Trial to Evaluate the Short-term Safety & Efficacy of Brexpiprazole Monotherapy in the Treatment of Adolescents With Schizophrenia

Study Identifier:
331-10-234
ClinicalTrials.gov Identifier:
NCT03198078
EudraCT Identifier:
2017-001447-12
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Results Availables

Study Protocol
Available Language: English
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Statistical Analysis Plan
Available Language: English
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Study Details

Medical Condition
  • Schizophrenia
Study Drug
  • Drug: Brexpiprazole (OPC-34712)
  • Drug: Aripiprazole
  • Drug: Placebo
Date
Jun 2017 - Apr 2023
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 13 - 17 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male \& female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to screening.
  • PANSS score \>= 80, inclusive, at screening and baseline
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 who have been hospitalized \> 21 days for a current exacerbation of schizophrenia at the time of baseline.
  • Any neurological disorder other than Tourette's Syndrome
  • Subjects at significant risk of committing violent acts, serious self-harm or suicide based on history
  • Subjects with epilepsy, a history of seizures, severe head trauma or stroke
  • Subjects who test positive for drugs of abuse at screening

Protocol Summary

To determine the safety \& efficacy of brexpiprazole monotherapy in the treatment of adolescents with schizophrenia.

Study Locations

Location
Status
Location
For additional information regarding sites, contact 844-687-8522
Oklahoma City, Oklahoma, United States, 73116
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Male \& female subjects aged 13-17 years, inclusive at time of consent and at baseline visit, with a primary diagnosis of schizophrenia as defined by DSM-5 criteria and confirmed by K-SADS-PL and a history of the illness for at least 6 months prior to screening.
  • PANSS score \>= 80, inclusive, at screening and baseline
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 who have been hospitalized \> 21 days for a current exacerbation of schizophrenia at the time of baseline.
  • Any neurological disorder other than Tourette's Syndrome
  • Subjects at significant risk of committing violent acts, serious self-harm or suicide based on history
  • Subjects with epilepsy, a history of seizures, severe head trauma or stroke
  • Subjects who test positive for drugs of abuse at screening

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