Columbia Classification Algorithm of Suicide Assessment (C-CASA): Classification of Suicidal Events in the FDA’s Pediatric Suicidal Risk Analysis of Antidepressants

Abstract

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.

A Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of 2 Doses of Vortioxetine in Adults With Major Depressive Disorder

“…Electrocardiograms (ECGs) and laboratory tests were measured at baseline and weeks 4 and 8, and physical examinations were performed at screening and week 8. Suicidal ideation and behavior were prospectively monitored using the Columbia-Suicide Severity Rating Scale (C-SSRS), 22 which was administered at screening, baseline, and weeks 1, 2, 4, 6, and 8. The Arizona Sexual Experience Scale (ASEX), 23 a validated 5-item scale with versions specific to gender and sexual orientation, was used to assess the impact of treatment on sexual function.…”

Understanding the Relationship between Substance Use and Self-Injury in American Indian Youth

“…Definitions of events for completing the suicide registry form and validation process are modeled on the Columbia Classification Algorithm for Suicide Assessment (C-CASA) (7). A suicide is defined as a death resulting from intentional self-inflicted injury as determined by the local medical examiner or authorized law enforcement official.…”

Coding of adverse events of suicidality in clinical study reports of duloxetine for the treatment of major depressive disorder: descriptive study

“…The box describes each data format, and Search terms included those that the FDA requested pharmaceutical companies to use when searching company databases for events of suicidality in paediatric trials ("suic", "overdos, "attempt", "cut", "gas", "hang", "hung", "jump", "mutilate", "overdos", "self damage", "self harm", "self inflict", "self injur", "shoot", and "slash"). 15 22 We additionally used the terms "poi", "emot", "labi", "hos", "vio", "agg", "thought", and "think". We were only interested in adverse events that met the definition in the international statistical principles for clinical trials guideline of a treatment emergent adverse event-that is, an event that occurred or worsened after the study drug was started, 23 or adverse events that emerged after discontinuation of the study drug.…”

“…The FDA found that any conclusion based on such data would be unreliable and might lead to either an unwarranted restriction of the drugs or an underestimation of their dangers. 15 Unsurprisingly, research in other areas has shown that misclassifying or omitting even one adverse event can mean the difference between a statistically significant and non-statistically significant association with a drug. 16 17 We assessed the effects of coding and coding conventions on adverse events data within clinical study reports and compared three different data formats.…”