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

Sponsor ID
331-10-234
Clinicaltrials.gov ID
NCT03198078
EudraCT ID
2017-001447-12
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
331-10-234
Trial Details
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Age
13 - 17 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Jun 2017 - Apr 2023
    Healthy Volunteers
    No
    • 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
    • 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

    Study Summary

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

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    Drug: Brexpiprazole (OPC-34712)
    Type
    Interventional
    Masking
    Quadruple
    Estimated Enrollment
    316
    Additional Study Details

    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
    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

    Study Documents

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

    Locations

    Location
    Status
    Location
    For additional information regarding sites, contact 844-687-8522
    Oklahoma City, Oklahoma, United States, 73116
    Status
    N/A

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