A randomized, double-blind, placebo-controlled study of escitalopram in patients with social anxiety disorder in Japan

Objective: This randomised, double-blind placebo-controlled study compared the efficacy and tolerability of escitalopram (10 and 20mg/day) in Japanese patients with social anxiety disorder (SAD). Research design and methods: Patients aged 18-64 years with a primary diagnosis of DSM-IV-TR defined SAD, a Liebowitz Social Anxiety Scale Japanese version (LSAS-J) total score ≥60 and a Clinical Global Impression-Severity (CGI-S) score ≥4 at baseline were randomly assigned (1:1:1) to placebo, escitalopram 10mg or 20mg. The primary endpoint was change from baseline to Week 12 in the LSAS-J total score for both escitalopram 10mg and 20mg versus placebo (ANCOVA, FAS, LOCF), using a hierarchical testing procedure. Pre-specified secondary endpoints included LSAS-J sensitivity analyses. Clinical trial registration: This study has the www.japic.or.jp identifier: JapicCTI-121842. Results: For the primary efficacy endpoint, the difference from placebo in the LSAS-J was -3.9 (p=0.089) for escitalopram 10mg. Since the superiority of escitalopram 10mg over placebo was not confirmed, an analysis without multiplicity adjustment was made, which showed a difference for escitalopram 20mg versus placebo of -9.8 (p<0.001). In pre-specified sensitivity analyses, the difference versus placebo was -4.9 (p=0.035) (ANCOVA, FAS, OC) and -5.0 (p=0.028) (MMRM, FAS) (escitalopram 10mg) and -10.1 (p<0.001) (ANCOVA, FAS, OC) and -10.6 (p