Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia
NCT ID: NCT03238326
Last Updated: 2025-05-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
295 participants
INTERVENTIONAL
2017-08-23
2025-08-05
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
NCT03287869
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder
NCT03257865
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes Associated With Bipolar I Disorder
NCT03259555
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
NCT03292848
Evaluating the Safety and Tolerability of Brexpiprazole in the Treatment of Adults With Borderline Personality Disorder (BPD)
NCT04186403
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rollover & De-Novo
1-4 mg/day; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day
Brexpiprazole
Once daily, oral tablets
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Brexpiprazole
Once daily, oral tablets
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
13 Years
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
H. Lundbeck A/S
INDUSTRY
Otsuka Pharmaceutical Development & Commercialization, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Heather Guthrie, MD
Role: STUDY_DIRECTOR
Otsuka Pharmaceutical Development & Commercialization, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Clinical Research Site #101
Dothan, Alabama, United States
Clinical Research Site #128
Anaheim, California, United States
Clinical Research Site #105
Culver City, California, United States
Clinical Research Site #103
Long Beach, California, United States
Clinical Research Site #136
Atlanta, Georgia, United States
Clinical Research Site #148
Kansas City, Kansas, United States
Clinical Research Site #138
Lake Charles, Louisiana, United States
Clinical Research Site #124
Las Vegas, Nevada, United States
Clinical Research Site #130
New York, New York, United States
Clinical Research Site #100
Rochester, New York, United States
Clinical Research Site #121
Kinston, North Carolina, United States
Clinical Research Site #133
Cincinnati, Ohio, United States
Clinical Research Site #113
Garfield Heights, Ohio, United States
Clinical Research Site #102
Oklahoma City, Oklahoma, United States
Clinical Research Site #135
Tulsa, Oklahoma, United States
Clinical Research Site #140
Frisco, Texas, United States
Clinical Research Site #108
Everett, Washington, United States
Clinical Research Site #321
Nice, , France
Clinical Research Site #283
Naples, , Italy
Clinical Research Site #163
León, Guanajuato, Mexico
Clinical Research Site #165
Guadalajara, Jalisco, Mexico
Clinical Research Site #171
Monterrey, Nuevo León, Mexico
Clinical Research Site #160
Monterrey, Nuevo León, Mexico
Clinical Research Site #170
San Luis Potosí City, San Luis Potosí, Mexico
Clinical Research Site #161
Culiacán, Sinaloa, Mexico
Clinical Research Site #166
Mérida, Yucatán, Mexico
Clinical Research Site #168
Durango, , Mexico
Clinical Research Site #263
Tyniec Mały, Dolnyslask, Poland
Clinical Research Site #266
Bialystok, Podlaskie Voivodeship, Poland
Clinical Research Site #269
Gdansk, Polorskie, Poland
Clinical Research Site #260
Poznan, , Poland
Clinical Research Site #272
Poznan, , Poland
Clinical Research Site #270
Wałbrzych, , Poland
Clinical Research Site #267
Wroclaw, , Poland
Clinical Research Site #244
Bucharest, , Romania
Clinical Research Site #241
Cluj-Napoca, , Romania
Clinical Research Site #243
Iași, , Romania
Clinical Research Site #242
Timișoara, , Romania
Clinical Research Site #542
Arkhangelsk, Primorsky District, Russia
Clinical Research Site #543
Stavropol, Stavropolskiy Kray, Russia
Clinical Research Site #545
Moscow, , Russia
Clinical Research Site #541
Saint Petersburg, , Russia
Clinical Research Site #540
Saint Petersburg, , Russia
Clinical Research Site #544
Yaroslavl, , Russia
Clinical Research Site #500
Belgrade, , Serbia
Clinical Research Site #504
Belgrade, , Serbia
Clinical Research Site #503
Kragujevac, , Serbia
Clinical Research Site #502
Niš, , Serbia
Clinical Research Site #501
Novi Sad, , Serbia
Clinical Research Site #224
Torremolinos, Malaga, Spain
Clinical Research Site #526
Poltava, Poltava Oblast, Ukraine
Clinical Research Site #527
Dnipro, , Ukraine
Clinical Research Site #523
Kharkiv, , Ukraine
Clinical Research Site #521
Kharkiv, , Ukraine
Clinical Research Site #522
Kherson, , Ukraine
Clinical Research Site #520
Lviv, , Ukraine
Clinical Research Site #525
Ternopil, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Atkinson SD, Shah A, Burgess MV, Hefting N, Chen D, Ward C. Safety and Tolerability of Brexpiprazole in Adolescents With Schizophrenia: A Long-Term, Open-Label Study. JAACAP Open. 2024 May 27;3(2):313-322. doi: 10.1016/j.jaacop.2024.04.005. eCollection 2025 Jun.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
331-10-236
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.