PK Effects of Bifeprunox & Valproate in Bipolar I

Solvay Pharmaceuticals

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Bipolar I Disorder

Interventions

BifeprunoxDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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.

Locations (1)

Site 1

Atlanta, Georgia, United States

Data from ClinicalTrials.gov

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