Severity of depression and response to antidepressants and placebo: An analysis of the Food and Drug Administration database
Severity of depression and response to antidepressants and placebo: An analysis of the Food and Drug Administration database
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DOI：
10.1097/00004714-200202000-00007
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发表时间：
2002-02-01
影响因子：
2.9
通讯作者：
Brown, WA
中科院分区：
文献类型：
--
作者：
Khan, A;Leventhal, RM;Brown, WA
一些研究表明，病情较重的抑郁症患者对抗抑郁药的反应良好，而安慰剂的反应较差，而那些病情较轻的患者对抗抑郁药和安慰剂的反应同样良好。这一概念对临床试验的设计具有启示意义。为了进一步评估和证实这些抗抑郁药和安慰剂反应的推定预测因子，我们评估了食品和药物管理局45个11期和III期抗抑郁药临床试验数据库。在包括更严重抑郁症患者的试验中，抗抑郁药和安慰剂之间统计学显著差异的频率更高。在抗抑郁药治疗组中，症状减轻的程度与平均初始汉密尔顿抑郁量表（HAM-D）评分显著相关;平均初始HAM-D评分越高，变化越大。然而，使用安慰剂治疗，平均初始HAM-D评分越高，变化越小。早期停药在平均初始HAM-D评分较高的患者中更常见。这些数据可能有助于为未来抗抑郁药临床试验的设计提供信息。
Some studies suggest that more severely ill patients with depression respond well to antidepressants and poorly to placebo, whereas those who are mildly ill respond equally well to antidepressants and placebo. This notion has implications for the design of clinical trials. To further assess and substantiate these putative predictors of antidepressant and placebo response, we assessed the Food and Drug Administration database of 45 phase 11 and III antidepressant clinical trials. The frequency of statistically significant differences between antidepressants and placebo was higher in the trials that included patients with more severe depression. In the antidepressant-treated groups, the magnitude of symptom reduction was significantly related to mean initial Hamilton Rating Scale for Depression (HAM-D) score; the higher the mean initial HAM-D score, the larger the change. With placebo treatment, however, the higher the mean initial HAM-D score, the smaller the change. Early discontinuation was more frequent among patients whose mean initial HAM-D scores were higher. These data may help inform the design of future antidepressant clinical trials.