Safety and Tolerability of Open-Label Flexible-dose Brexpiprazole as Maintenance Treatment in Adolescents With Schizophrenia

NCT03238326 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: 331-10-236
• Study Type: interventional
• Target: 295
• Locations: 10 countries
• Sites: 57

Brief Summary

To further characterize the long-term safety and tolerability of brexpiprazole in adolescents with schizophrenia

Conditions

Schizophrenia

Keywords

Brexpiprazole; Schizophrenia

Outcome Measures

Primary Outcomes (3)

• Number of Participants With Adverse Events (AEs)

  An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment.

  From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months).

• Number of Participants With Serious Treatment Emergent Adverse Events (TEAEs)

  An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. A serious adverse event (SAE) is any AE occurring at any dose that results in death, life-threatening experience, persistent or significant disability/incapacity, in-patient hospitalization or prolongs hospitalization or congenital anomaly/birth defect. A serious TEAE is defined as an AE that occurred or worsened after the first dose of study treatment up until 30 days after the last dose.

  From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months).

• Number of Participants Who Discontinued the Trial Due to AEs

  An AE is defined as any untoward medical occurrence in a clinical trial participant administered a medicinal product and which does not necessarily have a causal relationship with the study treatment. Participants who discontinued the trial due to AEs were recorded.

  From the first dose of study drug (including the conversion period and the open-label treatment period in the current study) up to 21 days after the last dose of study drug (up to approximately 25.6 months).

Secondary Outcomes (33)

• Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Units Per Liter)

  From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24)

• Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Milligrams Per Deciliter)

  From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24)

• Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Percentage)

  From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24)

• Mean Change From Baseline in Laboratory Tests (Parameters Assessed in Million Cells Per Microliter)

  From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24)

• Mean Change From Baseline in Clinical Laboratory Tests (Parameters Assessed in Thousand Cells Per Microliter)

  From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24)

Other Outcomes (1)

• Time to Discontinuation Due to AEs

  From the first dose of the study drug up to the last dose in the open-label treatment period (Up to Month 24)

Study Arms (5)

De Novo (Conversion Period)

EXPERIMENTAL

1-3 milligrams/day (mg/day) brexpiprazole for 1 to 4 weeks

Drug: Brexpiprazole

Prior and Current Brexpiprazole (Open-label Treatment Period)

EXPERIMENTAL

1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day

Drug: Brexpiprazole

Prior Aripiprazole and Current Brexpiprazole (Open-label Treatment Period)

EXPERIMENTAL

1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day

Drug: Brexpiprazole

Prior Placebo and Current Brexpiprazole (Open-label Treatment Period)

EXPERIMENTAL

1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day

Drug: Brexpiprazole

De Novo (Open-label Treatment Period)

EXPERIMENTAL

1-4 mg/day brexpiprazole; Start at 0.5 mg/day, titrate and maintain between 1mg/day to max of 4 mg/day

Drug: Brexpiprazole

Interventions

Brexpiprazole DRUG

Once daily, oral tablets

Also known as: OPC-34712

De Novo (Conversion Period); De Novo (Open-label Treatment Period); Prior Aripiprazole and Current Brexpiprazole (Open-label Treatment Period); Prior Placebo and Current Brexpiprazole (Open-label Treatment Period); Prior and Current Brexpiprazole (Open-label Treatment Period)

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead
• H. Lundbeck A/S: collaborator

Study Sites (57)

