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 ] 22 Jill Harkavy-Friedman of the American Foundation for Suicide Prevention in the design of the survey and preparation of this m anuscript and of ISCTM staff members Carlotta McKee and Mary Bea Harding in the conduct of the survey and operational support in preparation of the manuscript. 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 Guidance for Industry: Suicidality: Prospective Assessment of Occurrence in Clinical Trials, Draft Guidance.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. 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 Guidance for Industry: Suicidality: Prospective Assessment of Occurrence in Clinical Trials, Draft Guidance.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. 3. Stewart M, Butler A, Alphs L, et al. Study site experiences and attitudes towards prospective assessments of suicidal ideation and behavior in clinical trials: Results of an internet-based survey. Innov Clin Neurosci. 2013;10(5–6 Suppl A):20S–28S 4. Posner K, Oquendo MA, 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. 2007;164:1035–1043 5. Posner KP, 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 6. Mundt JC, Greist JH, Gelenberg AJ, et al. Feasibility and validation of a computer-automated Columbia- Suicide Severity Rating Scale using interactive voice response technology. J Psych Res. 2010; 44(16): 1224–1228. 7. Mundt JC, Greist JH, Jefferson JW, et al. Prediction of suicidal behavior in clinical research by lifetime suicidal ideation and behavior ascertained by the electronic Columbia-Suicide Severity Rating Scale. J Clin Psychiatry. 2013;74(9):887–93. 8. Coric V, Stock EG, Pultz J, et al. Sheehan Suicidality Tracking Scale (S–STS): Preliminary results from a multicenter clinical trial in generalized anxiety disorder. Psychiatry (Edgmont). 2009;6(1):26–31. 9. Lindenmayer JP, Czobor P, Alphs L, et al, InterSePT Study Group. The InterSePT Scale for Suicidal Thinking reliability and validity. Schizophr Res. 2003; 63:161–70. 10. Sheehan DV, Lecrubier Y, Sheehan KH, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22–33. 11. Hamilton M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 ;23:56–62. 12. Montgomery SA, Asberg M. A new depression scale designed to be sensitive to change. Br J Psychiatry. 1979;134:382–9. 13. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: Validity of a brief depression severity measure. J Gen Intern Med. 2001;16(9):606–13. 14. Rush AJ, Giles DE, Schlesser MA, et al. The Inventory for Depressive Symptomatology (IDS): preliminary findings. Psychiatry Res. 1986;18(1):65–87. 15. Poznanski EO, Grossman JA, Buchsbaum Y, et al. Preliminary studies of the reliability and validity of the Children's Depression Rating Scale. J Am Acad Child Psychiatry. 1984;23(2):191–7. 16. Columbia University Medical Center. Center for Suicide Assessment. Columbia-Suicide Severity Rating Scale (C-SSRS). http://www.cssrs.columbia.edu/scal es_cssrs.html. Accessed October 8, 2014. 17. Reynolds WM. Psychometric characteristics of the Adult Suicidal Ideation Questionnaire in college students. J Pers Assess. 1991;56(2):289–307. 18. Gassman-Mayer C, Jiang K, McSorley P, et al. Clinical and statistical assessment of suicidal ideation and behavior in pharmaceutical trials. Clin Pharmacol Ther. 2011;90(4):554–560.

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