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

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.

Completed

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Key information

Conditions

Schizophrenia Bipolar I Disorder Depressive Disorder Depressive Disorder, Major Major Depressive Disorder Mental Disorders Mood Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Granada Hills, California, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aripiprazole + IEM (Ingestible Event Marker)

Drug

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.

Other names: MIND1, Digital Medicine System

Primary outcomes

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.

Time frame: From baseline upto week 9
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

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study 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

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2016
First posted: Mar 30, 2016
Registry last updated: May 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed