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OpenTrials
Completed

NCT Number: NCT00141505

PK Effects of Bifeprunox & Valproate in Bipolar I

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

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Key information

Conditions

Bipolar I Disorder

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Site 1

Atlanta, Georgia, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Bifeprunox

Drug

Sponsors and collaborators

Lead sponsor

Solvay Pharmaceuticals

Industry

Collaborators

  • H. Lundbeck A/S
  • Wyeth is now a wholly owned subsidiary of Pfizer

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Sep 1, 2005
Registry last updated
Jan 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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