Clinical trial NCT06372210: A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion
Official title: An Open-label, Prospective Trial Assessing Positive Detection Accuracy and Detection Latency Measures of the Miniature Ingestible Event Marker Tablet Using the D-Tect Patch in Healthy Subjects and Assessing Detection Latency Measures Using the D-Tect Patch in Subjects With Serious Mental Illness Taking Abilify MyCite Tablet
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mental Disorder
Schizophrenia
Major Depressive Disorder
Bipolar I Disorder
Keywords: D-Tect patch
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
First posted: 2024-04-17
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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

Detailed description: This is an open-label study to determine the accuracy of ingestible event marker (IEM) detection and detection latency of the D-Tect patch by completing a series of patch applications and IEM ingestions in the clinic.

The participants were enrolled in two cohorts within this study- Cohort 1: healthy participants received the placebo-embedded IEM tablets, Cohort 2: participants with serious mental illness (SMI) i.e schizophrenia, major depressive disorder, or bipolar I disorder received Abilify MyCite® tablets (aripiprazole-embedded IEM tablets).

This single-center trial was conducted in the United States. The overall time to participate in this study is up to approximately 17 days.

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.

Primary outcomes:
measure: Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch
timeFrame: At Day 1
measure: Cohort 1 and 2: Patch Detection Latency Period
timeFrame: At Day 1
measure: Cohort 1 and 2: Ingestion Data Transfer Latency Period
timeFrame: At Day 1
measure: Cohort 1 and 2: Total Detection Latency Period
timeFrame: At Day 1
Secondary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation
timeFrame: From Day 1 up to follow-up (up to Day 10)
Other outcomes:
Locations:
city: Garden Grove
country: United States
facility: Research site
state: California
Study officials:
References: