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

NCT ID: NCT00151450

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

390 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2006-11-30

Brief Summary

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

Detailed Description

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Conditions

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Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Pregabalin

Intervention Type DRUG

Venlafaxine XR

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

De Pinte, , Belgium

Site Status

Pfizer Investigational Site

Ghent, , Belgium

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Waregem, , Belgium

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Kelowna, British Columbia, Canada

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Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Gatineau, Quebec, Canada

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Saint-Jean-sur-Richelieu, Quebec, Canada

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Angoulême, , France

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Arcachon, , France

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Bully-les-Mines, , France

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Cherbourg, , France

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Élancourt, , France

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Orvault, , France

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Rennes, , France

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Saint-André-de-Cubzac, , France

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Savigny-sur-Orge, , France

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Strasbourg, , France

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Versailles, , France

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Bray, County Wicklow, Ireland

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Vicenza, Bassano DEL Grappa, Italy

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Città di Castello, Perugia, Italy

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Catania, , Italy

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Sassari, , Italy

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Wildervank, Provincie Groningen, Netherlands

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Hoogvliet, , Netherlands

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Huizen, , Netherlands

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Losser, , Netherlands

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Musselkanaal, , Netherlands

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Oude Pekela, , Netherlands

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Vic, Barcelona, Spain

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Alcalá de Henares, Madrid, Spain

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Langreo, Principality of Asturias, Spain

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Gandia, Valencia, Spain

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Barcelona, , Spain

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Madrid, , Spain

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Salamanca, , Spain

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Zamora, , Spain

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Gothenburg, , Sweden

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Linköping, , Sweden

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Lund, , Sweden

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Malmo, , Sweden

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Stockholm, , Sweden

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Sundsvall, , Sweden

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Trollhättan, , Sweden

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Countries

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Belgium Canada France Ireland Italy Netherlands Spain Sweden

References

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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.

Reference Type DERIVED
PMID: 21456104 (View on PubMed)

Related Links

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Other Identifiers

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A0081012

Identifier Type: -

Identifier Source: org_study_id

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