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

Otsuka

Status: Completed

Conditions: Major Depressive Disorder; Mental Disorder; Bipolar I Disorder; Schizophrenia

Treatments: Device: D-Tect Patch; Drug: Abilify MyCite®; Drug: Placebo IEM tablet

Study type: Interventional

Funder types: Industry

Identifiers

NCT06372210

031-201-00521

Details and patient eligibility

About

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

Full 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.

Enrollment: 54 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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54 participants in 1 patient group

D-Tect Patch

Experimental group

Description:

A D-Tect patch was applied by the clinical staff prior to each IEM tablet ingestion, and directly observed ingestions (DOIs), followed by ingestion of 15 placebo-embedded IEM tablets, 1 every 15 minutes in Cohort 1 on Day 1 and a single dose of Abilify MyCite® tablet in Cohort 2 on Day 1.

Treatment:

Drug: Placebo IEM tablet

Device: D-Tect Patch

Drug: Abilify MyCite®