艾司西酞普兰可预防老年重度抑郁症患者复发。

Escitalopram prevents relapse in older patients with major depressive disorder.

作者信息

Gorwood Philip, Weiller Emmanuelle, Lemming Ole, Katona Cornelius

机构信息

From INSERM U675, Paris, France.

出版信息

Am J Geriatr Psychiatry. 2007 Jul;15(7):581-93. doi: 10.1097/01.JGP.0000240823.94522.4c.

DOI:10.1097/01.JGP.0000240823.94522.4c

PMID:17586783

Abstract

OBJECTIVE

The present study investigated the efficacy and tolerability of escitalopram in the prevention of relapse of major depressive disorder (MDD) in older patients who had responded to acute treatment with escitalopram.

METHOD

A total of 405 patients who were aged 65 years or older with a primary diagnosis of MDD (according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition criteria) and a Montgomery-Asberg Depression Rating Scale (MADRS) total score of 22 or more received 12-week, open-label escitalopram 10 or 20 mg per day treatment. Remitters (MADRS </=12) were randomized to 24-week double-blind treatment with escitalopram or placebo. The primary efficacy parameter was the time to relapse, defined as either an increase in MADRS total score to 22 or more or lack of efficacy as judged by the investigator.

RESULTS

Three hundred five patients achieved remission and were randomly assigned to treatment with escitalopram (N = 152) or placebo (N = 153). The primary analysis showed a clear beneficial effect of escitalopram relative to placebo on the time to relapse (log-rank test, chi(2) = 27.6, df = 1, p <0.001). The risk of relapse was 4.4 times higher for placebo- than for escitalopram-treated patients (chi(2) test, chi(2) = 22.9, df = 1, p <0.001). Significantly fewer escitalopram-treated patients relapsed (9%) compared with placebo (33%) (chi(2) test, chi(2) = 27.1, df = 1, p <0.001). Escitalopram was well tolerated with 53 patients (13%) withdrawn as a result of adverse events during the open-label period and three (2%) escitalopram-treated patients and six (4%) placebo-treated patients during double-blind treatment (not significant). The overall withdrawal rate, excluding relapses, was 7.2% for escitalopram and 8.5% for placebo during the double-blind period (not significant).

CONCLUSION

Escitalopram was effective in preventing relapse of MDD in older patients and was well tolerated as continuation treatment.

摘要

目的

本研究调查了艾司西酞普兰在预防已对艾司西酞普兰急性治疗有反应的老年患者重度抑郁症（MDD）复发方面的疗效和耐受性。

方法

共有405名年龄在65岁及以上、初步诊断为MDD（根据《精神疾病诊断与统计手册》第四版标准）且蒙哥马利-阿斯伯格抑郁评定量表（MADRS）总分在22分及以上的患者接受了为期12周的开放标签的艾司西酞普兰治疗，剂量为每日10或20毫克。症状缓解者（MADRS≤12）被随机分配接受为期24周的艾司西酞普兰或安慰剂双盲治疗。主要疗效参数为复发时间，定义为MADRS总分增加至22分及以上或研究者判定为治疗无效。

结果

305名患者实现症状缓解并被随机分配接受艾司西酞普兰治疗（N = 152）或安慰剂治疗（N = 153）。初步分析显示，相对于安慰剂，艾司西酞普兰在复发时间方面有明显的有益效果（对数秩检验，χ² = 27.6，自由度 = 1，p <0.001）。安慰剂治疗患者的复发风险比艾司西酞普兰治疗患者高4.4倍（χ²检验，χ² = 22.9，自由度 = 1，p <0.001）。与安慰剂组（33%）相比，接受艾司西酞普兰治疗的患者复发率显著更低（9%）（χ²检验，χ² = 27.1，自由度 = 1，p <0.001）。艾司西酞普兰耐受性良好，在开放标签期有53名患者（13%）因不良事件退出，在双盲治疗期间，接受艾司西酞普兰治疗的患者有3名（2%）、接受安慰剂治疗的患者有6名（4%）退出（无显著性差异）。在双盲期，排除复发因素后，艾司西酞普兰的总体退出率为7.2%，安慰剂为8.5%（无显著性差异）。