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

NCT ID NCT03238326

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

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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

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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