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

Study Identifier:
031-201-00521
ClinicalTrials.gov Identifier:
NCT06372210
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
Download document(s)
Statistical Analysis Plan
Available Language: English
Download document(s)

Study Details

Medical Condition
  • Mental disorder
  • Schizophrenia
  • Depression
  • Bipolar Disorder
Study Drug
  • Drug: Placebo IEM tablet
  • Drug: Abilify MyCite®
Date
Jun 2023 - Jul 2023
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18+ years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion 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.

Protocol Summary

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

Study Locations

Location
Status
Location
Research site
Garden Grove, California, United States, 92845
Status
N/A
© 2025 Otsuka America Pharmaceutical,
Inc All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion 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.

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