CNS Clinical Trials: Suicidality and Data Collection: Workshop Summary (2010)

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A References Anguelova, M., C. Benkelfat, and G. Turecki. 2003. A systematic review of association studies investigating genes coding for serotonin receptors and the serotonin transporter: II. Suicidal behavior. Mol Psychiatry 8(7):646–653. Beck, A. T., G. K. Brown, and R. A. Steer. 1997. Psychometric characteristics of the scale for suicide ideation with psychiatric outpatients. Behav Res Ther 35(11):1039–1046. Beck, A. T., G. K. Brown, R. A. Steer, K. K. Dahlsgaard, and J. R. Grisham. 1999. Suicide ideation at its worst point: A predictor of eventual suicide in psychiatric outpatients. Suicide Life Threat Behav 29(1):1–9. Bridge, J. A., R. P. Barbe, B. Birmaher, D. J. Kolko, and D. A. Brent. 2005. Emergent suicidality in a clinical psychotherapy trial for adolescent depression. Am J Psychiatry 162(11):2173–2175. Bridge, J. A., J. B. Greenhouse, A. H. Weldon, J. V. Campo, and K. J. Kelleher. 2008. Suicide trends among youths aged 10 to 19 years in the United States, 1996–2005. JAMA 300(9):1025–1026. 43 

44 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION Bridge, J. A., S. Iyengar, C. B. Salary, R. P. Barbe, B. Birmaher, H. A. Pincus, L. Ren, and D. A. Brent. 2007. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: A meta-analysis of randomized controlled trials. JAMA 297(15):1683–1696. Brown, G. K., T. Ten Have, G. R. Henriques, S. X. Xie, J. E. Hollander, and A. T. Beck. 2005. Cognitive therapy for the prevention of suicide attempts: A randomized controlled trial. JAMA 294(5):563–570. Buckman, S. 2009. Ways to facilitate collaboration: How and who? Presentation at the IOM Workshop on CNS Clinical Trials: Suicidality and Data Collection, Washington, DC, June 16. Cavanagh, J. T., A. J. Carson, M. Sharpe, and S. M. Lawrie. 2003. Psychological autopsy studies of suicide: A systematic review. Psychol Med 33(3):395–405. CDC (Centers for Disease Control and Prevention). 2006. Suicide injury deaths and rates per 100,000. http://www.cdc.gov/injury/wisqars/ index.html (accessed December 10, 2009). Currier, D., and J. J. Mann. 2008. Stress, genes and the biology of suicidal behavior. Psychiatr Clin North Am 31(2):247–269. Damasio, H., T. Grabowski, R. Frank, A. M. Galaburda, and A. R. Damasio. 1994. The return of Phineas Gage: Clues about the brain from the skull of a famous patient. Science 264(5162):1102–1105. Engel, G. L. 1978. The biopsychosocial model and the education of health professionals. Ann N Y Acad Sci 310:169–187. Fawcett, J., D. C. Clark, and W. A. Scheftner. 1991. The assessment and management of the suicidal patient. Psychiatr Med 9(2):299– 311. FDA (Food and Drug Administration). 2007. Questions and answers on antidepressant use in children, adolescents, and adults: May, 2007. http://www.fda.gov/Drugs/DrugSafety/InformationbyDrug Class/ucm096321.htm (accessed December 10, 2009). Fombonne, E., G. Wostear, V. Cooper, R. Harrington, and M. Rutter. 2001. The Maudsley long-term follow-up of child and adolescent depression. 2. Suicidality, criminality and social dysfunction in adulthood. Br J Psychiatry 179:218–223. Galfalvy, H., Y. Y. Huang, M. A. Oquendo, D. Currier, and J. J. Mann. 2009. Increased risk of suicide attempt in mood disorders and tph1 genotype. J Affect Disord 115(3):331–338. 

