The publication in April 2021 of the Imperial College London Phase II study investigating the efficacy of psilocybin-assisted therapy vs. escitalopram for depression reported differences in the primary outcome measure (the QIDS-SR16) between experimental and control arms as statistically insignificant (1). However, secondary measures of depression, and other relevant measures (see Appendix), favored psilocybin to escitalopram. Soon thereafter, a range of expert commentaries offered interpretations, including that the researchers were unfortunate in their choice of pre-registered primary outcome, the trial was underpowered perhaps revealing an overconfidence in designing the study, and the limitations of depression rating measures to capture the return of positive mood and well-being.
Partially in response to these publications, discussions in research and online communities have grown around the over-hyping of psychedelic treatments, bringing into focus concerns over psychedelic therapy trial methodology [for a peer-reviewed critique, see (2)]. This opinion piece explores these concerns to propose a response to this special issue’s question, “Can Psychedelic Therapies Open a New Frontier in Mental Healthcare (Or Will the Bubble Burst)?” Drawing on our experiences of working within psychedelic clinical trials and NHS psychiatry, we offer here a deflationary answer to this question, suggesting both will occur and outlining some of the facets, stakes and opportunities entailed.