Suicidal adverse events in pediatric randomized, controlled clinical trials of antidepressant drugs are associated with active drug treatment: A meta-analysis
Suicidal adverse events in pediatric randomized, controlled clinical trials of antidepressant drugs are associated with active drug treatment: A meta-analysis
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DOI：
10.1089/cap.2006.16.25
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发表时间：
2006-02-01
影响因子：
1.9
通讯作者：
Willy, M
中科院分区：
文献类型：
--
作者：
Mosholder, AD;Willy, M
目的：本研究的目的是比较自杀意念和行为的发生率与抗抑郁药物治疗的发生率与安慰剂，在随机，对照pediatric clinical trials.Methods：制造商的9种抗抑郁药物确定自杀的不良事件在随机，安慰剂对照，儿科临床试验，他们已经赞助。通过电子检索不良事件描述（包括提示自杀意念或自伤的关键词）以及对符合标准监管严重性定义的所有不良事件进行手动审查沿着发现事件。由制造商提供的这些事件的发生率数据进行了合并跨试验产生Mantel-Haenszel合并risk estimate.Results：数据来自22个随机，短期，安慰剂对照，儿科试验在各种适应症，涉及9种不同的抗抑郁药物，可用于分析。共有2298例儿童受试者暴露于活性药物，1952例暴露于安慰剂。这些试验中发生了78起严重自杀不良事件（活性药物组54起，安慰剂组24起）;无自杀既遂事件。所有试验中严重自杀不良事件的合并发生率比为1.89（95%置信区间，1.18-3.04）。结论：在短期、安慰剂对照、儿科抗抑郁药研究中，活性药物治疗与严重自杀事件发生率相关，几乎是安慰剂治疗的两倍。
Objective: The aim of this study was to compare the incidence of suicidal ideation and behaviors observed with antidepressant drug treatment to the incidence with placebo, in randomized, controlled pediatric clinical trials.Methods: Manufacturers of nine antidepressant drugs identified suicidal adverse events in randomized, placebo-controlled, pediatric clinical trials that they had sponsored. Events were found with an electronic search for adverse event descriptions, including key words suggesting suicidal ideation or self-injury, along with a manual review of all adverse events meeting the standard regulatory definition for seriousness. Incidence rate data for these events supplied by the manufacturers were combined across trials to yield Mantel-Haenszel combined risk estimates.Results: Data from 22 randomized, short-term, placebo-controlled, pediatric trials in various indications, involving nine different antidepressant drugs, were available for analysis. A total of 2298 pediatric subjects were exposed to active drug, and 1952 to placebo. Seventy-eight (78) serious suicidal adverse events occurred in these trials (54 with active drug and 24 with placebo); there were no completed suicides. The combined incidence rate ratio across all trials for serious suicidal adverse events was 1.89 (95% Confidence Interval, 1.18-3.04).Conclusions: In short-term, placebo-controlled, pediatric studies of antidepressants, active drug treatment was associated with a rate of serious suicidal events almost twice that of placebo.