Innovations In Clinical Neuroscience

SEP-OCT 2014

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

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Innovations in CLINICAL NEUROSCIENCE [ 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 ] 176 not recognized by the current classification system, possible combination number 18 (only passive and active suicidal ideation), occurred 3,327 times on 274 distinct days and consumed 3,750.6 minutes during the entire nine months. This combination constituted 15.69 percent of the total number of events, 12.58 percent of the number of minutes spent experiencing suicidality, and occurred on 100 percent of the days. Table 5 shows the total number of events, total number of minutes, percentage of events, and percentage of minutes not recognized by the FDA-CASA 2012 and C–SSRS category definitions. Although only 20.06 percent of the events that occurred could not be classified, they represented 59.67 percent of the total minutes (or 17,785.4 minutes) this subject experienced suicidality in this nine- month period. DISCUSSION The data from these two data sets suggest that the combinations missed by the FDA-CASA 2012 and the C–SSRS categories do occur in real world experience. Although they constitute a minority of all events experienced, they consumed a large amount of time spent in suicidality by this subject. Dataset 1 collected "passive and/or active suicidal ideation without method, intent or plan" as one category. Dataset 2 disaggregated this category into combinations 2, 17, and 18. As a result, what are three event combinations in the second dataset are counted as only one category in the first dataset. Combination 18 occurred frequently during the timeframe of the first dataset and cannot be captured as a unique combination by the current FDA- CASA 2012 classification system. When we combined combinations 2, 17, and 18 in the second data set and compared it to this aggregate category in the first data set, the number of events of suicidality, the time spent, and the distribution percentage of suicidality event combinations 2, 17, and 18 in both datasets were very similar. When we compared the two datasets they appeared very similar in most respects. In aggregate, across the combined 17-month period of observation, only 12.9 percent of the events that occurred cannot be classified by the FDA-CASA 2012 and C–SSRS categories. However, these represented 50.94 percent of the total minutes this subject experienced suicidality in this 17-month period (Table 6). The number of events, the number of minutes, the percentage of events, and the percentage of minutes not captured by the FDA- C ASA 2012 and the C–SSRS categories over this 17-month timeframe would likely be higher if the first data set had disaggregated possible combinations 2, 17, and 18. Limitations. The use of only one subject for this case study means these findings may not be generalizable to other cases of suicidality. The study has all the limitations inherent in the interpretation of single case studies. It will need to be replicated in larger, more diverse samples before having confidence in the findings. CONCLUSION The data suggest that the categories recommended in the FDA- CASA 2012 and in the C–SSRS are incomplete in capturing all combinations of passive and active suicidal ideation, method, intent, and plan that occur clinically (26 of 32 are missed/not recognized). Failure to capture all suicidal ideation combinations that constitute over one half of the patient's time spent in suicidality has important public health implications. REFERENCES 1. 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. September 2010. https://www.federalregister.gov/artic les/2010/09/09/2010-22404/draft- guidance-for-industry-on- suicidality-prospective-assessment- of-occurrence-in-clinical-trials. Accessed October 1, 2014. 2. Posner K., Oquendo M., Gould M et al. Columbia Classification Algorithm of Suicide Assessment (C-CASA): classification of suicidal events in the FDA's pediatric suicidal risk analysis of antidepressants. Am J Psychiatry. TABLE 3. Set 1: Suicidality not captured by FDA-CASA 2012 and C–SSRS categories Suicidality Set 1 (8 Months) Not Captured by FDA-CASA 2012* Not Captured by C–SSRS* Total number of events 1,040 1,040 Total number of minutes 9,763.4 9,763.4 % of total events 5.19 5.19 % of total minutes 40.14 40.14 * Actual values likely higher due to lack of disaggregation of possible combination numbers 2, 17, and 18 in Set 1. FDA-CASA 2012: United States Food and Drug Administration-Classification Algorithm for Suicide Assessment; C–SSRS: Columbia–Suicide Severity Rating Scale

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