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

NCT06372210 | Completed Results FDA Device

• 1 other identifier: 031-201-00521
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

D-Tect patch

Outcome Measures

Primary Outcomes (4)

• 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 DOIs. PDA was estimated by Clopper-Pearson method.

  At Day 1

• Cohort 1 and 2: Patch Detection Latency Period

  The patch detection latency period is defined as the time between the ingestion of the tablet and the detection of the tablet ingestion by the patch. Kaplan Meier estimation was used to measure the patch detection latency period.

  At Day 1

• 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 tablet ingestion by the patch and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the ingestion data transfer latency period.

  At Day 1

• Cohort 1 and 2: Total Detection Latency Period

  The total detection latency is measured as the total time between the ingestion of the tablet and the display of ingestion data on the mobile device. Kaplan Meier estimation was used to measure the total detection the latency period.

  At Day 1

Secondary Outcomes (1)

• Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Device-related TEAEs, Serious TEAEs (SAEs), TEAEs Leading to Study Discontinuation

  From Day 1 up to follow-up (up to Day 10)

Study Arms (1)

D-Tect Patch

EXPERIMENTAL

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.

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

Interventions

Placebo IEM tablet DRUG

Oral placebo-embedded IEM tablet.

D-Tect Patch

Abilify MyCite® DRUG

Oral aripiprazole-embedded IEM tablet.

Also known as: OPC-14597 Digital

D-Tect Patch

D-Tect Patch DEVICE

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.

D-Tect Patch

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

Research site

Garden Grove, California, 92845, United States

Location

MeSH Terms

Conditions

Mental Disorders; Schizophrenia; Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Depressive Disorder; Mood Disorders

Results Point of Contact

• Title: Global Clinical Development
• Organization: Otsuka Pharmaceutical Development & Commercialization, Inc.

clinicaltransparency@otsuka-us.com

1-609-524-6788

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: April 17, 2024
• Study Start: June 26, 2023
• Primary Completion: July 19, 2023
• Study Completion: July 19, 2023
• Last Updated: July 31, 2024
• Results First Posted: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• Access Criteria: Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com

Locations

US (1)