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Determining maximal achievable effect sizes of antidepressant therapies in placebo-controlled trials
SMHI, Research Department, Oceanography.
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2021 (English)In: Acta Psychiatrica Scandinavica, ISSN 0001-690X, E-ISSN 1600-0447Article in journal (Refereed) Published
Abstract [en]

Objective Antidepressants outperform placebo with an effect size of around 0.30. It has been suggested that effect sizes as high as 0.875 are necessary for a minimal clinically important difference. Whether such effect sizes are achievable in placebo-controlled trials is unknown. Therefore, we aimed to assess what effect sizes are theoretically achievable in placebo-controlled trials of antidepressants. Methods Patient-level analyses comparing Hamilton Depression Rating Scale (HDRS-17) outcomes for simulated antidepressant therapies to placebo-treated participants (n = 2201) from clinical trials of selective serotonin reuptake inhibitors. Results An optimally effective antidepressant, where all treated participants achieve HDRS-17 scores comparable to those displayed by healthy volunteers (remission-type model), had a maximum effect size of 1.75, with a mean difference of 11.6 points on the HDRS-17. In simulations where patients received an additional 50% symptom reduction over that obtained with placebo (improvement-type model), the maximum effect size was 1.08 with a mean HDRS-17 difference of 7.2. When adjusting for normal rates of treatment discontinuation, maximum effect sizes were 1.10 (remission-type model) and 0.76 (improvement-type model) with HDRS-17 mean differences of 8.8 and 5.6, respectively. Conclusions Three methodological issues (i) a large and variable placebo response, (ii) a high rate of dropout and (iii) HDRS-17-ratings significantly larger than zero in healthy volunteers, reduce the degree of treatment-placebo separation achievable in depression trials. Assuming that those who discontinue treatment have only partial response, even a highly effective antidepressant would have difficulties surpassing such effect size cut-offs as have been suggested to signify a minimal clinically important difference.

Place, publisher, year, edition, pages
2021.
National Category
Oceanography, Hydrology and Water Resources Basic Medicine
Research subject
Environment; Oceanography
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URN: urn:nbn:se:smhi:diva-6137DOI: 10.1111/acps.13340ISI: 000670514400001PubMedID: 34146343OAI: oai:DiVA.org:smhi-6137DiVA, id: diva2:1582700
Available from: 2021-08-03 Created: 2021-08-03 Last updated: 2021-08-03Bibliographically approved

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Hieronymus, Magnus

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