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

NCT00151450

Last updated date
Study Location
Pfizer Investigational Site
De Pinte, , , Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anxiety
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and female outpatients with diagnosis of generalized anxiety disorder.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Any serious or uncontrolled medical condition.


- Current diagnosis of depression, dysthymia, obsessive-compulsive disorder.

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AnxietyComparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder
NCT00151450
  1. De Pinte,
  2. Gent,
  3. Ghent,
  4. Waregem,
  5. Kelowna, British Columbia
  6. Hamilton, Ontario
  7. Ottawa, Ontario
  8. Gatineau, Quebec
  9. Saint-Jean-Sur-Richelieu, Quebec
  10. Angouleme,
  11. Arcachon,
  12. Bully Les Mines,
  13. Cherbourg,
  14. Elancourt,
  15. Orvault,
  16. Rennes,
  17. Saint-andre-de-cubzac,
  18. Savigny Sur Orge,
  19. Strasbourg,
  20. Versailles,
  21. Bray, County Wicklow
  22. Vicenza, Bassano Del Grappa
  23. Citta' Di Castello, Perugia
  24. Catania,
  25. Sassari,
  26. Wildervank, GR
  27. Hoogvliet,
  28. Huizen,
  29. Losser,
  30. Musselkanaal,
  31. Oude Pekela,
  32. Langreo, Asturias
  33. VIC, Barcelona
  34. Alcala de Henares, Madrid
  35. Gandia, Valencia
  36. Barcelona,
  37. Madrid,
  38. Salamanca,
  39. Zamora,
  40. Göteborg,
  41. Linkoping,
  42. Lund,
  43. Malmö,
  44. Stockholm,
  45. Sundsvall,
  46. Trollhattan,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 CenterPfizer
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