APPENDIX A 45 Gibbons, R. 2009. CNS clinical trials: Suicidality and data collection. Presentation at the IOM Workshop on CNS Clinical Trials: Suicidality and Data Collection, Washington, DC, June 16. Gibbons, R., and J. J. Mann. 2009. Proper studies of selective serotonin reuptake inhibitors are needed for youth with depression. CMAJ 180(3):270–271. Gibbons, R., C. H. Brown, K. Hur, and J. J. Mann. 2009. Relationship between antiepileptic drugs and suicide attempts in patients with bipolar disorder. Arch Gen Psychiatry 66(12):1354–1360. Gibbons, R. D., C. H. Brown, K. Hur, S. M. Marcus, D. K. Bhaumik, J. A. Erkens, R. M. Herings, and J. J. Mann. 2007. Early evidence on the effects of regulators’ suicidality warnings on SSRI prescriptions and suicide in children and adolescents. Am J Psychiatry 164(9):1356–1363. Goodwin, F., and K. Jamison. 2007. Manic-depressive illness: Biopolar disorders and recurrent depression. 2nd ed. Oxford, UK: Oxford University Press. Greenhouse, J. B., E. E. Kaizar, K. Kelleher, H. Seltman, and W. Gardner. 2008. Generalizing from clinical trial data: A case study. The risk of suicidality among pediatric antidepressant users. Stat Med 27(11):1801–1813. Guzzetta, F., L. Tondo, F. Centorrino, and R. J. Baldessarini. 2007. Lithium treatment reduces suicide risk in recurrent major depressive disorder. J Clin Psychiatry 68(3):380–383. Hammad, T. A., T. Laughren, and J. Racoosin. 2006. Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry 63(3):332–339. Harris, E., and B. Barraclough. 1997. Suicide as an outcome for mental disorders. A meta-analysis. Br J Psychiatry 170:205–228. Heim, C., and C. B. Nemeroff. 2001. The role of childhood trauma in the neurobiology of mood and anxiety disorders: Preclinical and clinical studies. Biol Psychiatry 49(12):1023–1039. Hill, A. B. 1965. The environment and disease: Association or causation? Proc R Soc Med 58:295–300. IOM (Institute of Medicine). 2002. Reducing suicide: A national imper- ative. Washington, DC: The National Academies Press. Kaizar, E. E., J. B. Greenhouse, H. Seltman, and K. Kelleher. 2006. Do antidepressants cause suicidality in children? A Bayesian meta- analysis. Clin Trials 3(2):73–90; discussion 91–98. 

46 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION Keilp, J. G., M. A. Oquendo, B. H. Stanley, A. K. Burke, T. B. Cooper, K. M. Malone, and J. J. Mann. 2008. Future suicide attempt and responses to serotonergic challenge. Neuropsychopharmacology online publication March 19. Knox, K. L., D. A. Litts, G. W. Talcott, J. C. Feig, and E. D. Caine. 2003. Risk of suicide and related adverse outcomes after exposure to a suicide prevention programme in the US Air Force: Cohort study. BMJ 327(7428):1376. Kovacs, M., D. Goldston, and C. Gatsonis. 1993. Suicidal behaviors and childhood-onset depressive disorders: A longitudinal investigation. J Am Acad Child Adolesc Psychiatry 32(1):8–20. Laughren, T. 2009. Development of Division of Psychiatry Products policy on prospective suicidality assessment in studies conducted under INDs. Presentation at the IOM Workshop on CNS Clinical Trials: Suicidality and Data Collection, Washington, DC, June 16. Lauterbach, E., W. Felber, B. Muller-Oerlinghausen, B. Ahrens, T. Bronisch, T. Meyer, B. Kilb, U. Lewitzka, B. Hawellek, A. Quante, K. Richter, A. Broocks, and F. Hohagen. 2008. Adjunctive lithium treatment in the prevention of suicidal behaviour in depressive disorders: A randomised, placebo-controlled, 1-year trial. Acta Psychiatr Scand 118(6):469–479. Libby, A. M., H. D. Orton, and R. J. Valuck. 2009. Persisting decline in depression treatment after FDA warnings. Arch Gen Psychiatry 66(6):633–639. Little, A. 2009. Treatment-resistant depression. Am Fam Physician 80(2):167–172. Luoma, J. B., C. E. Martin, and J. L. Pearson. 2002. Contact with mental health and primary care providers before suicide: A review of the evidence. Am J Psychiatry 159(6):909–916. Mann, J. J. 2003. Neurobiology of suicidal behaviour. Nat Rev Neurosci 4(10):819–828. Mann, J. J. 2009. Treatment-emergent suicidal events in adolescents: Neurobiologic considerations. Presentation at the IOM Workshop on CNS Clinical Trials: Suicidality and Data Collection, Washington, DC, June 16. Mann, J. J., D. Currier, B. Stanley, M. A. Oquendo, L. V. Amsel, and S. P. Ellis. 2006. Can biological tests assist prediction of suicide in mood disorders? Int J Neuropsychopharmacol 9(4):465–474. 

