Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder
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
1 other identifier
interventional
390
8 countries
45
Brief Summary
The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 anxiety
Started Mar 2005
45 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 7, 2005
CompletedFirst Posted
Study publicly available on registry
September 9, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedJanuary 22, 2021
March 1, 2008
September 7, 2005
January 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.
Interventions
Eligibility Criteria
You may qualify if:
- Male and female outpatients with diagnosis of generalized anxiety disorder.
You may not qualify if:
- Any serious or uncontrolled medical condition.
- Current diagnosis of depression, dysthymia, obsessive-compulsive disorder.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Pfizer Investigational Site
De Pinte, Belgium
Pfizer Investigational Site
Ghent, Belgium
Pfizer Investigational Site
Waregem, Belgium
Pfizer Investigational Site
Kelowna, British Columbia, Canada
Pfizer Investigational Site
Hamilton, Ontario, Canada
Pfizer Investigational Site
Ottawa, Ontario, Canada
Pfizer Investigational Site
Gatineau, Quebec, Canada
Pfizer Investigational Site
Saint-Jean-sur-Richelieu, Quebec, Canada
Pfizer Investigational Site
Angoulême, France
Pfizer Investigational Site
Arcachon, France
Pfizer Investigational Site
Bully-les-Mines, France
Pfizer Investigational Site
Cherbourg, France
Pfizer Investigational Site
Élancourt, France
Pfizer Investigational Site
Orvault, France
Pfizer Investigational Site
Rennes, France
Pfizer Investigational Site
Saint-André-de-Cubzac, France
Pfizer Investigational Site
Savigny-sur-Orge, France
Pfizer Investigational Site
Strasbourg, France
Pfizer Investigational Site
Versailles, France
Pfizer Investigational Site
Bray, County Wicklow, Ireland
Pfizer Investigational Site
Vicenza, Bassano DEL Grappa, Italy
Pfizer Investigational Site
Città di Castello, Perugia, Italy
Pfizer Investigational Site
Catania, Italy
Pfizer Investigational Site
Sassari, Italy
Pfizer Investigational Site
Wildervank, Provincie Groningen, Netherlands
Pfizer Investigational Site
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
Vic, Barcelona, Spain
Pfizer Investigational Site
Alcalá de Henares, Madrid, Spain
Pfizer Investigational Site
Langreo, Principality of Asturias, Spain
Pfizer Investigational Site
Gandia, Valencia, Spain
Pfizer Investigational Site
Barcelona, Spain
Pfizer Investigational Site
Madrid, Spain
Pfizer Investigational Site
Salamanca, Spain
Pfizer Investigational Site
Zamora, Spain
Pfizer Investigational Site
Gothenburg, Sweden
Pfizer Investigational Site
Linköping, Sweden
Pfizer Investigational Site
Lund, Sweden
Pfizer Investigational Site
Malmo, Sweden
Pfizer Investigational Site
Stockholm, Sweden
Pfizer Investigational Site
Sundsvall, Sweden
Pfizer Investigational Site
Trollhättan, Sweden
Related Publications (1)
Kasper S, Herman B, Nivoli G, Van Ameringen M, Petralia A, Mandel FS, Baldinetti F, Bandelow B. Efficacy of pregabalin and venlafaxine-XR in generalized anxiety disorder: results of a double-blind, placebo-controlled 8-week trial. Int Clin Psychopharmacol. 2009 Mar;24(2):87-96. doi: 10.1097/yic.0b013e32831d7980.
PMID: 21456104DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2005
First Posted
September 9, 2005
Study Start
March 1, 2005
Study Completion
November 1, 2006
Last Updated
January 22, 2021
Record last verified: 2008-03