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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-26

Study Completion Date

2023-07-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DIMES - DIgital MEdicine Study for Adults With Schizophrenia, Bipolar I Disorder, or Major Depression Currently Using Aripiprazole

NCT03881449

Schizophrenia Major Depressive Disorder Bi-Polar Disorder +1 more

UNKNOWN PHASE4

A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder

NCT03854409

Schizophrenia Bipolar I Disorder

COMPLETED PHASE1

Safety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I Disorder

NCT00374920

Bipolar Disorder With Manic or Mixed Episodes

COMPLETED PHASE2

A Trial to Measure the Difference in All-cause Hospitalizations for Participants Who Are Using Abilify MyCite Versus Virtual Matched Controls in Adults With Schizophrenia, Bipolar 1 Disorder, and Major Depressive Disorder

NCT03643159

Schizophrenia Bipolar 1 Disorder Major Depressive Disorder

TERMINATED PHASE4

Real-world Lithium Intake

NCT07167563

Bipolar Disorder (BD)

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Disorder Schizophrenia Major Depressive Disorder Bipolar I Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Placebo IEM tablet

Intervention Type DRUG

Oral placebo-embedded IEM tablet.

Abilify MyCite®

Intervention Type DRUG

Oral aripiprazole-embedded IEM tablet.

D-Tect Patch

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Placebo IEM tablet

Oral placebo-embedded IEM tablet.

Intervention Type DRUG

Abilify MyCite®

Oral aripiprazole-embedded IEM tablet.

Intervention Type DRUG

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

OPC-14597 Digital

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes