Generalizing from clinical trial data: A case study. The risk of suicidality among pediatric antidepressant users

Statistics in Medicine

Volumn 27, Issue 11, 2008, Pages 1801-1813

  Greenhouse, Joel B ^a   Kaizar, Eloise E ^b   Kelleher, Kelly ^c   Seltman, Howard ^a   Gardner, William ^c  

^a CARNEGIE MELLON UNIVERSITY   (United States)

^b OHIO STATE UNIVERSITY   (United States)

^c THE RESEARCH INSTITUTE AT NATIONWIDE CHILDREN S HOSPITAL   (United States)

Author keywords

External validity; FDA; Generalizability bias; Meta analysis; Randomized controlled clinical trials; Youth Risk Behavior Survey

Indexed keywords

ANTIDEPRESSANT AGENT; CITALOPRAM; FLUOXETINE; MIRTAZAPINE; NEFAZODONE; PAROXETINE; PLACEBO; SEROTONIN UPTAKE INHIBITOR; SERTRALINE; VENLAFAXINE;

AGE DISTRIBUTION; ARTICLE; CHILD PSYCHIATRY; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; DATA COLLECTION METHOD; DEMOGRAPHY; ETHNIC DIFFERENCE; HIGH RISK PATIENT; HUMAN; MAJOR DEPRESSION; META ANALYSIS; METHODOLOGY; OUTCOMES RESEARCH; RANDOMIZED CONTROLLED TRIAL; RISK ASSESSMENT; SCREENING TEST; SENSITIVITY ANALYSIS; SEX RATIO; SUICIDAL BEHAVIOR; SUICIDAL IDEATION; SYSTEMATIC REVIEW; VALIDITY;

ADOLESCENT; ANTIDEPRESSIVE AGENTS; CHILD; FEMALE; HUMANS; MALE; META-ANALYSIS AS TOPIC; PEDIATRICS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS; SUICIDE;

EID: 42949164448     PISSN: 02776715     EISSN: 10970258     Source Type: Journal    
DOI: 10.1002/sim.3218     Document Type: Article

References (32)

