Clinical trial NCT00151450: Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Anxiety
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-09
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.
Secondary outcomes:
Other outcomes:
Locations:
city: De Pinte
country: Belgium
facility: Pfizer Investigational Site
city: Gent
country: Belgium
facility: Pfizer Investigational Site
city: Ghent
country: Belgium
facility: Pfizer Investigational Site
city: Waregem
country: Belgium
facility: Pfizer Investigational Site
city: Kelowna
country: Canada
facility: Pfizer Investigational Site
state: British Columbia
city: Hamilton
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: Pfizer Investigational Site
state: Ontario
city: Gatineau
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Saint-Jean-Sur-Richelieu
country: Canada
facility: Pfizer Investigational Site
state: Quebec
city: Angouleme
country: France
facility: Pfizer Investigational Site
city: Arcachon
country: France
facility: Pfizer Investigational Site
city: Bully Les Mines
country: France
facility: Pfizer Investigational Site
city: Cherbourg
country: France
facility: Pfizer Investigational Site
city: Elancourt
country: France
facility: Pfizer Investigational Site
city: Orvault
country: France
facility: Pfizer Investigational Site
city: Rennes
country: France
facility: Pfizer Investigational Site
city: Saint-andre-de-cubzac
country: France
facility: Pfizer Investigational Site
city: Savigny Sur Orge
country: France
facility: Pfizer Investigational Site
city: Strasbourg
country: France
facility: Pfizer Investigational Site
city: Versailles
country: France
facility: Pfizer Investigational Site
city: Bray
country: Ireland
facility: Pfizer Investigational Site
state: County Wicklow
city: Vicenza
country: Italy
facility: Pfizer Investigational Site
state: Bassano DEL Grappa
city: Citta' Di Castello
country: Italy
facility: Pfizer Investigational Site
state: Perugia
city: Catania
country: Italy
facility: Pfizer Investigational Site
city: Sassari
country: Italy
facility: Pfizer Investigational Site
city: Wildervank
country: Netherlands
facility: Pfizer Investigational Site
state: GR
city: Hoogvliet
country: Netherlands
facility: Pfizer Investigational Site
city: Huizen
country: Netherlands
facility: Pfizer Investigational Site
city: Losser
country: Netherlands
facility: Pfizer Investigational Site
city: Musselkanaal
country: Netherlands
facility: Pfizer Investigational Site
city: Oude Pekela
country: Netherlands
facility: Pfizer Investigational Site
city: Langreo
country: Spain
facility: Pfizer Investigational Site
state: Asturias
city: VIC
country: Spain
facility: Pfizer Investigational Site
state: Barcelona
city: Alcala de Henares
country: Spain
facility: Pfizer Investigational Site
state: Madrid
city: Gandia
country: Spain
facility: Pfizer Investigational Site
state: Valencia
city: Barcelona
country: Spain
facility: Pfizer Investigational Site
city: Madrid
country: Spain
facility: Pfizer Investigational Site
city: Salamanca
country: Spain
facility: Pfizer Investigational Site
city: Zamora
country: Spain
facility: Pfizer Investigational Site
city: Göteborg
country: Sweden
facility: Pfizer Investigational Site
city: Linkoping
country: Sweden
facility: Pfizer Investigational Site
city: Lund
country: Sweden
facility: Pfizer Investigational Site
city: Malmö
country: Sweden
facility: Pfizer Investigational Site
city: Stockholm
country: Sweden
facility: Pfizer Investigational Site
city: Sundsvall
country: Sweden
facility: Pfizer Investigational Site
city: Trollhattan
country: Sweden
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.