The purpose of this study is to evaluate adherence to treatment with, and safety and tolerability of, the medical information device #1 (MIND1) system in subjects with Schizophrenia or Bipolar I Disorder who are currently treated with oral aripiprazole.
Poor adherence to medication is a well-recognized problem in psychiatric patients and is a barrier to achieving optimal health. The MIND1 System is being developed to objectively and precisely monitor and measure real-time medication adherence; and to potentially enhance adherence. The MIND1 System includes oral aripiprazole with an embedded ingestible event marker (IEM), a Wearable Sensor, and a computerized device and accessories. This is a trial designed to evaluate adherence to treatment with, and safety and tolerability of, the medical information device #1 (MIND1) system in subjects with schizophrenia or bipolar I disorder. This 12-week, single-arm trial will include male and female subjects 18 to 65years (inclusive) with a current diagnosis of schizophrenia or bipolar I disorder who are currently treated with oral aripiprazole.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Unnamed facility
Cerritos, California, United States
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Garden Grove, California, United States
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Long Beach, California, United States
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Medication adherence, as defined by the number of IEM detections reported by the MIND1 System divided by the medication doses prescribed.
Time frame: Baseline to Week 12
Compliance, defined as the ratio of individual model-predicted exposure (AUC) at Week 12 following administration of oral aripiprazole using the MIND1 System versus the expected exposure
Time frame: Week 12
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National City, California, United States
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Oceanside, California, United States
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San Diego, California, United States
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Washington D.C., District of Columbia, United States
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Atlanta, Georgia, United States
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St Louis, Missouri, United States
Unnamed facility
Marlton, New Jersey, United States
...and 2 more locations