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首页> 外文期刊>Pediatrics: Official Publication of the American Academy of Pediatrics >Analysis of pediatric clinical drug trials for neuropsychiatric conditions
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Analysis of pediatric clinical drug trials for neuropsychiatric conditions

机译：儿科临床药物试验对神经精神疾病的分析

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BACKGROUND AND OBJECTIVE: Neuropsychiatric conditions represent a large and increasing disease burden in children. A number of drugs are available for the treatment of these conditions, but most drugs have not been adequately tested in children, and off-label drug use remains widespread. We sought to define and quantify recent and ongoing clinical research on the use of neuropsychiatric drugs in children. METHODS: Drug trials registered in ClinicalTrials.gov between 2006 and 2011 and studying neuropsychiatric conditions were selected and classified based on the drug's Food and Drug Administration (FDA) approval status in children. We measured the proportion of trials seeking to expand the use of a drug to pediatric patients and the proportion of available drugs studied in children. RESULTS: Only 10% of neuropsychiatric trials focused on children. Of 303 drugs studied in both pediatric and adult populations, 90% lacked FDA approval in children and 97% were not approved in children for the indication studied. However, only 19% of all neuropsychiatric drugs were under study in pediatric populations, with as few as 8% of either antidepressant or antipsychotic drugs. Overall, 76% of pediatric drug trials examined a drug previously unapproved in children and 26% explored the use of a drug for a new indication. CONCLUSIONS: Despite the rising prevalence of neuropsychiatric disease and the paucity of FDA-approved pediatric drugs, only a small proportion of trials focus on pediatric populations and these trials cover only a fraction of available drugs. This deficiency is most pronounced for depression and schizophrenia.
机译：背景与目的：神经精神疾病代表儿童的疾病负担越来越大。有多种药物可用于治疗这些疾病，但是大多数药物尚未在儿童中进行充分测试，且标签外药物的使用仍很普遍。我们试图定义和量化有关儿童神经精神科药物使用的最新和正在进行的临床研究。方法：根据药物在儿童食品和药物管理局（FDA）的批准状态，选择2006年至2011年在ClinicalTrials.gov中注册并研究神经精神疾病的药物试验并进行分类。我们测量了试图扩大对儿科患者使用药物的试验的比例以及在儿童中研究的可用药物的比例。结果：只有10％的神经精神病学研究针对儿童。在儿科和成人人群中研究的303种药物中，有90％的儿童缺乏FDA批准，而97％的儿童没有获得FDA批准用于所研究的适应症。但是，在儿童人群中仅研究了所有神经精神科药物中的19％，而抗抑郁药或抗精神病药的比例仅为8％。总体而言，有76％的儿科药物试验检查了以前未在儿童中使用的药物，而26％的人尝试将药物用于新的适应症。结论：尽管神经精神疾病的患病率上升且FDA批准的儿科药物匮乏，但只有一小部分试验着重于儿科人群，这些试验仅涵盖了可用药物的一小部分。这种缺陷在抑郁症和精神分裂症中最为明显。

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