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NCT00141505 Clinical Trial

PK Effects of Bifeprunox & Valproate in Bipolar I

Bipolar I Disorder Clinical Trial

Official title:
Placebo-controlled Study on the Pharmacokinetics,Pharmacodynamics, Safety and Tolerability of Concurrent Valproate and Bifeprunox Administration in Subjects With Bipolar I Disorder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00141505
Other study ID # S154.2.015
Secondary ID
Status Completed
Phase Phase 2
First received August 30, 2005
Last updated January 15, 2015
Start date February 2005
Est. completion date December 2006

Study information
Verified date September 2007
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Bifeprunox

Locations
Country Name City State
United States Site 1 Atlanta Georgia

Sponsors (3)
Lead Sponsor Collaborator
Solvay Pharmaceuticals H. Lundbeck A/S, Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

United States, 

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