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.

Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder

Schizophrenia

Mental Disorder

Neurological Disorder

Nervous System Diseases

Bipolar 1 Disorder

Bipolar Disorder

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.

Abilify MyCite - Digital Medicine System

aripiprazole (OPC-14597)

A Single-arm Study 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

All subjects will continue to receive their previously prescribed dose of aripiprazole (10 mg, 15 mg, 20 mg, or 30 mg) through the trial. Subjects will discontinue dosing of the conventional oral aripiprazole tablet and will begin taking MIND1 (aripiprazole embedded with an Ingestible Event Marker) tablet once-daily for 12 weeks.

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.

Trial at a glance

Adherence to Treatment, Safety and Tolerability Study of the Medical Information Device #1 (MIND1) in Subjects With Schizophrenia or Bipolar I Disorder

CT.gov ID:

Summary

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