Back to resultsExploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
Primary Purpose
Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aripiprazole + IEM (Ingestible Event Marker)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aripiprazole + IEM
Arm Description
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02722967
First Posted
March 13, 2016
Last Updated
April 27, 2018
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02722967
Brief Title
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Major Depressive Disorder, Bipolar I Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aripiprazole + IEM
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Aripiprazole + IEM (Ingestible Event Marker)
Other Intervention Name(s)
MIND1, Digital Medicine System
Intervention Description
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.
Primary Outcome Measure Information:
Title
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.
Description
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
Time Frame
From baseline upto week 9
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tim Peters-Strickland, M.D.
Organizational Affiliation
Otsuka Pharmaceutical Development & Commercialization, Inc.
Official's Role
Study Director
Facility Information:
City
Granada Hills
State/Province
California
ZIP/Postal Code
91344
Country
United States
City
Rochester
State/Province
New York
ZIP/Postal Code
14603
Country
United States
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27714
Country
United States
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Exploratory Trial to Assess the Functionality of an Integrated Call Center for the Digital Medicine System
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