- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Garden Grove, California, United States, 92845
- Research Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: D-Tect Patch
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.
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Oral placebo-embedded IEM tablet.
Oral aripiprazole-embedded IEM tablet.
Other Names:
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cohort 1: Positive Detection Accuracy (PDA) of D-Tect Patch
Time Frame: Day 1
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The PDA is calculated as the number of total positive detections by patch divided by the number of the total directly observed ingestions (DOIs).
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Day 1
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Cohort 1 and 2: Patch Detection Latency Period
Time Frame: Day 1
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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.
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Day 1
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Cohort 1 and 2: Ingestion Data Transfer Latency Period
Time Frame: Day 1
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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.
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Day 1
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Cohort 1 and 2: Total Detection Latency Period
Time Frame: Day 1
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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.
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Day 1
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
Time Frame: From signing of informed consent form to last participants final assessment (Up to Day 17)
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From signing of informed consent form to last participants final assessment (Up to Day 17)
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mood Disorders
- Schizophrenia Spectrum and Other Psychotic Disorders
- Depressive Disorder
- Schizophrenia
- Mental Disorders
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agonists
- Dopamine Agents
- Serotonin 5-HT1 Receptor Agonists
- Serotonin Receptor Agonists
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Dopamine D2 Receptor Antagonists
- Dopamine Antagonists
- Aripiprazole
Other Study ID Numbers
- 031-201-00521
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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