Schizophrenia Clinical Trial
Official title:
An Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia Who Have a History of Suboptimal Adherence and Are Currently on Treatment With Oral Aripiprazole
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.
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).
;
Observational Model: Cohort, Time Perspective: Cross-Sectional
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