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-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).


METHODS
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.
Posner
Kelly
K
Division of Child and Adolescent Psychiatry, Columbia University/New York State Psychiatric Institute, New York, NY 10032, USA. posnerk@childpsych.columbia.edu
Oquendo
Maria A
MA
Gould
Madelyn
M
Stanley
Barbara
B
Davies
Mark
M
D000293:Adolescent; D000367:Age Factors; D000465:Algorithms; D000928:Antidepressive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D003866:Depressive Disorder / Q000188:drug therapy / Q000523:psychology; D004345:Drug Industry / Q000706:statistics & numerical data; D005260:Female; D006801:Humans; D007880:Legislation, Drug; D008297:Male; D001523:Mental Disorders / Q000188:drug therapy / Q000523:psychology; D015201:Meta-Analysis as Topic; D010919:Placebos; D016032:Randomized Controlled Trials as Topic / Q000706:statistics & numerical data; D015203:Reproducibility of Results; D018570:Risk Assessment / Q000379:methods / Q000706:statistics & numerical data*; D013405:Suicide / Q000145:classification* / Q000523:psychology / Q000706:statistics & numerical data; D013406:Suicide, Attempted / Q000145:classification / Q000523:psychology / Q000706:statistics & numerical data; D009626:Terminology as Topic; D014481:United States; D014486:United States Food and Drug Administration / Q000706:statistics & numerical data*
D000928:Antidepressive Agents; D010919:Placebos