Clinical Research Site #101

Dothan, Alabama, 36303, United States

Location

Clinical Research Site #128

Anaheim, California, 92805, United States

Location

Clinical Research Site #105

Culver City, California, 90230, United States

Location

Clinical Research Site #103

Long Beach, California, 90807, United States

Location

Clinical Research Site #136

Atlanta, Georgia, 30331, United States

Location

Clinical Research Site #148

Kansas City, Kansas, 66160, United States

Location

Clinical Research Site #138

Lake Charles, Louisiana, 70629, United States

Location

Clinical Research Site #124

Las Vegas, Nevada, 89109, United States

Location

Clinical Research Site #130

New York, New York, 10036, United States

Location

Clinical Research Site #100

Rochester, New York, 14618, United States

Location

Clinical Research Site #121

Kinston, North Carolina, 28501, United States

Location

Clinical Research Site #133

Cincinnati, Ohio, 45219, United States

Location

Clinical Research Site #113

Garfield Heights, Ohio, 44125, United States

Location

Clinical Research Site #102

Oklahoma City, Oklahoma, 73116, United States

Location

Clinical Research Site #135

Tulsa, Oklahoma, 74136, United States

Location

Clinical Research Site #140

Frisco, Texas, 75034, United States

Location

Clinical Research Site #108

Everett, Washington, 98201, United States

Location

Clinical Research Site #321

Nice, 06200, France

Location

Clinical Research Site #283

Naples, 80131, Italy

Location

Clinical Research Site #163

León, Guanajuato, 37000, Mexico

Location

Clinical Research Site #165

Guadalajara, Jalisco, 44100, Mexico

Location

Clinical Research Site #171

Monterrey, Nuevo León, 64310, Mexico

Location

Clinical Research Site #160

Monterrey, Nuevo León, 64710, Mexico

Location

Clinical Research Site #170

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

Location

Clinical Research Site #161

Culiacán, Sinaloa, 80230, Mexico

Location

Clinical Research Site #166

Mérida, Yucatán, 97070, Mexico

Location

Clinical Research Site #168

Durango, 34000, Mexico

Location

Clinical Research Site #263

Tyniec Mały, Dolnyslask, 55-040, Poland

Location

Clinical Research Site #266

Bialystok, Podlaskie Voivodeship, 15-879, Poland

Location

Clinical Research Site #269

Gdansk, Polorskie, 80-542, Poland

Location

Clinical Research Site #260

Poznan, 60-744, Poland

Location

Clinical Research Site #272

Poznan, 61-485, Poland

Location

Clinical Research Site #270

Wałbrzych, 58-309, Poland

Location

Clinical Research Site #267

Wroclaw, 54-617, Poland

Location

Clinical Research Site #244

Bucharest, 041914, Romania

Location

Clinical Research Site #241

Cluj-Napoca, 400660, Romania

Location

Clinical Research Site #243

Iași, IS700282, Romania

Location

Clinical Research Site #242

Timișoara, 300329, Romania

Location

Clinical Research Site #542

Arkhangelsk, Primorsky District, 163530, Russia

Location

Clinical Research Site #543

Stavropol, Stavropolskiy Kray, 355038, Russia

Location

Clinical Research Site #545

Moscow, 127083, Russia

Location

Clinical Research Site #541

Saint Petersburg, 192019, Russia

Location

Clinical Research Site #540

Saint Petersburg, 197341, Russia

Location

Clinical Research Site #544

Yaroslavl, 150003, Russia

Location

Clinical Research Site #500

Belgrade, 11000, Serbia

Location

Clinical Research Site #504

Belgrade, 11000, Serbia

Location

Clinical Research Site #503

Kragujevac, 34000, Serbia

Location

Clinical Research Site #502

Niš, 18000, Serbia

Location

Clinical Research Site #501

Novi Sad, 21000, Serbia

Location

Clinical Research Site #224

Torremolinos, Malaga, 29620, Spain

Location

Clinical Research Site #526

Poltava, Poltava Oblast, 36013, Ukraine

Location

Clinical Research Site #527

Dnipro, 49027, Ukraine

Location

Clinical Research Site #523

Kharkiv, 61068, Ukraine

Location

Clinical Research Site #521

Kharkiv, 61153, Ukraine

Location

Clinical Research Site #522

Kherson, 73488, Ukraine

Location

Clinical Research Site #520

Lviv, 79021, Ukraine

Location

Clinical Research Site #525

Ternopil, 46027, Ukraine

Location

Related Publications (1)

• 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.

  PMID: 40520975 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

brexpiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Clinical Transparency
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

08446878522

Study Officials

• Heather Guthrie, MD

  Otsuka Pharmaceutical Development & Commercialization, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 3, 2017
• Study Start: August 23, 2017
• Primary Completion: April 22, 2025
• Study Completion: April 22, 2025
• Last Updated: February 4, 2026
• Results First Posted: February 4, 2026

Record last verified: 2026-01

Locations

IT (1); SE (5); US (17); FR (1); RO (4); ME (8); UA (7); ES (1); PL (7); RU (6)