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
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Major Depressive Disorder Bipolar I Disorder||Drug: Aripiprazole + IEM (Ingestible Event Marker)||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||March 2016|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722967
|United States, California|
|Granada Hills, California, United States, 91344|
|United States, New York|
|Rochester, New York, United States, 14603|
|United States, North Carolina|
|Durham, North Carolina, United States, 27714|
|United States, Virginia|
|Richmond, Virginia, United States, 23230|
|Study Director:||Tim Peters-Strickland, M.D.||Otsuka Pharmaceutical Development & Commercialization, Inc.|