Current Assessment and Classification of Suicidal Phenomena using the FDA 2012 Draft Guidance Document on Suicide Assessment: A Critical Review

Innovations in Clinical Neuroscience

Jennifer M. Giddens¹  Kathy Harnett Sheehan¹  David V. Sheehan¹ 

[1] Dr. D. Sheehan is Distinguished University Health Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida; J. Giddens is the Co-founder of the Tampa Center for Research on Suicidality, Tampa, Florida; and Dr. K. Sheehan is Associate Professor Emeritus at the University of South Florida College of Medicine, Tampa, Florida.

关键词: Suicide scale;    suicide assessment;    suicide risk;    suicide attempt;    suicide;    suicidal ideation;    suicidal behavior;    suicidality;    C-SSRS;    FDA 2012 Draft Guidance Document;    suicidal classification;   

DOI  :  

学科分类：精神健康和精神病学

来源: Matrix Medical Communications, LLC

【 摘 要 】

Objective: Standard international classification criteria require that classification categories be comprehensive to avoid type II error. Categories should be mutually exclusive and definitions should be clear and unambiguous (to avoid type I and type II errors). In addition, the classification system should be robust enough to last over time and provide comparability between data collections. This article was designed to evaluate the extent to which the classification system contained in the United States Food and Drug Administration 2012 Draft Guidance for the prospective assessment and classification of suicidal ideation and behavior in clinical trials meets these criteria.

【 授权许可】

Unknown