Carandang Carlo, Jabbal Rekha, Macbride Angela, Elbe Dean
Mental Health and Addictions Program, IWK Health Centre, Halifax, Nova Scotia.
J Can Acad Child Adolesc Psychiatry. 2011 Nov;20(4):315-24.
To review the basic pharmacology and published literature regarding escitalopram and citalopram in child and adolescent depression.
A LITERATURE REVIEW WAS CONDUCTED USING THE SEARCH TERMS: 'escitalopram', 'citalopram', 'depression', 'randomized controlled trial', 'open label trial' and limits set to: Human trials, English Language and All Child (Age 0-18). Additional articles were identified from reference information and poster presentation data.
Three prospective, randomized controlled trials (RCT) were found for escitalopram in pediatric depression, and two RCTs were found for citalopram. One RCT each for escitalopram and citalopram showed superiority over placebo on the primary out come measure. Adverse effects in escitalopram and citalopram trials were generally mild to moderate. Suicidality was not assessed systematically in all RCTs reviewed, but did not appear to be elevated over placebo in escitalopram RCTs. One trial reported numerically higher suicide related events for citalopram compared to placebo (14 vs. 5, p=0.06).
At present, escitalopram and citalopram should be considered a second-line option for adolescent depression. The US Food and Drug Administration approval of escitalopram for treatment of adolescent depression was based on a single positive RCT. This is less evidence than typically required for approval of a drug for a new indication.
综述关于艾司西酞普兰和西酞普兰用于儿童及青少年抑郁症的基础药理学及已发表文献。
使用检索词“艾司西酞普兰”“西酞普兰”“抑郁症”“随机对照试验”“开放标签试验”进行文献综述,并将检索范围限定为:人体试验、英语文献以及所有儿童(0 - 18岁)。通过参考文献信息和海报展示数据确定了其他文章。
发现三项关于艾司西酞普兰治疗儿童抑郁症的前瞻性随机对照试验(RCT),以及两项关于西酞普兰的RCT。艾司西酞普兰和西酞普兰各有一项RCT在主要结局指标上显示优于安慰剂。艾司西酞普兰和西酞普兰试验中的不良反应一般为轻至中度。在所有纳入综述的RCT中,未对自杀倾向进行系统评估,但在艾司西酞普兰RCT中,自杀倾向似乎并未高于安慰剂组。一项试验报告,与安慰剂相比,西酞普兰的自杀相关事件在数值上更高(14例对5例,p = 0.06)。
目前,艾司西酞普兰和西酞普兰应被视为青少年抑郁症的二线治疗选择。美国食品药品监督管理局批准艾司西酞普兰用于治疗青少年抑郁症是基于一项阳性RCT。这一证据比通常批准一种药物用于新适应症所需的证据要少。