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

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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.

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Major Depressive Disorder Bipolar I Disorder Drug: Aripiprazole + IEM (Ingestible Event Marker) Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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




Primary Outcome Measures :
  1. 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




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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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
Sponsors and Collaborators
Otsuka Pharmaceutical Development & Commercialization, Inc.
Investigators
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Study Director: Tim Peters-Strickland, M.D. Otsuka Pharmaceutical Development & Commercialization, Inc.

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Responsible Party: Otsuka Pharmaceutical Development & Commercialization, Inc.
ClinicalTrials.gov Identifier: NCT02722967     History of Changes
Other Study ID Numbers: 316-13-215
First Posted: March 30, 2016    Key Record Dates
Results First Posted: May 23, 2018
Last Update Posted: May 23, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Aripiprazole
Disease
Schizophrenia
Depressive Disorder
Depression
Depressive Disorder, Major
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Mood Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Serotonin 5-HT2 Receptor Antagonists
Serotonin Antagonists
Dopamine D2 Receptor Antagonists
Dopamine Antagonists