Schizophrenia Clinical Trial
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
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.
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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