13
Views
0
CrossRef citations to date
0
Altmetric
Original Article

Suicide Risk and Symptom Reduction in Patients Assigned to Placebo in Duloxetine and Escitalopram Clinical Trials: Analysis of the FDA Summary Basis of Approval Reports

&
Pages 31-36 | Published online: 04 Dec 2011

References

  • Fergusson D, Doucette S, Glass KC, Shapiro S, Healy D, Hebert P. Hutton B: Association between suicide attempts and selective serotonin reuptake inhibitors: Systematic review of randomized controlled trials. BMJ 2005; 330:396
  • Gunnell D, Saperia J, Ashby D: Selective serotonin reuptake inhibitors (SSR1s) and suicide in adults: Meta-analysis of drug company data from placebo controlled, randomized controlled tri-als submitted to the MHRA' s safety review. BMJ 2005; 330:385
  • Grunebaum MF, Ellis SP, Li S, Oquendo MA, Mann JJ: Antide-pressants and suicide risk in the United States, 1985-1999. J Clin Psychiatry 2005; 65:1456–1462
  • Gibbons RD, Hur K, Bhaumik DK, Mann JJ: The relationship between antidepressant medication use and rate of suicide. Arch Gen Psychiatry 2005; 62:165–172
  • Jick H, Kaye JA, Lick SS: Antidepressants and the risk of suicidal behaviors. JAMA 2004; 292:338–343
  • Khan A, Warner HA, Brown WA: Symptom reduction and sui-cide risk in patients treated with placebo in antidepressant clinical trials: An analysis of the Food and Drug Administration database. Arch Gen Psychiatry 2000; 57:311–317
  • Khan A, Khan SR, Leventhal RM, Brown WA: Symptom reduc-tion and suicide risk in patients treated with placebo in antidepres-sant clinical trials: A replication analyses of the Food and Drug Administration database. Int J Neuropsychopharmacol 2001; 4:113–118
  • Rotham KJ, Michels KB: The continuing unethical use of placebo controls. N Engl J Med 1995; 332:60–62
  • Greenberg RP, Bornstein RF, Zboroorowski MG, Fisher S, Greenberg MD: A meta-analysis of fluoxetine outcome in the treatment of depression. J Nerv Ment Dis 1994; 182:547–551
  • Emanuel EZ, Miller FG: The ethics of placebo-controlled trials—A middle ground. N Engl J Med 2001; 435:915–919
  • Lavori PW: Placebo control groups in randomized treatment trails: A statistician's perspective. Biol Psychiatry 2000; 47:717–723
  • Leber P: The use of placebo control groups in the assessment of psychiatric drugs: An historical context. Biol Psychiatry 2000; 47:699–706
  • Miller FG: Placebo-controlled trials in psychiatric research: An ethical perspective. Biol Psychiatry 2000; 47:707–716
  • U.S. Congress (1999) Freedom of Information Act. 5 Congress 552 (1994 and Supplement 11 1996) (http://www.usdij.gov/04foia/)
  • Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960; 23:55–62
  • Montgomery SA, Asberg M: A new depression scale designed to be sensitive to change. Br J Psychiatry 1979; 134:382–389
  • Khan A, Leventhal RM, Khan SR, Brown WA: Severity of depression and response to antidepressants and placebo: An
  • Khan A, Brodhead AE, Kolts RL, Brown WA: Severity of depressive symptoms and response to antidepressants and placebo in antidepressant trials. J Psychiatr Res 2005; 39:145–150
  • Frank JD, Frank JB: Persuasion and Healing: A comparative study of psychotherapy. Baltimore, MD: The Johns Hopkins University Press; 1991

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.