, 44100, Mexico

  • Clinical Research Site #166

    Mérida, Yucatán, 97070, Mexico

  • Clinical Research Site #168

    Durango, 34000, Mexico

  • Clinical Research Site #170

    San Luis Potosí City, San Luis Potosí, 78213, Mexico

  • Clinical Research Site #171

    Monterrey, Nuevo León, 64310, Mexico

  • Clinical Research Site #224

    Torremolinos, Malaga, 29620, Spain

  • Clinical Research Site #241

    Cluj-Napoca, 400660, Romania

  • Clinical Research Site #242

    Timișoara, 300329, Romania

  • Clinical Research Site #243

    Iași, IS700282, Romania

  • Clinical Research Site #244

    Bucharest, 041914, Romania

  • Clinical Research Site #260

    Poznan, 60-744, Poland

  • Clinical Research Site #263

    Tyniec Mały, Dolnyslask, 55-040, Poland

  • Clinical Research Site #266

    Bialystok, Podlaskie Voivodeship, 15-879, Poland

  • Clinical Research Site #267

    Wroclaw, 54-617, Poland

  • Clinical Research Site #269

    Gdansk, Polorskie, 80-542, Poland

  • Clinical Research Site #270

    Wałbrzych, 58-309, Poland

  • Clinical Research Site #272

    Poznan, 61-485, Poland

  • Clinical Research Site #283

    Naples, 80131, Italy

  • Clinical Research Site #321

    Nice, 06200, France

  • Clinical Research Site #500

    Belgrade, 11000, Serbia

  • Clinical Research Site #501

    Novi Sad, 21000, Serbia

  • Clinical Research Site #502

    Niš, 18000, Serbia

  • Clinical Research Site #503

    Kragujevac, 34000, Serbia

  • Clinical Research Site #504

    Belgrade, 11000, Serbia

  • Clinical Research Site #520

    Lviv, 79021, Ukraine

  • Clinical Research Site #521

    Kharkiv, 61153, Ukraine

  • Clinical Research Site #522

    Kherson, 73488, Ukraine

  • Clinical Research Site #523

    Kharkiv, 61068, Ukraine

  • Clinical Research Site #525

    Ternopil, 46027, Ukraine

  • Clinical Research Site #526

    Poltava, Poltava Oblast, 36013, Ukraine

  • Clinical Research Site #527

    Dnipro, 49027, Ukraine

  • Clinical Research Site #540

    Saint Petersburg, 197341, Russia

  • Clinical Research Site #541

    Saint Petersburg, 192019, Russia

  • Clinical Research Site #542

    Arkhangelsk, Primorsky District, 163530, Russia

  • Clinical Research Site #543

    Stavropol, Stavropolskiy Kray, 355038, Russia

  • Clinical Research Site #544

    Yaroslavl, 150003, Russia

  • Clinical Research Site #545

    Moscow, 127083, Russia

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