Columbia Classification Algorithm of Suicide Assessment (C-CASA): Classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants
Columbia Classification Algorithm of Suicide Assessment (C-CASA): Classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants
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DOI：
10.1176/appi.ajp.164.7.1035
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发表时间：
2007-07-01
影响因子：
17.7
通讯作者：
Davies, Mark
中科院分区：
文献类型：
--
作者：
Posner, Kelly;Oquendo, Maria A.;Davies, Mark
目的：评价抗抑郁药物与青少年自杀行为和意念（自杀）之间的联系，对儿科临床试验中的不良事件进行分类，以确定自杀事件。作者描述了哥伦比亚自杀评估分类算法（C-CASA），这是一个标准化的自杀评级系统，为食品和药物管理局（FDA）进行的抗抑郁药物的儿科自杀风险分析提供了数据。方法：对25例儿童抗抑郁药物临床试验的不良事件（427例）进行系统分析。随机分配的不良事件由9名独立专家中的3名使用哥伦比亚分类算法进行评估。评估了C-CASA评级的可靠性以及与制药公司分类的一致性。结果：在C-CASA中发现了26个最初未被制药公司识别的新的、可能自杀的事件（行为和意念），剔除了12个最初被制药公司标记为自杀的事件，总共产生了38个不一致的评分。对于“自杀未遂”的具体标签，C-CASA和制药公司的评级之间的一致性相对较低，C-CASA报告的评级降低了50%。因此，尽管C-CASA总体上导致了更多自杀事件的识别，但更少的事件被归类为自杀企图。此外，C-CASA评分具有高可靠性（类内相关系数[ICC]=0.89）。结论：利用系统的、固定的方法对自杀行为进行分类，可以准确、全面地识别自杀事件。FDA对C-CASA的审核证明了这种方法的良好可移植性。在最近的FDA成人抗抑郁药物安全性分析中，哥伦比亚算法被用于分类自杀不良事件，也被授权应用于所有抗惊厥药物试验和其他集中作用药物和非精神药物。
Objective: To evaluate the link between antidepressants and suicidal behavior and ideation (suicidality) in youth, adverse events from pediatric clinical trials were classified in order to identify suicidal events. The authors describe the Columbia Classification Algorithm for Suicide Assessment (C-CASA), a standardized suicidal rating system that provided data for the pediatric suicidal risk analysis of antidepressants conducted by the Food and Drug Administration (FDA).Method: Adverse events (N=427) from 25 pediatric antidepressant clinical trials were systematically identified by pharmaceutical companies. Randomly assigned adverse events were evaluated by three of nine independent expert suicidologists using the Columbia classification algorithm. Reliability of the C-CASA ratings and agreement with pharmaceutical company classification were estimated.Results: Twenty-six new, possibly suicidal events (behavior and ideation) that were not originally identified by pharmaceutical companies were identified in the C-CASA, and 12 events originally labeled as suicidal by pharmaceutical companies were eliminated, which resulted in a total of 38 discrepant ratings. For the specific label of "suicide attempt," a relatively low level of agreement was observed between the C-CASA and pharmaceutical company ratings, with the C-CASA reporting a 50% reduction in ratings. Thus, although the C-CASA resulted in the identification of more suicidal events overall, fewer events were classified as suicide attempts. Additionally, the C-CASA ratings were highly reliable (intraclass correlation coefficient [ICC]=0.89).Conclusions: Utilizing a methodical, anchored approach to categorizing suicidality provides an accurate and comprehensive identification of suicidal events. The FDA's audit of the C-CASA demonstrated excellent transportability of this approach. The Columbia algorithm was used to classify suicidal adverse events in the recent FDA adult antidepressant safety analyses and has also been mandated to be applied to all anticonvulsant trials and other centrally acting agents and nonpsychotropic drugs.