Status:
COMPLETED
PK Effects of Bifeprunox & Valproate in Bipolar I
Lead Sponsor:
Solvay Pharmaceuticals
Collaborating Sponsors:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Bipolar I Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00141505
Start Date
February 1 2005
End Date
December 1 2006
Last Update
January 16 2015
Active Locations (1)
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1
Site 1
Atlanta, Georgia, United States