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Efficacy of pregabalin in generalized social anxiety disorder: results of a double-blind, placebo-controlled, fixed-dose study

Feltner, Douglas E.a; Liu-Dumaw, Mariab; Schweizer, Edwardc; Bielski, Robertd

International Clinical Psychopharmacology: July 2011 - Volume 26 - Issue 4 - p 213–220
doi: 10.1097/YIC.0b013e32834519bd
Original Articles

The objective of this study was to evaluate the efficacy and tolerability of pregabalin for the treatment of generalized social anxiety disorder (SAD). Patients with generalized SAD, who met the Diagnostic and Statistical Manual of Mental Disorders (fourth edition) criteria (total N=329), were randomly assigned to 11 weeks of double-blind treatment with fixed daily doses of either pregabalin (300, 450, and 600(mg) or placebo. The treatment with pregabalin (600(mg) was associated with a significantly greater mean reduction in the Liebowitz Social Anxiety Scale total score, from baseline to endpoint, compared with placebo (-29.8 vs. -19.7; P= 0.0099), whereas reduction on pregabalin (300(mg, -20.2) and pregabalin (450(mg, -25.5) was not significant Treatment with pregabalin (600(mg) was also associated with a significantly greater improvement than placebo on the fear and avoidance subscales of the Liebowitz Social Anxiety Scale, as well as the majority of other secondary measures. Onset of improvement occurred by week 1 in the pregabalin 600-mg dose group. The most common adverse events on all three doses of pregabalin were somnolence and dizziness. Consistent with a previous study, the results of this study suggest that the 600-mg dose of pregabalin per day may be efficacious in the treatment of SAD.

aDepartment of Psychiatry, University of Michigan, Ann Arbor

bDepartment of Psychiatry, Michigan State University, East Lansing, Michigan,

cMLD Consulting, Cary, North Carolina

dPaladin Consulting Group, Hoboken, New Jersey, USA

Correspondence to Douglas E. Feltner, MD, Department of Psychiatry, University of Michigan Depression Center, Rachel Upjohn Building, Anxiety Disorders Clinic, 4250 Plymouth Road, Ann Arbor, MI 48109-2700, USA e-mail:

Received September 27, 2010

Accepted January 27, 2011

© 2011 Lippincott Williams & Wilkins, Inc.