Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System

Study Overview
=================
Brief Summary
-----------------
This study will assess the helpfulness of the integrated call center in optimizing use of the Digital Medicine System in adult subjects with Schizophrenia, Major Depressive Disorder, or Bipolar Disorder taking oral aripiprazole.

Detailed Description
-----------------
The Digital Medicine System includes a drug-device combination of aripiprazole + an ingestible event marker (IEM), a wearable sensor (skin patch), and application software to convey the level of activity and rest, and to mark events through the act of ingestion. Physician and self-report are the most commonly used to assess medication compliance yet studies have consistently found that healthcare providers' subjective judgments of medication compliance are often inaccurate, with a tendency for practitioners to overestimate subject adherence. The sponsor's intent is to develop a system that will benefit future subjects by providing the ability to measure their medication-taking behavior in an objective manner and being able to monitor several physiologic parameters.

Official Title
-----------------
A Multicenter, 8-week, Open-label, Single-Arm Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System by Adult Subjects With Schizophrenia, Major Depressive Disorder, or Bipolar 1 Treated With Oral Aripiprazole

Conditions
-----------------
Schizophrenia, Major Depressive Disorder, Bipolar I Disorder

Intervention / Treatment
-----------------
* Drug: Aripiprazole + IEM (Ingestible Event Marker)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of Schizophrenia (SCH), Major Depressive Disorder (MDD), or Bipolar 1 Disorder (BP1), per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) Must be able to swallow tablets Currently taking a stable daily dose of oral aripiprazole Must have capacity to utilize the technology Skin in area of patch application must be free of any skin disorders or dermatological problems Exclusion Criteria: Subjects using long acting injectable antipsychotic medications Subjects likely to be incapable of using the Digital Medicine System even with assistance Subjects who present serious risk of suicide History of epilepsy or seizures History of hypersensitivity to antipsychotic agents, adhesive tape or any component of the sensor skin patch or ingestible event marker Current history of substance use disorder meeting DSM-5 criteria Subject with unstable mood, acute psychosis or exhibiting symptoms requiring hospitalization

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aripiprazole + IEM<br>Subjects will receive an intervention consisting of a drug-device combination that consists of an aripiprazole tablet with a tiny sensor embedded within it referred to as an Ingestible Event Marker (IEM) . They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole(2, 5, 10, 15, 20, or 30 mg) + IEM once daily for the 8-week assessment period for this trial. | Drug: Aripiprazole + IEM (Ingestible Event Marker)<br>* Oral aripiprazole (2, 5, 10, 15, 20, or 30 mg) with an ingestible event marker in a single daily dose for duration of the trial.<br>* Other names: Digital Medicine System;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the Functionality of an Integrated Call Center for DMS by Adult Subjects With SCH, MDD, or BP1 Who Were Treated With Oral Aripiprazole. | The primary outcome was assessed as the establishment of a functional and operational integrated call center with coordinated feedback to the subject and investigative site to optimize the use of DMS as measured by: Inbound calls (ie, calls from the subject to the integrated call center) by help type; Outbound calls (ie, calls from the integrated call center to the subject) by help type. The number presented in the table is the number of subjects in trial who made (inbound) or received (outbound) calls | From baseline upto week 9 |