Blanco Carlos, Hoertel Nicolas, Franco Silvia, Olfson Mark, He Jian-Ping, López Saioa, González-Pinto Ana, Limosin Frédéric, Merikangas Kathleen R
Division of Epidemiology, Services, and Prevention Research, National Institute on Drug Abuse, Bethesda, Maryland.
Paris Descartes University, Pôles de recherche et d'enseignement supérieur Sorbonne Paris Cité, Paris, France;
Pediatrics. 2017 Dec;140(6). doi: 10.1542/peds.2016-1701. Epub 2017 Nov 2.
Although there have been a number of clinical trials evaluating treatments for adolescents with major depressive disorder (MDD), the generalizability of those trials to samples of depressed adolescents who present for routine clinical care is unknown. Examining the generalizability of clinical trials of pharmacological and psychotherapy interventions for adolescent depression can help administrators and frontline practitioners determine the relevance of these studies for their patients and may also guide eligibility criteria for future clinical trials in this clinical population.
Data on nationally representative adolescents were derived from the National Comorbidity Survey: Adolescent Supplement. To assess the generalizability of adolescent clinical trials for MDD, we applied a standard set of eligibility criteria representative of clinical trials to all adolescents in the National Comorbidity Survey: Adolescent Supplement with a diagnosis of MDD ( = 592).
From the overall MDD sample, 61.9% would have been excluded from a typical pharmacological trial, whereas 42.2% would have been excluded from a psychotherapy trial. Among those who sought treatment ( = 412), the corresponding exclusion rates were 72.7% for a pharmacological trial and 52.2% for a psychotherapy trial. The criterion leading to the largest number of exclusions was "significant risk of suicide" in both pharmacological and psychotherapy trials.
Pharmacological and, to a lesser extent, psychotherapy clinical trials likely exclude most adolescents with MDD. Careful consideration should be given to balancing eligibility criteria and internal validity with applicability in routine clinical care while ensuring patient safety.
尽管已有多项临床试验评估了针对青少年重度抑郁症（MDD）的治疗方法，但这些试验对于前来接受常规临床护理的抑郁症青少年样本的可推广性尚不清楚。研究针对青少年抑郁症的药物和心理治疗干预临床试验的可推广性，有助于管理人员和一线从业者确定这些研究对其患者的相关性，也可能为该临床人群未来的临床试验资格标准提供指导。
具有全国代表性的青少年数据来自全国共病调查：青少年补充调查。为评估青少年MDD临床试验的可推广性，我们将一组代表临床试验的标准资格标准应用于全国共病调查：青少年补充调查中所有诊断为MDD的青少年（=592）。
在整个MDD样本中，61.9%的人会被典型的药物试验排除，而42.2%的人会被心理治疗试验排除。在寻求治疗的人群中（=412），药物试验的相应排除率为72.7%，心理治疗试验为52.2%。在药物试验和心理治疗试验中，导致排除人数最多的标准都是“有显著自杀风险”。
药物治疗以及程度稍轻的心理治疗临床试验可能会排除大多数患有MDD的青少年。在确保患者安全的同时，应谨慎考虑平衡资格标准、内部有效性与在常规临床护理中的适用性。
