NCT06372210

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Mental Disorder
• Schizophrenia
• Major Depressive Disorder
• Bipolar I Disorder

Interventions

Type	Name	Description
DRUG	Placebo IEM tablet	Oral placebo-embedded IEM tablet.
DRUG	Abilify MyCite®	Oral aripiprazole-embedded IEM tablet.
DEVICE	D-Tect Patch	The D-Tect patch is a wearable sensor (WS) capable of detecting the ingestion of the IEM and measuring physiologic parameters. The WS automatically logs and stores the time when the IEM reaches the stomach and transmits the data to a smartphone.

Timeline

• Start date: 2023-06-26
• Primary completion: 2023-07-19
• Completion: 2023-07-19
• First posted: 2024-04-17
• Last updated: 2024-07-31
• Results posted: 2024-07-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study