European Neuropsychopharmacology
Volume 20, Issue 8 , Pages 562-567, August 2010

Relationship between probability of receiving placebo and probability of prematurely discontinuing treatment in double-blind, randomized clinical trials for MDD: A meta-analysis

  • Enrico Tedeschini

      Affiliations

    • Depression Clinical and Research Program at Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
    • Department of Psychiatry, University of Modena and Reggio Emilia, Modena, Italy
    • Corresponding Author InformationCorresponding author. Depression Clinical and Research Program, Massachusetts General Hospital, 50 Staniford Street, Boston, Massachusetts 02114, USA. Tel.: +1 617 513 6821; fax: +1 617 726 7541.
  • ,
  • Maurizio Fava

      Affiliations

    • Depression Clinical and Research Program at Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  • ,
  • Tracie M. Goodness

      Affiliations

    • Depression Clinical and Research Program at Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA
  • ,
  • George I. Papakostas

      Affiliations

    • Depression Clinical and Research Program at Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts, USA

Received 10 November 2009; received in revised form 14 January 2010; accepted 3 February 2010. published online 10 March 2010.

Abstract 

An increased likelihood of receiving placebo in randomized clinical trials has been found to predict greater chances of trial success. However, patients who are less likely to receive active therapy (and more likely to receive placebo) may be at increased risk of attrition which, in turn, can limit the statistical power of a study. Therefore, in the present work, we sought to investigate the relationship between the probability of receiving placebo and the likelihood of prematurely discontinuing treatment. Medline/Pubmed publication databases were searched for RCT in MDD. A meta-regression established that the likelihood of receiving placebo did not predict either antidepressant discontinuation rates, placebo-discontinuation rates or the risk ratio of discontinuing antidepressants versus placebo. An increased likelihood of receiving placebo did not inflate discontinuation rates which did not influence the degree of antidepressant-placebo “separation”.

Keywords: Antidepressant, Placebo, Discontinuation, Major, Depressive, Disorder, Adults

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PII: S0924-977X(10)00023-4

doi:10.1016/j.euroneuro.2010.02.004

European Neuropsychopharmacology
Volume 20, Issue 8 , Pages 562-567, August 2010