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

Study Identifier:
331-10-236
ClinicalTrials.gov Identifier:
NCT03238326
EudraCT Identifier:
N/A
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
Date
Aug 2017 - Apr 2025
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 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

Protocol Summary

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

Study Locations

Location
Status
Location
Clinical Research Site #101
Dothan, Alabama, United States, 36303
Status
N/A
Location
Clinical Research Site #128
Anaheim, California, United States, 92805
Status
N/A
Location
Clinical Research Site #105
Culver City, California, United States, 90230
Status
N/A
Location
Clinical Research Site #103
Long Beach, California, United States, 90807
Status
N/A
Location
Clinical Research Site #136
Atlanta, Georgia, United States, 30331
Status
N/A
Location
Clinical Research Site #148
Kansas City, Kansas, United States, 66160
Status
N/A
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Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
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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