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A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Pregabalin in Subjects With Generalized Anxiety Disorder (GAD) Switching From Benzodiazepine Therapy.
GAD subjects maintained on a stable dose of alprazolam for at least four weeks who meet eligibility criteria will be randomized to receive pregabalin vs matching placebo while simultaneously tapering off of alprazolam over 6 weeks. Subjects return weekly for assessment of safety/tolerability of pregabalin vs placebo as well as for assessment of anxiety and benzodiazepine withdrawal symptoms. Subjects successfully able to discontinue alprazolam, will continue 6 weeks of treatment with pregabalin vs placebo (free of benzodiazepine use). The efficacy and safety of pregabalin vs placebo for anxiety symptoms and ability to discontinue/remain free of alprazolam will be compared among pregabalin and placebo treated groups. Hypothesis is that a greater proportion of subjects will be successful in discontinuing and remaining free from benzodiazepines who were treated with pregabalin as compared to subjects treated with placebo.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
Pfizer Investigational Site
San Pedro, Provincia de San José, Costa Rica
Pfizer Investigational Site
Pilsen, Czechia
Pfizer Investigational Site
Prague, Czechia
Pfizer Investigational Site
Prague, Czechia
Pfizer Investigational Site
Prague, Czechia
Pfizer Investigational Site
Praha-Bubenec, Czechia
Pfizer Investigational Site
Paris, Cedex 12, France
Pfizer Investigational Site
Arcachon, France
Pfizer Investigational Site
Caen, France
Pfizer Investigational Site
Élancourt, France
Start Date
September 1, 2006
Primary Completion Date
August 1, 2008
Completion Date
August 1, 2008
Last Updated
February 9, 2021
108
ACTUAL participants
Pregabalin
DRUG
Placebo
DRUG
Lead Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
NCT07429578
NCT06661460
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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