Placebo controls in clinical trials : concerns about use in relapse prevention studies in schizophrenia

Emsley, Robin A. ; Turoff, Sarah ; Fleischhacker, W. Wolfgang ; Galderisi, Silvana ; Halpern, Lisa J. ; McEvoy, Joseph P. ; Schooler, Nina R. (2016)

CITATION: Emsley, R., et al. 2016. Placebo controls in clinical trials : concerns about use in relapse prevention studies in schizophrenia. BMJ, 354:i4728, doi:10.1136/bmj.i4728.

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ENGLISH SUMMARY : The use of placebos in clinical trials has major policy implications for ethical conduct across all of medicine and is relevant to clinicians, patients, drug development, and regulatory agencies. This article focuses on the use of placebos in relapse prevention studies in schizophrenia. However, the issues discussed are similar to those encountered in many other clinical trial situations. These include underestimating the risk of harm associated with trial participation, the risk of coercion, insufficient awareness of the risks by participants, and the risk of loss of trust between the patient and doctor. While the debate around using placebos in clinical trials of schizophrenia is long running, several developments make it imperative to readdress the topic. Firstly, new research has reported deleterious effects of relapse,1 challenging the previous assumption that relapse is not associated with a risk of lasting harm. Secondly, new questions have been raised about the need for maintenance treatment in schizophrenia.2 Thirdly, ethical standards have evolved, with reduced tolerance of exposure of participants to risk and greater respect of patient autonomy. Finally, and most importantly, recent publications from both the European Medicines Agency and US Food and Drug Administration continue to encourage the use of placebos in schizophrenia trials.

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