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

This study has been completed.
Information provided by:
Pfizer Identifier:
First received: September 7, 2005
Last updated: March 19, 2008
Last verified: March 2008
The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.

Condition Intervention Phase
Drug: Pregabalin
Drug: Venlafaxine XR
Phase 3

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:

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

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

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
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Please refer to this study by its identifier: NCT00151450

  Show 46 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00151450     History of Changes
Other Study ID Numbers: A0081012 
Study First Received: September 7, 2005
Last Updated: March 19, 2008
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Venlafaxine Hydrochloride
Anti-Anxiety Agents
Antidepressive Agents
Antidepressive Agents, Second-Generation
Calcium Channel Blockers
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin and Noradrenaline Reuptake Inhibitors
Tranquilizing Agents processed this record on May 25, 2016