Suicidality in pediatric patients treated with antidepressant drugs
Suicidality in pediatric patients treated with antidepressant drugs
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DOI：
10.1001/archpsyc.63.3.332
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发表时间：
2006-03-01
影响因子：
--
通讯作者：
Racoosin, J
中科院分区：
文献类型：
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作者：
Hammad, TA;Laughren, T;Racoosin, J
背景：人们一直担心，广泛使用的抗抑郁药物可能与儿科患者自杀意念和行为（自杀）风险增加有关。目的：通过随机、安慰剂对照试验，探讨抗抑郁药物与儿童自杀的关系。数据来源：数据来自9个药物公司支持的评估儿科患者抗抑郁药物有效性的项目中的23个试验，以及1个评估盐酸氟西汀治疗的多中心试验（青少年抑郁症治疗研究）。研究选择：所有提交给食品和药物管理局的安慰剂对照试验均符合入选条件。可评估的数据来自24项试验的4582例患者。16项试验研究了重度抑郁症患者，其余8项试验研究了强迫症（n=4）、广泛性焦虑症（n=2）、注意力缺陷/多动障碍（n=1）和社交焦虑症（n=1）。只有20个试验被纳入自杀风险比分析，因为4个试验在药物组或安慰剂组中没有发生事件。数据提取：所有试验均可获得个体患者数据。数据综合：进行了荟萃分析，以获得每种药物单独的总体自杀风险估计，选择性血清素再摄取抑制剂在抑郁症试验中作为一个组，以及所有可评估的试验组合。在所有这些试验中都没有发生自杀。多中心试验是唯一显示有统计学显著风险比的个体试验（4.62；95%可信区间[CI]， 1.02-20.92）。抑郁症试验中选择性血清素再摄取抑制剂的总风险比为1.66 (95% CI, 1.02-2.68)，所有适应症的所有药物的总风险比为1.95 （95% CI, 1.28-2.98）。所有适应症中所有药物的总风险差异为0.02 （95% CI, 0.01-0.03）。结论：儿科患者使用抗抑郁药物与轻度增加自杀风险相关。
Context: There has been concern that widely used antidepressant agents might be associated with an increased risk of suicidal ideation and behavior (suicidality) in pediatric patients.Objective: To investigate the relationship between antidepressant drugs and suicidality in pediatric patients participating in randomized, placebo-controlled trials.Data Sources: Data were derived from 23 trials conducted in 9 drug company-supported programs evaluating the effectiveness of antidepressants in pediatric patients and 1 multicenter trial (the Treatment for Adolescents With Depression Study) that evaluated fluoxetine hydrochloride.Study Selection: All placebo-controlled trials submitted to the Food and Drug Administration were eligible for inclusion. Evaluable data were derived from 4582 patients in 24 trials. Sixteen trials studied patients with major depressive disorder, and the remaining 8 studied obsessive-compulsive disorder (n=4), generalized anxiety disorder (n=2), attention-deficit/hyperactivity disorder (n=1), and social anxiety disorder (n=1). Only 20 trials were included in the risk ratio analysis of suicidality because 4 trials had no events in the drug or placebo groups.Data Extraction: Individual patient data were available for all the trials.Data Synthesis: A meta-analysis was conducted to obtain overall suicidality risk estimates for each drug individually, for selective serotonin reuptake inhibitors in depression trials as a group, and for all evaluable trials combined. There were no completed suicides in any of these trials. The multicenter trial was the only individual trial to show a statistically significant risk ratio (4.62; 95% confidence interval [CI], 1.02-20.92). The overall risk ratio for selective serotonin reuptake inhibitors in depression trials was 1.66 (95% CI, 1.02-2.68) and for all drugs across all indications was 1.95 (95% CI, 1.28-2.98). The overall risk difference for all drugs across all indications was 0.02 (95% CI, 0.01-0.03).Conclusion: Use of antidepressant drugs in pediatric patients is associated with a modestly increased risk of suicidality.