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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06372210
• Other study ID #: 031-201-00521
• Status: Completed
• Phase: N/A
• Start date: June 26, 2023
• Est. completion date: July 19, 2023

Study information

• Verified date: April 2024
• Source: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: July 19, 2023
• Est. primary completion date: July 19, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• Placebo IEM tablet
Oral placebo-embedded IEM tablet.
• 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.

Locations

Country	Name	City	State
United States	Research site	Garden Grove	California

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Development & Commercialization, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch	The PDA is calculated as the number of total positive detections by patch divided by the number of the total directly observed ingestions (DOIs).	Day 1
Primary	Cohort 1 and 2: Patch Detection Latency Period	The patch detection latency period is defined as the time between the ingestion of the IEM tablet and the detection of the IEM ingestion by the patch.	Day 1
Primary	Cohort 1 and 2: Ingestion Data Transfer Latency Period	The ingestion data transfer latency period is measured as the time between the detection of the IEM ingestion by the patch and the display of ingestion data on the mobile device.	Day 1
Primary	Cohort 1 and 2: Total Detection Latency Period	The total detection latency is measured as the time between the ingestion of the IEM tablet and the display of ingestion data on the mobile device.	Day 1
Secondary	Number of Participants With Adverse Events (AEs) Graded By Severity, Device-related AEs, Serious AEs (SAEs), AEs Leading to Trial Discontinuation, and Unanticipated Adverse device Effects		From signing of informed consent form to last participants final assessment (Up to Day 17)