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

Sponsor ID
331-10-236
Clinicaltrials.gov ID
NCT03238326
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-10-236
Trial Details
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Age
13 - 17 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Aug 2017 - Apr 2025
    Healthy Volunteers
    No
    • 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).
    • 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

    Study Summary

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

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Brexpiprazole
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    295
    Additional Study Details

    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.

    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).
    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

    Study Documents

    Study Protocol
    Available Languages: English
    DOWNLOAD DOCUMENT(S)
    Statistical Analysis Plan
    Available Languages: English
    DOWNLOAD DOCUMENT(S)

    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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