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

January 20, 2021 updated by: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

390

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • De Pinte, Belgium
        • Pfizer Investigational Site
      • Gent, Belgium
        • Pfizer Investigational Site
      • Ghent, Belgium
        • Pfizer Investigational Site
      • Waregem, Belgium
        • Pfizer Investigational Site
  • Canada
    • British Columbia
      • Kelowna, British Columbia, Canada
        • Pfizer Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada
        • Pfizer Investigational Site
      • Ottawa, Ontario, Canada
        • Pfizer Investigational Site
    • Quebec
      • Gatineau, Quebec, Canada
        • Pfizer Investigational Site
      • Saint-Jean-Sur-Richelieu, Quebec, Canada
        • Pfizer Investigational Site
  • France
      • Angouleme, France
        • Pfizer Investigational Site
      • Arcachon, France
        • Pfizer Investigational Site
      • Bully Les Mines, France
        • Pfizer Investigational Site
      • Cherbourg, France
        • Pfizer Investigational Site
      • Elancourt, France
        • Pfizer Investigational Site
      • Orvault, France
        • Pfizer Investigational Site
      • Rennes, France
        • Pfizer Investigational Site
      • Saint-andre-de-cubzac, France
        • Pfizer Investigational Site
      • Savigny Sur Orge, France
        • Pfizer Investigational Site
      • Strasbourg, France
        • Pfizer Investigational Site
      • Versailles, France
        • Pfizer Investigational Site
  • Ireland
    • County Wicklow
      • Bray, County Wicklow, Ireland
        • Pfizer Investigational Site
  • Italy
      • Catania, Italy
        • Pfizer Investigational Site
      • Sassari, Italy
        • Pfizer Investigational Site
    • Bassano DEL Grappa
      • Vicenza, Bassano DEL Grappa, Italy
        • Pfizer Investigational Site
    • Perugia
      • Citta' Di Castello, Perugia, Italy
        • Pfizer Investigational Site
  • Netherlands
      • Hoogvliet, Netherlands
        • Pfizer Investigational Site
      • Huizen, Netherlands
        • Pfizer Investigational Site
      • Losser, Netherlands
        • Pfizer Investigational Site
      • Musselkanaal, Netherlands
        • Pfizer Investigational Site
      • Oude Pekela, Netherlands
        • Pfizer Investigational Site
    • GR
      • Wildervank, GR, Netherlands
        • Pfizer Investigational Site
  • Spain
      • Barcelona, Spain
        • Pfizer Investigational Site
      • Madrid, Spain
        • Pfizer Investigational Site
      • Salamanca, Spain
        • Pfizer Investigational Site
      • Zamora, Spain
        • Pfizer Investigational Site
    • Asturias
      • Langreo, Asturias, Spain
        • Pfizer Investigational Site
    • Barcelona
      • VIC, Barcelona, Spain
        • Pfizer Investigational Site
    • Madrid
      • Alcala de Henares, Madrid, Spain
        • Pfizer Investigational Site
    • Valencia
      • Gandia, Valencia, Spain
        • Pfizer Investigational Site
  • Sweden
      • Göteborg, Sweden
        • Pfizer Investigational Site
      • Linkoping, Sweden
        • Pfizer Investigational Site
      • Lund, Sweden
        • Pfizer Investigational Site
      • Malmö, Sweden
        • Pfizer Investigational Site
      • Stockholm, Sweden
        • Pfizer Investigational Site
      • Sundsvall, Sweden
        • Pfizer Investigational Site
      • Trollhattan, Sweden
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Study Completion (Actual)

November 1, 2006

Study Registration Dates

First Submitted

September 7, 2005

First Submitted That Met QC Criteria

September 7, 2005

First Posted (Estimate)

September 9, 2005

Study Record Updates

Last Update Posted (Actual)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 20, 2021

Last Verified

March 1, 2008

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0081012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on Pregabalin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe