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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00151450
First received: September 7, 2005
Last updated: March 19, 2008
Last verified: March 2008
  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 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
  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:
No publications provided by Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: Federal Agency for Medicines and Health Products, FAMHP

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 April 17, 2014