The present paper reports in parallel the findings of the two phase III trials that evaluated the efficacy of agomelatine in older depressed patients. It describes how the particular methodological innovations (particularly in relation to patient selection, design and accuracy of diagnosis of depression) introduced in study 2 have improved the quality of recruitment of patients and the assay sensitivity. Study 1 lacked assay sensitivity, and among the many differences with study 2, the inclusion of unexpected mildly ill patients could have inflated the placebo response. The increased demands on investigators in study 2 appear to have reduced the placebo effect and showed a robust benefit of agomelatine. The two agomelatine studies offer the opportunity to discuss hypotheses that have been raised to explain the low level of response of older patients to available antidepressants.

中文翻译：

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老年抑郁症患者的抗抑郁作用：两项阿戈美拉汀试验的教训。

本论文同时报告了两项 III 期试验的结果，这些试验评估了阿戈美拉汀对老年抑郁症患者的疗效。它描述了研究 2 中引入的特定方法创新（特别是与患者选择、设计和抑郁症诊断准确性相关的）如何提高了患者招募的质量和检测灵敏度。研究 1 缺乏检测敏感性，在与研究 2 的许多差异中，包括意外的轻症患者可能会夸大安慰剂反应。研究 2 中对研究人员的需求增加似乎降低了安慰剂效应，并显示出阿戈美拉汀的强大益处。