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As early as in 1967, Leyburn noted in a Lancet article that “most antidepressant drugs cause side-effects which are recognizable by experienced doctors in a significant proportion of patients.

Nevertheless, some studies have shown that in trials with older drugs such as tricyclic antidepressants (TCAs), e.g., amitriptyline, the blind was frequently broken due to the drugs‘ marked side effects like sedation, drowsiness, dizziness and dry mouth. Īlthough the issue of unblinded outcome-assessors and patients has repeatedly been stressed for years as a major flaw in allegedly double-blind psychiatric drug trials, it is poorly studied because the vast majority of trials does not assess (or report) unblinding. Almost all antidepressant trials are at high or unclear risk of bias with respect to allocation concealment and blinding of outcome-assessors, two important biases known to inflate effect size estimates for subjective outcomes. One major issue with antidepressant trials is that they exclusively rely on subjective outcomes, that is, clinician-ratings of depression symptoms. The controversy about the clinical benefits of new-generation antidepressants for the acute treatment of depression is ongoing and unresolved. The Creative Commons Public Domain Dedication waiver ( ) applies to the data made available in this article, unless otherwise stated in a credit line to the data. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.