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

• Register: ClinicalTrials.gov
• Last refreshed on: 1 February 2021
• Main ID: NCT00151450
• Date of registration: 07/09/2005
• Prospective Registration: No
• Primary sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
• Public title: Comparison of Pregabalin Versus Venlafaxine XR and Placebo in the Treatment of Generalized Anxiety Disorder
• Scientific 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
• Date of first enrolment: March 2005
• Target sample size: 390
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00151450
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double.
• Phase: Phase 3

Countries of recruitment

Belgium, Canada, France, Ireland, Italy, Netherlands, Spain, Sweden

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Anxiety

Intervention(s)

Drug: Venlafaxine XR

Drug: Pregabalin

Primary Outcome(s)

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

Secondary ID(s)

A0081012

Source(s) of Monetary Support

Please refer to primary and secondary sponsors