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Nocebo effects in the treatment of major depression: results from an individual study participant-level meta-analysis of the placebo arm of duloxetine clinical trials

Dodd, Seetal, Schacht, Alexander, Kelin, Katarina, Dueñas, Hector, Reed, Victoria A., Williams, Lana J., Quirk, Frances H., Malhi, Gin S. and Berk, Michael 2015, Nocebo effects in the treatment of major depression: results from an individual study participant-level meta-analysis of the placebo arm of duloxetine clinical trials, Journal of clinical psychology, vol. 76, no. 6, pp. 702-711, doi: 10.4088/JCP.13r08858.

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Title Nocebo effects in the treatment of major depression: results from an individual study participant-level meta-analysis of the placebo arm of duloxetine clinical trials
Author(s) Dodd, SeetalORCID iD for Dodd, Seetal orcid.org/0000-0002-7918-4636
Schacht, Alexander
Kelin, Katarina
Dueñas, Hector
Reed, Victoria A.
Williams, Lana J.ORCID iD for Williams, Lana J. orcid.org/0000-0002-1377-1272
Quirk, Frances H.
Malhi, Gin S.
Berk, MichaelORCID iD for Berk, Michael orcid.org/0000-0002-5554-6946
Journal name Journal of clinical psychology
Volume number 76
Issue number 6
Start page 702
End page 711
Total pages 10
Publisher Wiley
Place of publication Weinheim, Germany
Publication date 2015
ISSN 1097-4679
1555-2101
Keyword(s) Social Sciences
Science & Technology
Life Sciences & Biomedicine
Psychology, Clinical
Psychiatry
Psychology
Antidepressants
Depression
RESPONSES
PERSONALITY
SYMPTOMS
BEHAVIOR
ANXIETY
PAIN
Summary BACKGROUND: The nocebo effect, when a harmless substance creates harmful effects in a person who takes it, is a clinically salient yet seldom studied phenomenon that may be associated with poorer treatment outcomes, perceived adverse events, and treatment discontinuation. The covert presence of nocebo responders in clinical trials may contribute to outcome variance in both placebo and active treatment arms for important primary and secondary endpoints. Nocebo effects are thought to be driven by expectancy and conditioning. METHOD: This study analyzed pooled clinical trial data in the placebo arms of controlled trials of antidepressant medications to investigate variables associated with the emergence of adverse outcomes in placebo-treated participants (N = 2,457). Specifically, we examined treatment-emergent adverse events (TEAEs) and discontinuation in placebo-treated individuals. Trials were commenced between 1993 and 2010 as studies of duloxetine versus active comparator and/or placebo. RESULTS: TEAEs were reported by 1,569 placebo-treated participants (63.9%), with 115 (4.7%) discontinuing from the studies due to TEAEs and 274 (11.2%) showing worsening of Hamilton Depression Rating Scale total score during placebo treatment. There was specifically no evidence to support the expectancy hypothesis, that reported TEAEs were influenced by adverse effects described in the clinical trials participant information and consent forms, or the conditioning hypothesis, that reported TEAEs would be influenced by adverse effect profiles of previous antidepressant medications used by these study participants. There was some evidence to suggest that people who had previously used complementary medications were more likely to report TEAEs. Variables specific to individual studies were the strongest predictors of TEAEs. DISCUSSION: In this study, TEAEs were very common among placebo-treated clinical trial participants. Unexpectedly, there was no evidence to associate TEAEs with adverse clinical outcomes, nor were the conditioning or expectancy hypotheses supported by these data. CONCLUSIONS: The nocebo effect is a common, covert, and poorly understood driver of clinical outcomes that requires further investigation.
Language eng
DOI 10.4088/JCP.13r08858
Field of Research 110999 Neurosciences not elsewhere classified
Socio Economic Objective 920410 Mental Health
HERDC Research category C1 Refereed article in a scholarly journal
Copyright notice ©2015, Wiley
Persistent URL http://hdl.handle.net/10536/DRO/DU:30074304

Document type: Journal Article
Collection: School of Medicine
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Created: Thu, 20 Aug 2015, 08:18:57 EST

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