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 173 large percentage of the time this subject experienced suicidality. When these two timeframes were aggregated, more than half of the s ubject's time spent experiencing suicidality fell into the suicidal ideation combinations not captured by the Food and Drug Administration's classification system and the Columbia–Suicide Severity Rating Scale categories. Conclusion: This case study suggests that type II errors in the Food and Drug Administration's classification system and in the Columbia–Suicide Severity Rating Scale categories for suicidal ideation may represent important omissions. INTRODUCTION In 2010, the United States Food and Drug Administration (FDA) issued a draft guidance document on the prospective assessment of suicidal ideation and behavior in drug trials. 1 It recommended using the Columbia Classification Algorithm for Suicide Assessment (C-CASA) 2 "as the standard for coding suicidality data." 1 The C-CASA contains a total of nine categories (4 categories viewed as suicidal, 3 as indeterminate, and 2 as non- suicidal). 2 This draft guidance was updated in August of 2012 3 by replacing the nine-category C-CASA with a "set of 11 preferred categories" to prospectively capture events of suicidality. 3 These 11 preferred categories (referred to as the FDA- CASA 2012) are divided into five categories of suicidal ideation, five categories of suicidal behavior, and the category self-injurious behavior without suicidal intent. 3 The five recognized categories of ideation are linked to the presence or absence of passive ideation, active ideation, a method, intent, or a plan. These categories, however, do not represent all combinations. As shown in Table 1, there are a total of 32 possible combinations of passive ideation, active ideation, method, intent, and plan (2 response options to the power of 5 domains=32). The FDA-CASA 2012 and Columbia–Suicide Severity Rating Scale (C–SSRS) 4 categories are both limited to six of these 32 c ombinations (i.e., the 5 identified combinations plus the null of the 5). The null is the possible combination number 1 in Table 1. The purpose of the following case report is to investigate the possible impact of the type II errors in omitting 26 combinations of passive ideation, active ideation, method, intent, and plan. METHODS A 30-year-old female subject who experienced suicidality almost daily for more than 20 years collected detailed daily data on her events of suicidality. Her first psychiatric diagnosis at age 12 was major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Third Edition, Revised [DSM-III-R]). 5 Four years later, her diagnosis changed to bipolar II disorder (DSM, fourth edition, text revision [DMS-IV-TR]). 6 In 2010, her previous diagnoses were replaced by pervasive developmental disorder, not otherwise specified (PDD- NOS)(DSM IV-TR). 6 Her presentation met criteria for Asperger syndrome in the International Classification of Diseases, 10th Edition (ICD-10). 7 She was very organized, had a very high level of attention to detail, and was highly intelligent by IQ. She reported that her symptoms previously interpreted as hypomania were more closely related to stress from and/or difficulties with communication, being distracted by various stimuli, and periods of excessive focus on topics of interest. All of these are common characteristics found in persons with PPD and Asperger syndrome. The daily documentation included the possible combination number for each event (as illustrated in Table 1), the amount of time spent experiencing the event, and the number of times the event occurred in the prior day (12:00 am through 11:59 pm). Suicidality was defined as any of the suicidal phenomena captured by page 1 of the 11/12/13 version of the Sheehan-Suicidality T racking Scale (S-STS), 8 w ith the exception of non-suicidal self-injury. For the first set of data, she documented her suicidality events for the prior day every morning for a total of 19,854 events of suicidality over a span of 243 consecutive days (8 months) in a spreadsheet. In this data set, 19,853 of the events contained only suicidal ideation, method, intent, and/or plan. In this data set, there were a total of three events that occurred across two distinct days (i.e., they started before midnight one night and finished after midnight the following morning). For the purposes of tracking, each part of an event that spanned across two days was counted as a separate event, with one occurring on the first day and another on the second day. For the second set of data, she documented her suicidality events in a second spreadsheet over the ensuing 274 consecutive days (9 months) for the prior day every morning for a total of 21,210 events of suicidality. In this data set, 21,186 of the events contained only suicidal ideation, method, intent, and/or plan. In this data set, there were a total of two events that occurred across two distinct days, and each of these events were counted as two distinct events. The only difference between the data collected during these two timeframes was that, in the first timeframe, events of only passive and/or active suicidal ideation were collected under an aggregate category called suicidal ideation. In contrast, passive and active suicidal ideation categories were disaggregated from one another in the second timeframe. Passive suicidal ideation was defined as a positive response (>0) to the question "How seriously did you think (even momentarily) that you would be better off dead, need to be dead or wish you were dead?" 8 (question 2 on the S-STS) while active suicidal ideation was defined as a 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 ]

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