Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder

The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder...

Date First Received: September 7, 2005

Last Updated: March 19, 2008

Verified by: Pfizer, March 2008

Clinical Trial Phase: Phase 3 | Start Date: March 2005

Overall Status: Completed

Estimated Enrollment: 390

Brief Summary

Official Title: “An 8-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled, Flexible Dose Study Of Pregabalin (300-600 Mg/Day) And Venlafaxine XR (75-225 Mg/Day) For The Acute Treatment Of DSM-IV Generalized Anxiety Disorder In Outpatients”

Condition Keyword(s):

The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

  • Drug: Pregabalin
  • Drug: Venlafaxine XR

Outcome Measures for this Clinical Trial

Primary Measures

  • Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • Male and female outpatients with diagnosis of generalized anxiety disorder.

Exclusion Criteria:

  • Any serious or uncontrolled medical condition.
  • Current diagnosis of depression, dysthymia, obsessive-compulsive disorder.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Pfizer

Overall Clinical Trial Officials and Contacts

Pfizer CT.gov Call Center Study Director Pfizer  

Additional Information

Information obtained from ClinicalTrials.gov on February 08, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00151450

Study ID Number: A0081012

ClinicalTrials.gov Identifier: NCT00151450

Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

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Link to ClinicalStudyResults.org Posting

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