A Trial in Adult Participants With Schizophrenia Treated Prospectively for 6‑months With Abilify MyCite®

Sponsor ID
031-201-00301
Clinicaltrials.gov ID
NCT03892889
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Terminated/Withdrawn
Sponsor ID
031-201-00301
Trial Details
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Age
18 - 65 Years
Therapeutic Area
  • Schizophrenia
    • Sex
    Female & Male
    Trial Dates
    Apr 2019 - Aug 2020
    Healthy Volunteers
    No
    • Participants must be willing and able to give written informed consent, adhere to trial procedures and able to read and understand English.
    • Male and female participants 18 to 65 years of age.
    • Participants must possess a smartphone and is familiar with its use and is willing to download and interact with the Abilify MyCite® app. Participants with a smartphone, that is not compatible with the Abilify MyCite® app will be offered a loaner phone for the trial period.
    • Clinical diagnosis of schizophrenia and able to ingest oral medication.
    • Positive and Negative Syndrome Scale (PANSS) total score between 60-90.
    • Participants currently prescribed oral atypical antipsychotic medication including aripiprazole or appropriate for aripiprazole treatment for 6 months or longer.
    • Participants are required to have had an inpatient hospitalization for schizophrenia within the last 48 months prior to entering the trial.
    • Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems.
    • Females who are breast-feeding and/or who are pregnant.
    • Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Abilify MyCite®.
    • Any participants who participated in another clinical trial within 30 days of enrollment.
    • Participants who are currently being treated with an LAI antipsychotic or have been treated with an LAI in the retrospective 6-month phase.
    • Participants with a current DSM-5 diagnosis other than schizophrenia.
    • Participants with a known allergy to adhesive tape or any pertinent components of the patch or aripiprazole tablet embedded with an IEM sensor.

    Study Summary

    To compare inpatient psychiatric hospitalization rates while participants are on oral standard-of-care antipsychotic treatment and later switched to Abilify MyCite®.

    Additional Study Details

    Phase
    Phase 3
    Study Drug
    N/A
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    277
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • * Participants must be willing and able to give written informed consent, adhere to trial procedures and able to read and understand English.
    • * Male and female participants 18 to 65 years of age.

    Exclusion Criteria

    • * Females who are breast-feeding and/or who are pregnant.
    • * Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Abilify MyCite®.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Participants must be willing and able to give written informed consent, adhere to trial procedures and able to read and understand English.
    • Male and female participants 18 to 65 years of age.
    • Participants must possess a smartphone and is familiar with its use and is willing to download and interact with the Abilify MyCite® app. Participants with a smartphone, that is not compatible with the Abilify MyCite® app will be offered a loaner phone for the trial period.
    • Clinical diagnosis of schizophrenia and able to ingest oral medication.
    • Positive and Negative Syndrome Scale (PANSS) total score between 60-90.
    • Participants currently prescribed oral atypical antipsychotic medication including aripiprazole or appropriate for aripiprazole treatment for 6 months or longer.
    • Participants are required to have had an inpatient hospitalization for schizophrenia within the last 48 months prior to entering the trial.
    • Skin on the anterior chest just above the lower edge of the rib cage that is free of any dermatological problems.
    Exclusion Criteria:
    • Females who are breast-feeding and/or who are pregnant.
    • Sexually active males or women of childbearing potential (WOCBP) who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose of Abilify MyCite®.
    • Any participants who participated in another clinical trial within 30 days of enrollment.
    • Participants who are currently being treated with an LAI antipsychotic or have been treated with an LAI in the retrospective 6-month phase.
    • Participants with a current DSM-5 diagnosis other than schizophrenia.
    • Participants with a known allergy to adhesive tape or any pertinent components of the patch or aripiprazole tablet embedded with an IEM sensor.

    Study Documents

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

    Locations

    Location
    Status
    Location
    Alea Research
    Phoenix, Arizona, United States, 85012
    Status
    N/A
    Location
    Woodland International Research Group
    Little Rock, Arkansas, United States, 72211
    Status
    N/A
    Location
    ADVANCED RESEARCH CENTER, Inc.
    Anaheim, California, United States, 92805
    Status
    N/A
    Location
    CITrials
    Bellflower, California, United States, 90706
    Status
    N/A
    Location
    Synexus
    Cerritos, California, United States, 90703
    Status
    N/A
    Location
    CMB Clinical Trials
    Colton, California, United States, 92324
    Status
    N/A
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