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).
Study Type
OBSERVATIONAL
Enrollment
47
Unnamed facility
Garden Grove, California, United States
Unnamed facility
Atlanta, Georgia, United States
Unnamed facility
Decatur, Georgia, United States
Unnamed facility
Rockville, Maryland, United States
Unnamed facility
Mean log transformed-area under the plasma concentration-time curve (AUC) at Visit 1 for subjects receiving oral aripiprazole, compared to historical values
Time frame: Visit 1 (Day 1)
Potential relationships between a clinically accepted indicator of non-adherent behavior, the Morisky 8-item Medication Adherence scale (MMAS-8), and aripiprazole concentrations in subjects
Time frame: Visit 1 (Day 1) to End of Study
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