一项关于艾司西酞普兰预防广泛性社交焦虑障碍的为期24周的随机、双盲、安慰剂对照研究。

A 24-week randomized, double-blind, placebo-controlled study of escitalopram for the prevention of generalized social anxiety disorder.

作者信息

Montgomery Stuart A, Nil Rico, Dürr-Pal Natalie, Loft Henrik, Boulenger Jean-Philippe

机构信息

Imperial College, London, UK.

出版信息

J Clin Psychiatry. 2005 Oct;66(10):1270-8. doi: 10.4088/jcp.v66n1009.

DOI:10.4088/jcp.v66n1009

PMID:16259540

Abstract

OBJECTIVE

Escitalopram has proven efficacy in the short-term treatment of generalized social anxiety disorder (SAD). The present relapse prevention study investigated relapse rates during a 24-week, randomized, double-blind, placebo-controlled period in patients with generalized SAD who had responded to 12-week open-label treatment with escitalopram.

METHOD

A total of 517 patients with a primary diagnosis of generalized SAD (per DSM-IV criteria) and a Liebowitz Social Anxiety Scale (LSAS) total score of > or = 70 received 12 weeks of open-label treatment with flexible doses (10-20 mg/day) of escitalopram. Of these patients, 371 responded (Clinical Global Impressions-Improvement scale [CGI-I] score of 1 or 2) and were randomly assigned to 24 weeks of double-blind treatment with escitalo-pram (10 or 20 mg/day) (N = 190) or placebo (N = 181), continuing with the dose level administered at the end of the open-label period. Relapse was defined as either an increase in LSAS total score of > or = 10 or withdrawal due to lack of efficacy, as judged by the investigator. The study was conducted from January 2001 to June 2002.

RESULTS

Survival analysis of relapse and time to relapse showed a significant advantage for escitalopram compared to placebo (log-rank test: p < .001). The risk of relapse was 2.8 times higher for placebo-treated patients than for escitalopram-treated patients (p < .001), resulting in significantly fewer escitalopram-treated patients relapsing (22% vs. 50%), at both doses. Escitalopram was well tolerated during double-blind treatment of generalized SAD, and only 2.6% of the escitalopram-treated patients withdrew because of adverse events. The overall discontinuation rate, excluding relapses, was 13.2% for patients treated with escitalopram and 8.3% for patients treated with placebo.

CONCLUSION

Escitalopram was effective and well tolerated in the long-term treatment of generalized SAD.

摘要

目的

艾司西酞普兰已被证实在广泛性社交焦虑障碍（SAD）的短期治疗中有效。本预防复发研究调查了对艾司西酞普兰进行12周开放标签治疗有反应的广泛性SAD患者在24周随机、双盲、安慰剂对照期内的复发率。

方法

共有517例原发性广泛性SAD患者（根据DSM-IV标准）且利博维茨社交焦虑量表（LSAS）总分≥70，接受了为期12周的艾司西酞普兰灵活剂量（10 - 20毫克/天）开放标签治疗。其中，371例有反应（临床总体印象改善量表[CGI-I]评分为1或2），并被随机分配接受24周双盲治疗，服用艾司西酞普兰（10或20毫克/天）（N = 19）或安慰剂（N = 181），继续使用开放标签期结束时给予的剂量水平。复发定义为LSAS总分增加≥10或因缺乏疗效而由研究者判断停药。该研究于2001年1月至2002年6月进行。

结果

复发及复发时间的生存分析显示，与安慰剂相比，艾司西酞普兰具有显著优势（对数秩检验：p < 0.001）。接受安慰剂治疗的患者复发风险比接受艾司西酞普兰治疗的患者高2.8倍（p < 0.001），导致两种剂量下接受艾司西酞普兰治疗的患者复发明显更少（22%对50%）。在广泛性SAD的双盲治疗期间，艾司西酞普兰耐受性良好，仅2.6%接受艾司西酞普兰治疗的患者因不良事件停药。排除复发情况，接受艾司西酞普兰治疗患者的总体停药率为13.2%，接受安慰剂治疗患者的总体停药率为8.3%。