APPENDIX A 47 MHRA (Medicines and Healthcare Products Regulatory Agency). 2003. Selective serotonin reuptake inhibitor—use in children and adolescents with major depressive disorder. http://www.mhra. gov.uk/home/groups/pl-p/documents/websiteresources/con019492.pdf (accessed January 4, 2010). Moskowitz, D. S., and S. N. Young. 2006. Ecological momentary assessment: What it is and why it is a method of the future in clinical psychopharmacology. J Psychiatry Neurosci 31(1):13– 20. NIMH (National Institute of Mental Health). 2009. Results for Sequenced Treatment Alternatives to Relieve Depression (STAR*D) study. http://www.nimh.nih.gov/health/trials/practical/ stard/index.shtml (accessed December 9, 2009). Nock, M. K., I. Hwang, N. Sampson, R. C. Kessler, M. Angermeyer, A. Beautrais, G. Borges, E. Bromet, R. Bruffaerts, G. de Girolamo, R. de Graaf, S. Florescu, O. Gureje, J. M. Haro, C. Hu, Y. Huang, E. G. Karam, N. Kawakami, V. Kovess, D. Levinson, J. Posada- Villa, R. Sagar, T. Tomov, M. C. Viana, and D. R. Williams. 2009a. Cross-national analysis of the associations among mental disorders and suicidal behavior: Findings from the WHO world mental health surveys. PLoS Med 6(8):e1000123. Nock, M. K., I. Hwang, N. A. Sampson, and R. C. Kessler. 2009b. Mental disorders, comorbidity and suicidal behavior: Results from the National Comorbidity Survey Replication. Mol Psychiatry (March 31, 2009). Olfson, M., S. C. Marcus, and D. Shaffer. 2006. Antidepressant drug therapy and suicide in severely depressed children and adults: A case-control study. Arch Gen Psychiatry 63(8):865–872. Pace, W. D., M. Cifuentes, R. J. Valuck, E. W. Staton, E. C. Brandt, and D. R. West. 2009. An electronic practice-based network for observational comparative effectiveness research. Ann Intern Med 151(5):338–340. Pandey, G. N., and Y. Dwivedi. 2007. Noradrenergic function in suicide. Arch Suicide Res 11(3):235–246. Posner, K. 2009. C-CASA and C-SSRS in CNS clinical trials: Development and implementation. Presentation at the IOM Workshop on CNS Clinical Trials: Suicidality and Data Collection, Washington, DC, June 16. 

48 CNS CLINICAL TRIALS: SUICIDALITY AND DATA COLLECTION Posner, K., M. A. Oquendo, M. Gould, B. Stanley, and M. Davies. 2007. 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 164(7):1035–1043. Rao, U., M. M. Weissman, J. A. Martin, and R. W. Hammond. 1993. Childhood depression and risk of suicide: A preliminary report of a longitudinal study. J Am Acad Child Adolesc Psychiatry 32(1):21–27. Rush, A. 2009. Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR). http://counsellingresource.com/quizzes/qids- depression/index.html (accessed December 11, 2009). Rutz, W., L. von Knorring, and J. Walinder. 1989. Frequency of suicide on Gotland after systematic postgraduate education of general practitioners. Acta Psychiatr Scand 80(2):151–154. Rutz, W., L. von Knorring, and J. Walinder. 1992. Long-term effects of an educational program for general practitioners given by the Swedish Committee for the Prevention and Treatment of Depression. Acta Psychiatr Scand 85(1):83–88. Sareen, J., B. J. Cox, T. O. Afifi, R. de Graaf, G. J. Asmundson, M. ten Have, and M. B. Stein. 2005. Anxiety disorders and risk for suicidal ideation and suicide attempts: A population-based longitudinal study of adults. Arch Gen Psychiatry 62(11):1249– 1257. Stone, M., T. Laughren, M. L. Jones, M. Levenson, P. C. Holland, A. Hughes, T. A. Hammad, R. Temple, and G. Rochester. 2009. Risk of suicidality in clinical trials of antidepressants in adults: Analysis of proprietary data submitted to U.S. Food and Drug Administration. BMJ 339:b2880. Szanto, K., B. H. Mulsant, P. R. Houck, M. A. Dew, A. Dombrovski, B. G. Pollock, and C. F. Reynolds, III. 2007. Emergence, persistence, and resolution of suicidal ideation during treatment of depression in old age. J Affect Disord 98(1–2):153–161. Valuck, R. J. 2009. Studying suicidality: From RCTs to OCER. Presentation at the IOM Workshop on CNS Clinical Trials: Suicidality and Data Collection, Washington, DC, June 16. Valuck, R. J., H. D. Orton, and A. M. Libby. 2009. Antidepressant discontinuation and risk of suicide attempt: A retrospective, nested case-control study. J Clin Psychiatry 70(8):1069–1077. 

APPENDIX A 49 Weisberg, H. I., V. C. Hayden, and V. P. Pontes. 2009. Selection criteria and generalizability within the counterfactual framework: Explaining the paradox of antidepressant-induced suicidality? Clin Trials 6(2):109–118. Weissman, M. M., S. Wolk, R. B. Goldstein, D. Moreau, P. Adams, S. Greenwald, C. M. Klier, N. D. Ryan, R. E. Dahl, and P. Wickramaratne. 1999. Depressed adolescents grown up. JAMA 281(18):1707–1713. Zisook, S., M. H. Trivedi, D. Warden, B. Lebowitz, M. E. Thase, J. W. Stewart, C. Moutier, M. Fava, S. R. Wisniewski, J. Luther, and A. J. Rush. 2009. Clinical correlates of the worsening or emergence of suicidal ideation during SSRI treatment of depression: An examination of citalopram in the STAR*D study. J Affect Disord 117(1–2):63–73.