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

This study has been completed.

First Received on September 7, 2005. Last Updated on March 19, 2008 History of Changes

Sponsor:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00151450

Purpose

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

Condition	Intervention	Phase
Anxiety	Drug: Pregabalin Drug: Venlafaxine XR	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

Drug Information available for: Venlafaxine Venlafaxine hydrochloride Pregabalin

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:

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

Estimated Enrollment:	390
Study Start Date:	March 2005
Study Completion Date:	November 2006

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151450

Show 46 Study Locations

Sponsors and Collaborators

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

ClinicalTrials.gov Identifier:	NCT00151450 History of Changes
Other Study ID Numbers:	A0081012
Study First Received:	September 7, 2005
Last Updated:	March 19, 2008
Health Authority:	Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders
Venlafaxine
Pregabalin
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents

Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 09, 2012