Innovations In Clinical Neuroscience

SEP-OCT 2014

A peer-reviewed, evidence-based journal for clinicians in the field of neuroscience

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[ V O L U M E 1 1 , N U M B E R 9 – 1 0 , S E P T E M B E R – O C T O B E R 2 0 1 4 ] Innovations in CLINICAL NEUROSCIENCE 75 T ABLE 3. Mismatches between C–SSRS and FDA-CASA 2012 C–SSRS Title FDA-CASA 2012 Title C–SSRS and FDA-CASA 2 012 Titles Match? C–SSRS and FDA-CASA 2 012 Definitions Match? C–SSRS Probe Consistent? SUICIDAL IDEATION "Wish to be Dead" "Passive suicidal ideation: wish to be dead" Partially 1 Yes Partially 1 "Non-Specific Active Suicidal T houghts" "Active suicidal ideation: non-specific ( no method, intent: or plan)" Partially 2 Yes No 2 "Active Suicidal Ideation with Any Methods (Not Plan) Without Intent t o Act" "Active suicidal ideation: method but no intent or plan" Yes Yes No 3 "Active Suicidal Ideation With Some Intent to Act, Without Specific Plan" "Active suicidal ideation: method and intent, but no plan" No 4 Yes No 4 "Active Suicidal Ideation with Specific Plan and Intent" "Active suicidal ideation: method, intent, and plan" No 5 Yes No 5 SUICIDAL BEHAVIOR "Actual Attempt" "Suicide attempt" Yes Yes 6 No 6 "Interrupted Attempt" "Interrupted suicide attempt" Yes Yes Yes "Aborted Attempt" "Aborted suicide attempt" Mostly 7 Yes Yes "Preparatory Acts or Behavior" "Preparatory acts toward imminent suicidal behaviors" No 8 No 8 No "Suicide" "Completed suicide" Yes 9 No definition No probe "Non-Suicidal Self-Injurious Behavior" "Self-injurious behavior without suicidal intent" No No No 1 The C–SSRS title does not contain the FDA concept of "passive ideation." The probe does not have any reference to a wish to not be alive.*,** 2 The C–SSRS title omits the FDA reference to "no method, intent or plan." While the definition is consistent, the probe is ambiguous. It could refer to specific or non-specific thoughts.*,** 3 The C–SSRS probe only asks a "how" (method) question. It could elicit an answer that is inconsistent with the FDA category since it does not specify no intent or plan.*,** 4 The C–SSRS title is inconsistent with the FDA title in that it does not mention the requirement of a "method." The C–SSRS probe also fails to address the method requirement. In addition, instead of requiring there be "no plan," the C–SSRS requires no "specific" plan. This narrows the concept of a "plan."*,** 5 Again, the C–SSRS title is inconsistent with the FDA title in that it does not mention the requirement of a "method." It also differs from the FDA-CASA 2012 in requiring a "specific" plan. Further the probe suggests that it is enough for the patient to have "started" to work out details of a plan, a broader window than that conveyed in the C–SSRS and FDA CASA definitions, which require details "fully or partially" worked out.*,** 6 Definitions are generally similar although C–SSRS definition is much wordier. Probe questions with open-ended answers could elicit a suicide attempt or non-suicidal self-injurious behavior.*,** 7 The C–SSRS uses "Self-Interrupted" as well as "Aborted" title whereas the FDA-CASA 2012 only uses "Aborted."*,** 8 The C–SSRS differs from the FDA-CASA 2012 in not adding "imminent" as a qualifier in the title although the C–SSRS does add this qualifier in its definition. The C–SSRS definition is more expansive than that provided by the FDA-CASA 2012 since it does not indicate that such behaviors need to stop short of a suicide attempt, an interrupted suicide attempt, or an aborted suicide attempt.*,** 9 This category is only present on the C–SSRS "Since Last Visit" Version. The title "Suicide" is not consistent with the FDA-CASA 2012 title "Completed suicide" in that the word on its own could be interpreted to mean completed or not completed. Unlike the FDA-CASA 2012, the C–SSRS does not provide a definition for this category.*,** * United States Food and Drug Administration, United States Department of Health and Human Services. Guidance for Industry: Suicidality: Prospective Assessment of Occurrence in Clinical Trials, Draft Guidance. August 2012. Revision 1. http://www.fda.gov/downloads/Drugs/Guidances/ UCM225130.pdf. Accessed October 1, 2014. ** Posner K, Brown GK, Stanley B, et.al. The Columbia–Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011;168:1266–1277. C–SSRS: Columbia–Suicide Severity Rating Scale; FDA-CASA 2012: United States Food and Drug Administration-Classification Algorithm for Suicide Assessment

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