This work may not be copied, distributed, displayed, published, reproduced, transmitted, modified, posted, sold, licensed, or used for commercial purposes. By downloading this file, you are agreeing to the publisher’s Terms & Conditions.

Original Articles

Efficacy and Safety of Pregabalin in the Treatment of Generalized Anxiety Disorder: A 6-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Comparison of Pregabalin and Venlafaxine

Stuart A. Montgomery, MD; Kathy Tobias, MD; Gwen L. Zornberg, MD, ScD; Siegfried Kasper, MD, PhD; and Atul C. Pande, MD

Published: May 15, 2006

Article Abstract

Objective: Pregabalin has demonstrated robust, rapid efficacy in reducing symptoms of generalized anxiety disorder (GAD) in 4 placebo-controlled clinical trials. The current study compared the efficacy and safety of pregabalin and venlafaxine in patients diagnosed with moderate to severe GAD.

Method: The study was conducted from December 21, 1999, to July 31, 2001. Outpatients (N = 421) in primary care or psychiatry settings meeting DSM-IV criteria for GAD were randomly assigned to 6 weeks of double-blind treatment with pregabalin 400 or 600 mg/day, venlafaxine 75 mg/day, or placebo. The primary analysis was change in Hamilton Rating Scale for Anxiety (HAM-A) total score from baseline to last-observation-carried-forward (LOCF) endpoint. Secondary analyses included the change in HAM-A psychic (emotional) and somatic (physical) factor scores, significant improvement at week 1, and week 1 improvement sustained at every visit through endpoint.

Results: Pregabalin at both dosages (400 mg/day, p = .008; 600 mg/day, p = .03) and venlafaxine (p = .03) produced significantly greater improvement in HAM-A total score at LOCF endpoint than did placebo. Only the pregabalin 400-mg/day treatment group experienced significant improvement in all a priori primary and secondary efficacy measures. Pregabalin in both dosage treatment groups (400 mg/day, p < .01; 600 mg/day, p < .001) significantly improved HAM-A total score at week 1, with significant improvement through LOCF endpoint. Statistically significant improvement began at week 2 for venlafaxine. Discontinuation rates due to associated adverse events were greatest in the venlafaxine treatment group: venlafaxine, 20.4%; pregabalin 400 mg/day, 6.2%; pregabalin 600 mg/day, 13.6%; placebo, 9.9%.

Conclusion: Pregabalin was safe, well tolerated, and rapidly efficacious across the physical-somatic as well as the emotional symptoms of GAD in the majority of patients studied in primary care and psychiatric settings.

Volume: 67

Quick Links: Anxiety

Continue Reading…

Subscribe to read the entire article

$40.00

Buy this Article as a PDF

Sign-up to stay
up-to-date today!

SUBSCRIBE

Already registered? Sign In

Clinical and Practical Psychopharmacology

Skeletal and Dental Fractures Associated With Electroconvulsive Therapy

Recent data suggest the risk of skeletal or dental fracture with ECT may be as low as...

Read More...