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

Schizophrenia Clinical Trial

Official title:
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

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01981811
Study type Interventional
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status Withdrawn
Phase Phase 2
Start date March 2014
Completion date December 2014
View Details
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