A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion

Sponsor ID
031-201-00521
Clinicaltrials.gov ID
NCT06372210
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
031-201-00521
Trial Details
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Age
18+ years
Therapeutic Area
  • Mental disorder
  • Schizophrenia
  • Depression
  • Bipolar Disorder
    • Sex
    Female & Male
    Trial Dates
    Jun 2023 - Jul 2023
    Healthy Volunteers
    Yes
    • Inclusion Criteria for Cohort 1:
    • In good general health or medically stable.
    • Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
    • The participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant.
    • Inclusion Criteria for Cohort 2:
    • In good general health or medically stable.
    • Has confirmed diagnosis of schizophrenia, major depressive disorder, or bipolar I disorder per Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and currently prescribed and taking aripiprazole.
    • Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
    • Participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant
    • Exclusion Criteria for Cohort 1 and 2:
    • Any medical condition, treatment, or symptoms that, in the judgment of the trial clinician, could place the participant at more than the minimal risk from involvement in the testing.
    • Hospitalization, emergency room visit, surgery or new medical treatment within 30 days before testing begins or planned during testing.
    • Difficulty with or inability to swallow tablets.
    • Active skin infection or active dermatitis, or history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis).
    • The investigator will determine if any participant should be excluded from the trial based on history of, or current, alcohol abuse, drug abuse or use of illegal drugs (e.g., amphetamines or heroin).
    • Allergy to adhesive bandages/tapes (e.g., Band-Aids®) or latex.
    • Positive urine pregnancy test at screening visit (dipstick).
    • Participant is taking any concomitant medication that places the participant at a greater risk for skin reactions or skin sensitivity.

    Study Summary

    The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.

    Additional Study Details

    Phase
    N/A
    Study Drug
    Drug: Placebo IEM tablet
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    54
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Inclusion Criteria for Cohort 1:
    • * In good general health or medically stable.

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • Inclusion Criteria for Cohort 1:
    • In good general health or medically stable.
    • Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
    • The participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant.
    • Inclusion Criteria for Cohort 2:
    • In good general health or medically stable.
    • Has confirmed diagnosis of schizophrenia, major depressive disorder, or bipolar I disorder per Diagnostic and Statistical Manual of Mental Disorders - 5th Edition (DSM-5) criteria and currently prescribed and taking aripiprazole.
    • Is able and willing to participate in, and adhere to, all testing procedures, both onsite and offsite, for the entire testing.
    • Participant has access to a telephone for communicating with the trial personnel and for trial personnel to contact the participant
    • Exclusion Criteria for Cohort 1 and 2:
    • Any medical condition, treatment, or symptoms that, in the judgment of the trial clinician, could place the participant at more than the minimal risk from involvement in the testing.
    • Hospitalization, emergency room visit, surgery or new medical treatment within 30 days before testing begins or planned during testing.
    • Difficulty with or inability to swallow tablets.
    • Active skin infection or active dermatitis, or history of chronic inflammatory skin condition including psoriasis and chronic dermatitis (except atopic dermatitis).
    • The investigator will determine if any participant should be excluded from the trial based on history of, or current, alcohol abuse, drug abuse or use of illegal drugs (e.g., amphetamines or heroin).
    • Allergy to adhesive bandages/tapes (e.g., Band-Aids®) or latex.
    • Positive urine pregnancy test at screening visit (dipstick).
    • Participant is taking any concomitant medication that places the participant at a greater risk for skin reactions or skin sensitivity.

    Study Documents

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

    Locations

    Location
    Status
    Location
    Research site
    Garden Grove, California, United States, 92845
    Status
    N/A

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