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Placebo-related effects in clinical trials in schizophrenia: what is driving this phenomenon and what can be done to minimize it?

Larry Alphs, Fabrizio Benedetti, W. Wolfgang Fleischhacker, John M. Kane
DOI: http://dx.doi.org/10.1017/S1461145711001738 1003-1014 First published online: 1 August 2012

Abstract

The effect of placebo observed in schizophrenia clinical trials represents a growing problem that interferes with signal detection for treatments, increases costs of development, discourages investment in schizophrenia research and delays the introduction of new treatments. This paper seeks to clarify key issues related to this problem and identify potential solutions to them. Differences between placebo effect and response are characterized. Recent insights into the central nervous system mechanisms of placebo effect are described. This is followed by a description of protocol/study design and study conduct issues that are contributing to a growing placebo effect in clinical trials. Potential solutions to these problems are provided.

Key words
  • Clinical trials
  • placebo effect
  • placebo response
  • schizophrenia

The online version of this article is published within an Open Access environment subject to the conditions of the Creative Commons Attribution-NonCommercial-ShareAlike licence <http://creativecommons.org/licenses/by-nc-sa/2.5/>. The written permission of Oxford University Press must be obtained for commercial re-use.

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