PK Effects of Bifeprunox & Valproate in Bipolar I

Solvay

Status and phase: Completed; Phase 2

Conditions: Bipolar I Disorder

Treatments: Drug: Bifeprunox

Study type: Interventional

Funder types: Industry

Identifiers

NCT00141505

S154.2.015

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind