Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants.
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-...
| Publicado en: | American Journal of Psychiatry Vol. 164; no. 7; pp. 1035 - 1044 |
|---|---|
| Autores principales: | , , , , , , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
American Psychiatric Publishing, Inc.
Jul2007
|
| Acceso en línea: | Ver este registro en EBSCOhost |
| fields | @attributes: recordID: 1 pdfLink: plink: https://search.ebscohost.com/login.aspx?direct=true&db=ccm&AN=106201551&site=ehost-live header: @attributes: shortDbName: ccm uiTerm: 106201551 longDbName: CINAHL Complete uiTag: AN controlInfo: bkinfo: dissinfo: jinfo: jid: 0002953X API jtl: American Journal of Psychiatry issn: 0002953X maglogo: N pubinfo: dt: Jul2007 vid: 164 iid: 7 pid: 37323 pub: American Psychiatric Publishing, Inc. place: Arlington, Virginia artinfo: ui: 106201551 106201551 NLM17606655 2009624402 10.1176/ajp.2007.164.7.1035 NLM17606655 PMC3804920 106201551 ppf: 1035 ppct: 9 formats: tig: atl: Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. aug: au: Posner K Oquendo MA Gould M Stanley B Davies M Posner, Kelly Oquendo, Maria A Gould, Madelyn Stanley, Barbara Davies, Mark affil: Division of Child and Adolescent Psychiatry, Columbia University/New York State Psychiatric Institute, New York, NY 10032, USA sug: subj: Algorithms Antidepressive Agents Adverse Effects Risk Assessment Suicide Classification United States Food and Drug Administration Adolescence Age Factors Antidepressive Agents Therapeutic Use Child Depression Drug Therapy Depression Psychosocial Factors Descriptive Statistics Female Funding Source Intraclass Correlation Coefficient Legislation, Drug Male Mental Disorders Drug Therapy Mental Disorders Psychosocial Factors Meta Analysis Nomenclature Pharmaceutical Companies Placebos Reproducibility of Results Risk Assessment Methods Suicide Psychosocial Factors Suicide, Attempted Classification Suicide, Attempted Psychosocial Factors United States Human Adolescent: 13-18 years Child: 6-12 years Female Male ab: 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. pubtype: Academic Journal doctype: research tables/charts Journal Article ougenre: Article language: English refInfo: holdings: @attributes: islocal: N |
|---|