PK Effects of Bifeprunox & Valproate in Bipolar I

This study has been completed.
Sponsor:
Collaborators:
H. Lundbeck A/S
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00141505
First received: August 30, 2005
Last updated: September 6, 2007
Last verified: September 2007
  Purpose

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 Intervention Phase
Bipolar I Disorder
Drug: Bifeprunox
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:


Further study details as provided by Solvay Pharmaceuticals:

Study Start Date: February 2005
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00141505

Locations
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
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00141505     History of Changes
Other Study ID Numbers: S154.2.015
Study First Received: August 30, 2005
Last Updated: September 6, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Solvay Pharmaceuticals:
drug interaction
pharmacokinetics
valproate
bipolar

Additional relevant MeSH terms:
Valproic Acid
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on April 22, 2014