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Columbia Classification Algorithm of Suicide Assessment (C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk Analysis of Antidepressants
Open accessAbstract
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.
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“The definitions of ideation and behavior were also used in the Columbia Classification Algorithm for Suicide Assessment, commissioned by the U.S. Food and Drug Administration to classify retrospective reports of potentially suicidal adverse events and to provide interpretable data to inform pivotal drug safety questions (29).”
From The Columbia–Suicide Severity Rating Scale: Initial Validity and Internal Consistency Findings From Three Multisite Studies With Adolescents and Adults (2011) · cites this paper as [29]
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Metadata
- Authors
- Posner, K., Oquendo, M. A., Gould, M., Stanley, B., & Davies, M.
- Affiliations
- New York State Psychiatric Institute (US)
- Corresponding author
- Posner, Kelly
- ORCID
- Davies, Mark
- Venue
- American Journal of Psychiatry
- Published
- 2007-07
- Volume
- 164
- Issue
- 7
- Pages
- 1035-1043
- ISSN
- 0002-953X (ISSN-L)
- 1535-7228
- PMC
- PMC3804920
- OpenAlex
- W2138959943
- Cited by
- 1,025
- References
- 31
- Citations by year
- 2026: 29 · 2025: 67 · 2024: 47 · 2023: 60 · 2022: 54 · 2021: 93 · 2020: 68 · 2019: 53 · 2018: 41 · 2017: 51 · 2016: 63 · 2015: 45 · 2014: 69 · 2013: 53 · 2012: 58
- FWCI
- 45.49
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- American Journal of Psychiatry (publishedVersion)
- PubMed (publishedVersion)
- Europe PMC (PubMed Central) (acceptedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institute on Alcohol Abuse and Alcoholism (P20AA015630)
- National Institute of Mental Health (P50MH090964)
- Topics
- Social Sciences › Psychology › Clinical Psychology › Suicide and Self-Harm Studies
- Health Sciences › Medicine › Pharmacology (medical) › Treatment of Major Depression
- Health Sciences › Medicine › Psychiatry and Mental health › Bipolar Disorder and Treatment
- Keywords
- suicidal ideation, suicidal behavior, suicide attempts, antidepressants, pediatric clinical trials, adverse event classification, rating reliability, youth suicidality
- MeSH terms
- Adolescent, Age Factors, Algorithms, Antidepressive Agents, Mental Disorders, Child, Depressive Disorder, Drug Industry, Female, Humans, Legislation, Drug, Male, Terminology as Topic, Placebos, Suicide, Suicide, Attempted, United States, United States Food and Drug Administration, Meta-Analysis as Topic, Reproducibility of Results, Randomized Controlled Trials as Topic, Risk Assessment
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