Mirtazapine in generalized social anxiety disorder: a randomized, double-blind, placebo-controlled study.

This study is aimed at investigating the efficacy and tolerability of mirtazapine in a generalized social anxiety disorder. Sixty patients with generalized social anxiety disorder were randomly allocated to receive mirtazapine (30-45 mg/day) (n= 30) or placebo (n= 30) for 12 weeks in a double-blind study design. Primary efficacy was assessed by the Liebowitz Social Anxiety Scale (LSAS) and response to treatment was defined as a reduction of 40% on the LSAS and an improvement on the Clinical Global Impression scale of 'much or very much improved'. An intent-to-treat analysis showed no difference between mirtazapine and placebo on the absolute LSAS scores with a mean decrease of 13.5 +/- 16.9 and 11.2 +/- 17.8 respectively, and on the number of responders, 13 and 13%, respectively. In conclusion, mirtazapine (30-45 mg/day) failed to be effective in the generalized social anxiety disorder.