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Clinical Trial Summary

The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are currently on treatment with oral aripiprazole.


Clinical Trial Description

The purpose of this study is to evaluate the pharmacokinetics of aripiprazole in subjects with Bipolar 1 Disorder or Schizophrenia who have a history of suboptimal aderence and are currently on treatment with oral aripiprazole. This will be an open-label observational pilot trial to compare the PK profile of aripiprazole at Visit 1 of subjects who are receiving oral aripiprazole and who have the potential for suboptimal adherent behavior with their assigned medication.

Information obtained in the current trial will be used to inform the conduct of a randomized, open-label, parallel-group trial to assess between-group change from baseline adherence using PK sampling in subjects receiving oral aripiprazole with or without the MIND1 System (Protocol 316-13-211). ;


Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional


Related Conditions & MeSH terms


NCT number NCT02050854
Study type Observational
Source Otsuka Pharmaceutical Development & Commercialization, Inc.
Contact
Status Completed
Phase N/A
Start date December 2013
Completion date January 2014

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