NCT00413010

Pregabalin in the Treatment of Patients With Generalized Anxiety Disorder (GAD).

An 8-Week, Double-Blind, Placebo-Controlled, Phase 3 Trial of Pregabalin (150-600 mg/Day) in the Adjunctive Treatment of Patients With Generalized Anxiety Disorder (GAD) Who Have Not Optimally Responded to Existing Therapies(GAD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy of pregabalin as compared to placebo in the treatment of patients with general anxiety disorder (GAD). Efficacy will be measured by the improvement in the total Hamilton Anxiety Rating Scale (HAM-A) scores from baseline observed following 8 weeks of double-blind treatment or at earlier termination during the double-blind treatment phase and analyzed using a mixed linear model for repeated measures.

Detailed description

Further enrollment in this study was stopped on January 28, 2008 based on the recommendation of an independent data monitoring committee. The recommendation to stop the study was not based on any safety findings.

Conditions

• Generalized Anxiety Disorder

Interventions

Type	Name	Description
DRUG	pregabalin	pregabalin 150-600 mg/day flexibly dosed for the first 6 weeks and fixed dosed for the last 2 weeks of total 8 weeks of double blind study period, + concurrent GAD treatment from the open-label study period
DRUG	placebo	placebo + concurrent GAD treatment from the open-label study period

Timeline

• Start date: 2006-12-01
• Primary completion: 2008-02-01
• Completion: 2008-03-01
• First posted: 2006-12-19
• Last updated: 2021-02-10
• Results posted: 2009-12-02

Locations

68 sites across 8 countries: United States, Czechia, Estonia, Finland, Hungary, Russia, Serbia, Ukraine