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 ] 178 2007;164(7):1035–1043. 3. 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 Guidance for Industry: Suicidality: Prospective Assessment of Occurrence in Clinical Trials, Draft Guidance.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/Drug s/Guidances/UCM225130.pdf. Accessed October 1, 2014. 4. 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. 5. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Third edition, Revised. Washington, DC: American Psychiatric Press Inc.; 1987. 6. American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision. Washington, DC: American Psychiatric Association; 2000. 7. World Health Organization. ICD-10 Classifications of Mental and Behavioural Disorder: Clinical Descriptions and Diagnostic Guidelines. Geneva. World Health Organization; 2010. 8. Sheehan DV, Giddens JM, Sheehan IS. Status update on the Sheehan Suicidality Tracking Scale (S-STS). Innov Clin Neurosci. 2014;11(9–10):93–140. TABLE 5. Set 2: Suicidality not captured by FDA-CASA 2012 and C–SSRS Categories Suicidality Set 2 (9 Months) Not Captured by FDA-CASA 2012 Not Captured by C–SSRS T otal number of events 4,256 4,256 Total number of minutes 17,785.4 17,785.4 % of total events 20.06 20.06 % of total minutes 59.67 59.67 FDA-CASA 2012: United States Food and Drug Administration-Classification Algorithm for Suicide Assessment; C–SSRS: Columbia–Suicide Severity Rating Scale TABLE 6. Suicidality not captured by FDA-CASA 2012 and C–SSRS Categories over a period of 17 Months Suicidality Set 1 (8 Months) Set 2 (9 Months) 17 Months Not Captured by FDA-CASA 2012* Not Captured by C–SSRS* Not Captured by FDA-CASA 2012 Not Captured by C–SSRS Total Not Captured by FDA-CASA 2012* Total Not Captured by C–SSRS* Total number of events 1,040 1,040 4,256 4,256 5,296 5,296 Total number of minutes 9,763.4 9,763.4 17,785.4 17,785.4 27,548.8 27,548.8 % of total events 5.19 5.19 20.06 20.06 12.90 12.90 % of total minutes 40.14 40.14 59.67 59.67 50.94 50.94 * 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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