open access

https://hdl.handle.net/2115/64956

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

英語

Social anxiety disorder (SAD)

2016

Taylor & Francis

Current medical research and opinion

32(4)

749-757

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<0.001) (MMRM, FAS) (escitalopram 20mg). Common adverse events (incidence ≥5% and significantly different from placebo) were somnolence, nausea and ejaculation disorder. Conclusion: Escitalopram was efficacious, safe and well tolerated by patients with SAD in Japan. Study limitations are discussed including patient characteristics.

学術雑誌論文

Accepted Manuscript

This is an Accepted Manuscript of an article published by Taylor & Francis in Current Medical Research and Opinion in 2016, available online: http://www.tandfonline.com/10.1185/03007995.2016.1146663.

0300-7995

AA00621750