A Trial to Assess a Wearable Patch's Functioning to Detect Medication Ingestion
NCT06372210 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54
Last updated 2024-07-31
Summary
The primary purpose of the study is to evaluate the positive detection accuracy (PDA) and detection latency measures of the D-Tect patch.
Conditions
- Mental Disorder
- Schizophrenia
- Major Depressive Disorder
- Bipolar I Disorder
Interventions
- 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.
Sponsors & Collaborators
-
Otsuka Pharmaceutical Development & Commercialization, Inc.
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-06-26
- Primary Completion
- 2023-07-19
- Completion
- 2023-07-19
- FDA Device
- Yes
Countries
- United States
Study Locations
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