Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Citation Map Email this article to a Colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Add to My Articles & Searches Download to citation manager Citing Articles via HighWire Citing Articles via Google Scholar Articles by Storosum, J. G. Articles by Broekmans, A. W. Search for Related Content PubMed Citation Articles by Storosum, J. G. Articles by Broekmans, A. W. Miscellaneous Ethics Depression Suicide Antidepressants Epidemiology

Suicide Risk in Placebo-Controlled Studies of Major Depression

OBJECTIVE: The purpose of this study was to determine if fear of an increased risk of attempted suicide in placebo groups participating in placebo-controlled studies is an argument against the performance of placebo-controlled trials in studies of major depression. METHOD: All short-term and long-term, placebo-controlled, double-blind studies that were part of a registration dossier for the indication of major depression that were submitted to the Medicines Evaluation Board, the regulatory authority of the Netherlands, from 1983 to 1997 were reviewed for attempted suicide. In addition, all long-term, placebo-controlled studies from a MEDLINE search that were conducted in the last decade in patients with major depression were assessed for attempted suicide. RESULTS: In 77 short-term studies with 12,246 patients in dossiers from the Medicines Evaluation Board, the incidence of suicide was 0.1% in both placebo groups and active compound groups. The incidence of attempted suicide was 0.4% in both placebo groups and active compound groups. In eight long-term studies with 1,949 patients, the incidence of suicide in the placebo groups was 0.0% and 0.2% in the active compound groups. Attempted suicide occurred in 0.7% of both placebo groups and active compound groups. In seven long-term MEDLINE studies, the incidence of attempted suicide in the placebo groups was not higher than in the groups treated with active compound. CONCLUSIONS: Fear of increased risk of attempted suicide in the placebo groups should not be an argument against performing short-term and long-term, placebo-controlled trials in major depression.

This article has been cited by other articles:

				M. Stone, T. Laughren, M L. Jones, M. Levenson, P C. Holland, A. Hughes, T. A Hammad, R. Temple, and G. Rochester Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration BMJ, August 11, 2009; 339(aug11_2): b2880 - b2880. [Abstract] [Full Text] [PDF]

				G. Kotzalidis, I. Pacchiarotti, G. Manfredi, V. Savoja, C. Torrent, L. Mazzarini, C. Tatarelli, B. Amann, S. Di Marzo, J. Sanchez-Moreno, et al. Ethical questions in human clinical psychopharmacology: should the focus be on placebo administration? J Psychopharmacol, August 1, 2008; 22(6): 590 - 597. [Abstract] [PDF]

				R. H. Perlis, S. Purcell, M. Fava, J. Fagerness, A. J. Rush, M. H. Trivedi, and J. W. Smoller Association Between Treatment-Emergent Suicidal Ideation With Citalopram and Polymorphisms Near Cyclic Adenosine Monophosphate Response Element Binding Protein in the STAR*D Study Arch Gen Psychiatry, June 1, 2007; 64(6): 689 - 697. [Abstract] [Full Text] [PDF]

				A. Rubino, N. Roskell, P. Tennis, D. Mines, S. Weich, and E. Andrews Risk of suicide during treatment with venlafaxine, citalopram, fluoxetine, and dothiepin: retrospective cohort study BMJ, February 3, 2007; 334(7587): 242 - 242. [Abstract] [Full Text] [PDF]

				D. Healy Did regulators fail over selective serotonin reuptake inhibitors? BMJ, July 8, 2006; 333(7558): 92 - 95. [Full Text] [PDF]

				T. A. Hammad, T. Laughren, and J. Racoosin Suicidality in pediatric patients treated with antidepressant drugs. Arch Gen Psychiatry, March 1, 2006; 63(3): 332 - 339. [Abstract] [Full Text] [PDF]

				G. E. Simon, J. Savarino, B. Operskalski, and P. S. Wang Suicide Risk During Antidepressant Treatment Am J Psychiatry, January 1, 2006; 163(1): 41 - 47. [Abstract] [Full Text] [PDF]

				J. G. Storosum, T. Wohlfarth, C. C. Gispen-de Wied, D. H. Linszen, B. P.R. Gersons, B. J. van Zwieten, and W. van den Brink Suicide Risk in Placebo-Controlled Trials of Treatment for Acute Manic Episode and Prevention of Manic-Depressive Episode Am J Psychiatry, April 1, 2005; 162(4): 799 - 802. [Abstract] [Full Text] [PDF]

				D. Chisholm, K. Sanderson, J. L. Ayuso-Mateos, and S. Saxena Reducing the global burden of depression: Population-level analysis of intervention cost-effectiveness in 14 world regions The British Journal of Psychiatry, May 1, 2004; 184(5): 393 - 403. [Abstract] [Full Text] [PDF]

				D. J. Nutt Death and Dependence: Current Controversies over the Selective Serotonin Reuptake Inhibitors J Psychopharmacol, December 1, 2003; 17(4): 355 - 364. [Abstract] [PDF]

				P. H Ankarberg Antidepressant prescribing and suicide: Antidepressants do not reduce suicide rates BMJ, July 31, 2003; 327(7409): 288 - 289. [Full Text]

				S. Y.H. Kim and R. G. Holloway Burdens and Benefits of Placebos in Antidepressant Clinical Trials: A Decision and Cost-Effectiveness Analysis Am J Psychiatry, July 1, 2003; 160(7): 1272 - 1276. [Abstract] [Full Text] [PDF]

				J. G. Storosum, B. J. van Zwieten, T. Wohlfarth, L. de Haan, A. Khan, and W. van den Brink Suicide Risk in Placebo vs Active Treatment in Placebo-Controlled Trials for Schizophrenia Arch Gen Psychiatry, April 1, 2003; 60(4): 365 - 368. [Abstract] [Full Text] [PDF]

Get information about faster international access.

Privacy Policy

Copyright © 2001 American Psychiatric Association. All rights reserved.

Home | Search | Current Issue | Past Issues | Subscribe | All APPI Journals | Help | Contact Us