PK Effects of Bifeprunox & Valproate in Bipolar I

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00141505
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : January 16, 2015
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Bipolar I Disorder Drug: Bifeprunox Phase 2

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Placebo-controlled Study on the Pharmacokinetics,Pharmacodynamics, Safety and Tolerability of Concurrent Valproate and Bifeprunox Administration in Subjects With Bipolar I Disorder
Study Start Date : February 2005
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00141505

United States, Georgia
Site 1
Atlanta, Georgia, United States
Sponsors and Collaborators
Solvay Pharmaceuticals
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals Identifier: NCT00141505     History of Changes
Other Study ID Numbers: S154.2.015
First Posted: September 1, 2005    Key Record Dates
Last Update Posted: January 16, 2015
Last Verified: September 2007

Keywords provided by Solvay Pharmaceuticals:
drug interaction

Additional relevant MeSH terms:
Valproic Acid
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
GABA Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Antimanic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs