PK Effects of Bifeprunox & Valproate in Bipolar I

Completed · Phase 2

Conditions studied: Bipolar I Disorder

In brief

The study is to evaluate the effect of bifeprunox on the pharmacokinetics of valproate in subjects with Bipolar I Disorder after multiple dose administration.

Key facts

Study ID

NCT00141505

Run by

Solvay Pharmaceuticals

Starts

2005-02-01

Expected to finish

2006-12-01

Last updated by the study team

2015-01-16

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females
• 18-65 years old
• meeting DSM-IV criteria for Bipolar I Disorder, either manic or mixed episodes, with or without psychotic features

You may not qualify if…

• subjects who are acutely manic, acutely depressed, psychotic or subjects with a current Axis I primary psychiatric diagnosis other than Bipolar I Disorder based on DSM-IV TR criteria.

Where it is running

• Site 1 — Atlanta, Georgia, United States

Full record on ClinicalTrials.gov

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