N/A
Completed N=54
A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion
Source: ClinicalTrials.gov NCT06372210 ↗Enrolled (actual)
54
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch — 100 percentage of detections
Summary
The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch |
100 | — |
| PRIMARY Cohort 1 and 2: Patch Detection Latency Period |
53.0; 312.0 | — |
| PRIMARY Cohort 1 and 2: Ingestion Data Transfer Latency Period |
17.0; 17.0 | — |
| PRIMARY Cohort 1 and 2: Total Detection Latency Period |
73.0; 351.0 | — |
| SECONDARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation |
7; 3; 5; 3; 0; 0 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT06372210). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.