Open-Label Observational Pilot Study to Evaluate the Pharmacokinetics of Aripiprazole in Subjects With Bipolar 1 Disorder or Schizophrenia

Completed

Conditions studied: Bipolar 1 Disorder, Schizophrenia, Mental Disorder, Nervous System Disorders

In brief

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.

Key facts

Study ID

NCT02050854

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

47

Starts

2013-12-01

Expected to finish

2014-01-01

Last updated by the study team

2014-01-31

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects 18 to 55 years of age (inclusive) at time of informed consent
• Subjects with a primary current Axis 1 disorder of bipolar 1 disorder or schizophrenia as defined by DSM-IV-TR criteria, who have been treated in the outpatient setting for at least 2 months before screening
• Subjects with a score of 1-7 on the Morisky 8-Item Medication Adherence Scale (MMAS-8)
• Subjects with bipolar 1 disorder who have a YMRS score of 10 to 25 (inclusive), or subjects with schizophrenia who have a PANSS score of 60 to 90 (inclusive)
• Subjects able to ingest oral medication
• Subjects currently prescribed oral aripiprazole for either bipolar 1 disorder or schizophrenia, and who have not had any changes in their Aripiprazole regimen or dose over the last 2 weeks
• Subjects who have an exacerbation of mood or psychotic symptoms when they are not receiving treatment or are noncompliant with treatment for their bipolar 1 disorder or schizophrenia
• For subjects enrolled with bipolar 1 disorder, the current bipolar episode is mixed or manic (the current must not be a depressive episode)

You may not qualify if…

• Subjects with a current Axis I (DSM-IV-TR) diagnosis other than bipolar 1 disorder or schizophrenia
• Subjects with a current Axis II (DSM-IV-TR) diagnosis
• Subjects not able to self-administer their medication
• Subjects who reside in or attend a facility where medication is administered to them
• Subjects who have a score of 0 or 8 on the Morisky 8-Item Medication Adherence Scale (MMAS-8)
• Subjects who currently meet DSM-IV-TR criteria for substance dependence
• Subjects with a history of inpatient hospitalization for any psychiatric reason within the past 2 months before screening
• Subjects who have received any investigational product within the last 30 days
• Subjects known to be allergic, intolerant, or unresponsive to prior treatment with Aripiprazole or other quinolinones
• Subjects who, per investigator's judgment, are acutely psychotic or manic and/or exhibit symptoms currently requiring hospitalization

Where it is running

• Study site — Garden Grove, California, United States
• Study site — Atlanta, Georgia, United States
• Study site — Decatur, Georgia, United States
• Study site — Rockville, Maryland, United States
• Study site — Bellevue, Washington, United States

Full record on ClinicalTrials.gov

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