Journal article
Predictors of the placebo response in a nutraceutical randomized controlled trial for depression
R Arnold, J Murphy-Smith, CH Ng, D Mischoulon, GJ Byrne, CA Bousman, C Stough, M Berk, J Sarris
Journal of Integrative Medicine | ELSEVIER | Published : 2024
Abstract
Objective: The placebo response in depression studies is the change in symptoms amongst those who receive an inactive treatment. Many well-designed randomized controlled trials (RCTs) of depression have a high proportion of placebo responders, with little understanding as to why. The present study assesses characteristics associated with the placebo response in a nutraceutical trial with a large proportion of placebo responders. Methods: This is a secondary analysis of a nutraceutical depression RCT which identified no overall treatment benefit relative to placebo (n = 69 in placebo group). We investigated participant characteristics such as socio-demographics, clinical features, and recruit..
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Grants
Awarded by National Health and Medical Research Council
Funding Acknowledgements
The parent trial of this secondary analysis was funded by an Australian National Health and Medical Research Council projectgrant (No. APP1048222) and was co-sponsored by FIT-BioCeuticals (who provided the trial product and placebo) . JeromeSarris is supported by an NHMRC Fellowship (No. APP1125000) .Michael Berk is supported by a NHMRC Senior Principal Research Fellowship (No. 1059660 and 1156072) . BioCeuticals was not involved in any aspect of study design, analysis, manuscript preparation or the decision to submit this manuscript for publication.