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Disclosing the potential impact of placebo controls in antidepressant trials

  • Stephanie C. Chen (a1), Cheryl McCullumsmith (a2) and Scott Y. H. Kim (a3)
Abstract
Background

Although placebo-control clinical trials that withhold effective treatments can be permissible, how best to inform participants of the placebo design has received little attention.

Aims

To determine the effect of disclosing quantitative outcome estimates of individual treatment v. entering placebo-control randomised control trial (RCT) on willingness to enrol in such an RCT.

Method

We randomised 278 adult patients at a depression clinic to receive standard disclosure (n = 129) or enhanced (n = 149) quantitative outcome estimates (based on decision analysis) of individual treatment v. RCT, and assessed their willingness to enrol in the RCT.

Results

A greater proportion of those in the standard arm preferred enrolling in RCT (41.3% v. 23.8%, P = 0.002). Those in the standard arm preferred RCT more for direct benefit than altruism reasons, whereas the opposite was true in the enhanced arm.

Conclusions

Disclosing the quantitative outcome implications of placebos may select for fewer but more altruistic participants.

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Copyright
This is an Open Access article, distributed under the terms of the Creative Commons Attribution (CC-BY) license (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
Corresponding author
Scott Y. H. Kim, Department of Bioethics, 10 Center Drive, 1C118, Bethesda, MD 20892-1156, USA. Email: scott.kim@nih.gov
Footnotes
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Declaration of interest

S.Y.H.K. was a DSMB member of a clinical trial sponsored by Hoffman-LaRoche and he receives royalties from Oxford University Press for his book Evaluation of Capacity to Consent to Treatment and Research. C.M. has served in the past year on a scientific advisory board and as a consultant for Janssen Pharmaceuticals.

Footnotes
References
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Disclosing the potential impact of placebo controls in antidepressant trials

  • Stephanie C. Chen (a1), Cheryl McCullumsmith (a2) and Scott Y. H. Kim (a3)
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