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Trial record 1 of 1 for:    NCT00151450
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Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder

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ClinicalTrials.gov Identifier: NCT00151450
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : March 21, 2008
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 7, 2005
First Posted Date  ICMJE September 9, 2005
Last Update Posted Date March 21, 2008
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: October 11, 2006)
Evaluation of the efficacy of pregabalin and Venlafaxine XR in the treatment of generalized anxiety disorder.
Original Primary Outcome Measures  ICMJE
 (submitted: September 7, 2005)
Evaluation of the efficacy of pregabalin and comparative agent in the treatment of generalized anxiety disorder.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder
Official Title  ICMJE 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
Brief Summary The purpose of the study is to compare pregabalin to Venlafaxine XR and placebo in the treatment of generalized anxiety disorder.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Anxiety
Intervention  ICMJE
  • Drug: Pregabalin
  • Drug: Venlafaxine XR
Study Arms  ICMJE Not Provided
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: September 7, 2005)
390
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Canada,   France,   Ireland,   Italy,   Netherlands,   Spain,   Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00151450
Other Study ID Numbers  ICMJE A0081012
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP