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 59 know that passive and active types of ideation often coexist. For example, a daydream about shooting oneself can convert to passive ideation (where t he subject wishes to be dead) and back again to active ideation (shooting oneself) in seconds; and 2) There is no evidence that patients always follow these escalating steps or that more features necessarily means more severity. In some cases, the patient with a violent method but no intent or plan may be at greater risk than one with method, intent, and plan. 13 Third, an assumption is made that method, intent, and plan do not exist independent of ideation when in fact patients do report having a method, plan, or even intent quite independent of ideation, active or passive. Not considering this group is a potential safety issue. Fourth, an assumption is made that the definition of plan includes intent and, as clarified in a footnote on page 4 of the FDA 2012 Draft Guidance, "thus, there is no need for the category method and plan, but no intent." 4 This assumption is problematic because patients sometimes make detailed plans years in advance. To dismiss the existence of a plan—since the subject has no current intent—and place the subject at the same level as someone who endorses active ideation without intent or plan poses a relative safety issue. The existence of a plan could well make this person much more vulnerable than someone without a plan. Fifth, the assumption is made (presumably based on the C–SSRS) that reporting of ideation should be anchored only in events to the exclusion of time spent enduring such events. This is problematic since a patient could present in two different time frames with the same number of events in the same categories but show a dramatic increase in the amount of time spent in suicidal ideation or behavior. For example, one case study found evidence of as much as a 26-fold increase in time spent in suicidal FIGURE 1. Distribution of suicidality events from suicidal subject's diary over 9 months Note: Total number of days of data collection: 274; total number of suicidality events: 21,210. Overall, the FDA-CASA 2012 misses the combinations experienced in 4,256 events of suicidality (20.06% of all such events) FDA: United States Food and Drug Administration; C–SSRS: Columbia–Suicide Severity Rating Scale FIGURE 2. Distribution of time spent in suicidality from suicidal subject's diary over 9 months Note: Total number of days of data collection: 274; total number of minutes with suicidality: 29,804. Overall, the FDA-CASA 2012 misses the combinations experienced over 17,785.4 minutes (296 hours, 25 minutes and 24 seconds) of suicidality (59.67% of minutes) FDA: United States Food and Drug Administration; C–SSRS: Columbia–Suicide Severity Rating Scale

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