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

April 27, 2018 updated by: Otsuka Pharmaceutical Development & Commercialization, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Granada Hills, California, United States, 91344
    • New York
      • Rochester, New York, United States, 14603
    • North Carolina
      • Durham, North Carolina, United States, 27714
    • Virginia
      • Richmond, Virginia, United States, 23230

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Aripiprazole + IEM
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)
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

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.
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:

  1. Inbound calls (ie, calls from the subject to the integrated call center) by help type;
  2. 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Investigators

  • Study Director: Tim Peters-Strickland, M.D., Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 13, 2016

First Submitted That Met QC Criteria

March 24, 2016

First Posted (Estimate)

March 30, 2016

Study Record Updates

Last Update Posted (Actual)

May 23, 2018

Last Update Submitted That Met QC Criteria

April 27, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 316-13-215

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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