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首页> 外文期刊>The journal of clinical psychiatry >The efficacy of agomelatine in elderly patients with recurrent major depressive disorder: A placebo-controlled study
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The efficacy of agomelatine in elderly patients with recurrent major depressive disorder: A placebo-controlled study

机译：阿戈美拉汀对老年复发性重度抑郁症患者的疗效：安慰剂对照研究

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Objective: The present placebo-controlled study evaluated the efficacy, tolerability, and safety of 8-week treatment with agomelatine (25-50 mg/d by mouth) in elderly patients with major depressive disorder (MDD). Method: Elderly outpatients aged ≥ 65 years with a primary diagnosis of moderate to severe episode of recurrent MDD (DSM-IV-TR) were recruited in 27 clinical centers in Argentina, Finland, Mexico, Portugal, and Romania from November 2009 to October 2011. The primary outcome measure was the 17-item Hamilton Depression Rating Scale (HDRS17) total score. Results: A total of 222 elderly patients entered the study (151 in the agomelatine group, 71 in the placebo group), including 69 patients aged 75 years and older. Agomelatine improved depressive symptoms in the elderly population, as evaluated by the HDRS17 total score, in terms of last postbaseline value (agomelatine-placebo difference: mean estimate [standard error] = 2.67 [1.06] points; P = .013) and response to treatment (agomelatine, 59.5%; placebo, 38.6%; P = .004). The agomelatine-placebo difference according to the Clinical Global Impressions-Severity of Illness scale (CGI-S) score was 0.48 (0.19). The agomelatine-placebo difference (estimate [standard error]) for remission on the HDRS17 was 6.9% (4.7%) and did not achieve statistical significance (P = .179, post hoc analysis). Clinically relevant effects of agomelatine were confirmed on all end points in the subset of severely depressed patients (HDRS17 total score ≥ 25 and CGI-S score ≥ 5 at baseline). Agomelatine was well tolerated by patients, with only minimal distinctions from placebo. Conclusions: The present study provides the first evidence that an 8-week treatment with agomelatine 25-50 mg/d efficiently relieves depressive symptoms and is well tolerated in elderly depressed patients older than 65 years.
机译：目的：本安慰剂对照研究评估了老年抑郁症（MDD）老年患者使用阿戈美拉汀（口服口服25-50 mg / d）治疗8周的疗效，耐受性和安全性。方法：2009年11月至2011年10月，在阿根廷，芬兰，墨西哥，葡萄牙和罗马尼亚的27个临床中心招募了≥65岁，初次诊断为中度至重度复发性MDD的老年门诊患者（DSM-IV-TR）主要结果指标是17个项目的汉密尔顿抑郁量表（HDRS17）总分。结果：共有222名老年患者进入研究（阿戈美拉汀组为151名，安慰剂组为71名），包括69名年龄在75岁及以上的患者。根据最新的HDRS17总评分评估，阿戈美拉汀改善了老年人的抑郁症状，依据的是基线后的最新值（阿戈美拉汀与安慰剂的差异：平均估计值[标准误] = 2.67 [1.06]分; P = 0.013）和治疗（阿戈美拉汀，59.5％;安慰剂，38.6％; P = 0.004）。根据临床总体印象-疾病严重程度评分（CGI-S）评分，阿戈美拉汀-安慰剂差异为0.48（0.19）。 HDRS17缓解的阿戈美拉汀-安慰剂差异（估计[标准误差]）为6.9％（4.7％），且未达到统计学显着性（P = .179，事后分析）。在严重抑郁症患者亚组的所有终点（基线时HDRS17总得分≥25和CGI-S得分≥5）上均证实了阿戈美拉汀的临床相关作用。患者对阿戈美拉汀的耐受性良好，与安慰剂的区别很小。结论：本研究提供了第一个证据，即用25-50 mg / d阿戈美拉汀进行8周治疗可有效缓解抑郁症状，并且对65岁以上的抑郁症患者具有良好的耐受性。

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