Efficacy and tolerability of escitalopram in 12-and 24-week treatment of social anxiety disorder:: Randomised, double-blind, placebo-controlled, fixed-dose study

Efficacy and tolerability of escitalopram in 12-and 24-week treatment of social anxiety disorder:: Randomised, double-blind, placebo-controlled, fixed-dose study
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DOI:
10.1002/da.20014
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发表时间:
2004-01-01
影响因子:
7.4
通讯作者:
Nil, R
Nil, R
中科院分区:
医学1区
文献类型:
--
作者:
Lader, M;Stender, K;Nil, R

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选择性5-羟色胺再摄取抑制剂是治疗社交焦虑症(SAD)的首选药物。使用帕罗西汀作为活性对照,比较了固定剂量艾司西酞普兰与安慰剂长期治疗全身性SAD的疗效和耐受性。年龄在18 - 65岁之间的DSM-IV诊断为SAD的患者被随机分配至安慰剂(n = 166)、5 mg艾司西酞普兰(n = 167)、10 mg艾司西酞普兰(n = 167)、20 mg艾司西酞普兰(n = 170)或20 mg帕罗西汀(n = 169)的24周双盲治疗。基于主要疗效参数,第12周Liebowitz社交焦虑量表(LSAS)总评分(LOCF),5和20 mg艾司西酞普兰以及OC分析的所有剂量的治疗效果均显著优于安慰剂。第24周时,观察到LSAS评分进一步改善(OC和LOCF),所有剂量的艾司西酞普兰均显著优于安慰剂,20 mg艾司西酞普兰显著上级优于20 mg帕罗西汀。第12周时,所有活性药物治疗的治疗应答(通过临床疗效总评量表-改善评分≤ 2评估)均显著高于安慰剂。所有Sheehan残疾评分的显著降低和艾司西酞普兰治疗的良好耐受性支持了临床相关性。可以得出结论,5 - 20 mg剂量的艾司西酞普兰在全身性SAD的短期和长期治疗中有效且耐受性良好。(C)2004 Wiley-Liss,Inc.
Selective serotonin reuptake inhibitors are the pharmacological treatment of choice for the treatment of social anxiety disorder (SAD). The efficacy and tolerability of fixed doses of escitalopram were compared to those of placebo in the long-term treatment of generalised SAD, using paroxetine as an active reference. Patients with a DSM-IV diagnosis of SAD between 18-65 years of age were randomised to 24 weeks of double-blind treatment with placebo (n = 166), 5 mg escitalopram (n = 167), 10 mg escitalopram (n = 167), 20 mg escitalopram (n = 170), or 20 mg paroxetine (n = 169). Based on the primary efficacy parameter, Liebowitz Social Anxiety Scale (LSAS) total score at Week 12 (LOCF), a significantly superior therapeutic effect compared to placebo was seen for 5 and 20 mg escitalopram and for all doses for the OC analyses. Further improvement in LSAS scores was seen at Week 24 (OC and LOCF), with significant superiority over placebo for all doses of escitalopram, and 20 mg escitalopram was significantly superior to 20 mg paroxetine. Response to treatment (assessed by a Clinical Global Impression-Improvement score less than or equal to 2) was significantly higher for all active treatments than for placebo at Week 12. Clinical relevance was supported by a significant decrease in all the Sheehan disability scores, and the good tolerability of escitalopram treatment. It is concluded that doses of 5-20 mg escitalopram are effective and well tolerated in the short- and long-term treatment of generalised SAD. (C) 2004 Wiley-Liss, Inc.