1. Committee on the Assessment of the US Drug Safety System, Board on Population Health and Public Health Practice. The Future of Drug Safety: Promoting and Protesting the Health of the Public, Baciu A, Stratton K, Burke S (eds). National Academy Press: Washington, DC, 2007.
2. Rothwell PM. Treating individuals 1: external validity of randomised controlled trials: to whom do the results of this trial apply. Lancet 2005; 365:82-93.
3. Tunis SR, Stryer DB, Clancy CM. Practical clinical trials: increasing the value of clinical research for decision making in clinical and health policy. Journal of the American Medical Association 2003; 290(12):1624-1632.
4. Altman D, Schultz K, Moher D, Egger M, Davidoff E, Elbourne D, Altman DG, Schultz KF, Moher D, Egger M, Davidoff F, Elbourne D, Getzsche PC, Lang T. The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Annals of Internal Medicine 2001; 134:663-694.
5. Delate T, Gelenberg AJ, Simmons VA, Motheral BR. Trends in the use of antidepressants in a national sample of commercially insured pediatric patients, 1998 to 2002. Psychiatric Services 2004; 55(4):387-391.
6. Libby A, Brent D, Morrato E, Orton H, Allen R, Valuck R. Decline in treatment of pediatric depression after FDA advisory on risk of suicidality with SSRIs. American Journal of Psychiatry 2007; 164:884-891.
7. Nemeroff C, Kalalil A, Keller M, Charney D, Lenderts S, Cascade E, Nemeroff CB, Kalalil A, Keller MB, Charney DS, Lenderts SE, Cascade EF, Stephenson H, Schatzberg AF. Impact of publicity concerning pediatric suicidality data on physician practice patterns in the United States. Archives of General Psychiatry 2007; 64:466-472.
8. Hamilton B, Miniño A, Martin J, Kochanek K, Strobino D, Guyer B. Annual summary of vital statistics: 2005. Pediatrics 2007; 119:345-360.
9. Valuck RJ, Libby AM, Sills MR, Giese AA, Allen RR. Antidepressant treatment and risk of suicide attempt by adolescents with major depressive disorder: a propensity-adjusted retrospective cohort study. CNS Drugs 2004; 18(15):1119-1132.
10. Simon GE, Savarino J, Operskalski B, Wang PS. Suicide risk during antidepressant treatment. American Journal of Psychiatry 2006; 163(1):41-47.
11. Gibbons RD, Hur K, Bhawnik DK, Mann JJ. The relationship between antidepressant medication use and rate of suicide. Archives of General Psychiatry 2005; 62:165-172.
12. Gibbons RD, Hur K, Bhaunik DK, Mann JJ. The relationship between antidepressant prescription rates and rate of early adolescent suicide. American Journal of Psychiatry 2006; 163:1898-1904.
13. Kaizar EE, Greenhouse JB, Seltman H, Kelleher K. Do antidepressants cause suicidality in children? A Bayesian meta-analysis. Clinical Trials: Journal of the Society for Clinical Trials 2006; 3(2):73-90.
14. Hammad TA. Review and Evaluation of Clinical Data, 2004. Available from: http://www.fda.gov/ohrms/dockets/ac/04/briefing/ 2004-4065b1-10-TAB08-Ha%mmads-Review.pdf [Last accessed 10 June 2005].
15. Hammad TA, Laughren T, Racoosin J. Suicidality in pediatric patients treated with antidepressant drugs. Archives of General Psychiatry 2006; 63:332-339.
16. Longford NT. Selection bias and treatment heterogeneity in clinical trials. Statistics in Medicine 1999; 18(12): 1467-1474.
17. Stevens J, Kelleher K, Greenhouse J, Chen G, Xiang H, Kaizar E, Stevens J, Kelleher K, Greenhouse J, Chen G, Xiang H, Kaizar EE, Jensen PS, Arnold LE. Empirical evaluation of the generalizability of the sample from the Multimodal Treatment Study for ADHD. Administration and Policy in Mental Health 2006; 34:221-232.
18. Hammad TA. Results of the Analysis of Suicidality in Pediatric Trials of Newer Antidepressants, 2004. Available from: http://www.fda.gov/ohrms/ dockets/ac/04/slides/2004-4065S1_08-FDA-Hammad%.ppt [Last accessed 10 June 2005].
19. Centers for Disease Control and Prevention. Methodology of the Youth Risk Behavior Surveillance System. Morbidity and Mortality Weekly Report 2004; 53(RR-12):1-16.
20. Lohr SL. Sampling: Design and Analysis. Duxbury Press: Pacific Grove, CA, 1999.
21. Leslie LK, Newman TB, Chesney PJ, Perrin JM. The food and drug administration's deliberations on antidepressant use in pediatric patients. Pediatrics 2005; 116:195-204.
22. Spitzer R, Williams J, Gibbon M, First M. Structured Clinical Interview for DSM-III-R, Patient Edition/Non-patient Edition, (SCID-P/ SCID-NP). American Psychiatric Press Inc.: Washington, DC, 1990.
23. Kessler RC, Foster CL, Saunders WB, Stang PE. Social consequences of psychiatric disorders. I: educational attainment. American Journal of Psychiatry 1995; 152(7):1026-1032.
24. Gibbons R, Brown H, Hur K, Marcus S, Bhaunik D, Erkens J, Gibbons RD, Brown HC, Hur K, Marcus SM, Bhaunik DK, Erkens JA, Herings RMC, Mann JJ. Early evidence on the effects of regulators' suicidality warnings on SSRI prescriptions and suicide in children and adolescents. American Journal of Psychiatry 2007; 164(9):1356-1363.
25. Simon G, Savarino J. Suicide attempts among patients starting depression treatment with medications or psychotherapy. American Journal of Psychiatry 2007; 164:1029-1034.
26. Gibbons R, Brown H, Hur K, Marcus S, Bhaunik D, Mann J. Relationship between antidepressants and suicide attempts: an analysis of the veterans health administrative data sets. American Journal of Psychiatry 2007; 164(7):1044-1049.
27. Greenhouse JB, Kelleher KJ. Thinking outside the (black) box: antidepressants, suicidality, and research synthesis. Pediatrics 2005; 116:231-233.
28. Simon G. How can we know whether antidepressants increase suicide risk? American Journal of Psychiatry 2006; 163:1861-1862.
29. Zimmerman M, Chelminski I, Posternak M. Generalizability of antidepressant efficacy trials: differences between depressed psychiatric outpatients who would or would not qualify for an efficacy trial. American Journal of Psychiatry 2005; 162:1370-1372.
30. Klein D. The flawed basis for FDA post-marketing safety decisions: the example of anti-depressants and children. Neuropsychopharmacology 2006; 31:689-699.
31. Bridge J, Iyengar S, Salary C, Barbe R, Birmaher B, Pincus H, Bridge JA, Iyengar S, Salary CB, Barbe RP, Birmaher B, Pincus HA, Ren L, Brent DA. Clinical response and risk for reported suicidal ideation and suicide attempts in pediatric antidepressant treatment: a meta-analysis of randomized clinical trials. Journal of the American Medical Association 2007; 297:1683-1696.
32. Committee on Pathophysiology and Prevention of Adolescent and Adult Suicide, Board on Neuroscience and Behavioral Health. Reducing Suicide: A National Imperative, Goldsmith S, Pellmar T, Kleinman A, Bunney W (eds). National Academy Press: Washington, DC, 2002.