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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02722967
Recruitment Status : Completed
First Posted : March 30, 2016
Results First Posted : May 23, 2018
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Development & Commercialization, Inc.

Tracking Information
First Submitted Date  ICMJE March 13, 2016
First Posted Date  ICMJE March 30, 2016
Results First Submitted Date  ICMJE March 15, 2018
Results First Posted Date  ICMJE May 23, 2018
Last Update Posted Date May 23, 2018
Study Start Date  ICMJE March 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 27, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: March 24, 2016)
Number of Inbound and Outbound Calls by help type [ Time Frame: 8 weeks ]
Functionality of integrated call center will be measured by Inbound and Outbound calls by help type
Change History Complete list of historical versions of study NCT02722967 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Major Depressive Disorder
  • Bipolar I Disorder
Intervention  ICMJE 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
Study Arms  ICMJE 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.
Intervention: Drug: Aripiprazole + IEM (Ingestible Event Marker)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2016)
49
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2016)
50
Actual Study Completion Date  ICMJE September 2016
Actual Primary Completion Date September 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02722967
Other Study ID Numbers  ICMJE 316-13-215
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Sponsor  ICMJE Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Tim Peters-Strickland, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.
PRS Account Otsuka Pharmaceutical Development & Commercialization, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP