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Hokkaido University Collection of Scholarly and Academic Papers >
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A randomized, double-blind, placebo-controlled study of escitalopram in patients with social anxiety disorder in Japan
| Title: | A randomized, double-blind, placebo-controlled study of escitalopram in patients with social anxiety disorder in Japan |
| Authors: | Asakura, Satoshi Browse this author | | Hayano, Taiji Browse this author | | Hagino, Atsushi Browse this author | | Koyama, Tsukasa Browse this author →KAKEN DB |
| Keywords: | Escitalopram | | Japan | | Liebowitz Social Anxiety Scale Japanese version (LSAS-J) | | Randomized placebo-controlled study | | Social anxiety disorder (SAD) |
| Issue Date: | 2016 |
| Publisher: | Taylor & Francis |
| Journal Title: | Current medical research and opinion |
| Volume: | 32 |
| Issue: | 4 |
| Start Page: | 749 |
| End Page: | 757 |
| Publisher DOI: | 10.1185/03007995.2016.1146663 |
| PMID: | 26808688 |
| Abstract: | 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. |
| Rights: | 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. |
| Type: | article (author version) |
| URI: | http://hdl.handle.net/2115/64956 |
| Appears in Collections: | 医学院・医学研究院 (Graduate School of Medicine / Faculty of Medicine) > 雑誌発表論文等 (Peer-reviewed Journal Articles, etc)
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Submitter: 朝倉 聡
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