"This paper presents updated and extended data from an open-label clinical trial assessing psilocybin with psychological support for treatment-resistant depression. Findings corroborate our (Carhart-Harris et al. 2016) and others’ previous results (Griffiths et al. 2016; Ross et al. 2016; Grob et al. 2011) supporting the safety and efficacy of psilocybin for depressive and anxiety symptoms. A fast and sustained response exceeding what might be expected from a placebo response was observed in many of the patients (see Carhart-Harris and Nutt (2016) for a relevant discussion). Notably, all 19 completers showed some reductions in the QIDS-SR16 scores at 1-week post-treatment and (nominally) maximal effects were seen at 5 weeks. Other interventions, not formally part of the present trial, confounded outcomes at 3 and 6 months, although safety was maintained and a sizeable proportion of the sample continued to demonstrate benefit (see Watts et al. (2017) for more details). Conclusions on efficacy are limited by the absence of a control condition in this trial, however.
"Recent studies (Griffiths et al. 2016; Ross et al. 2016; Carhart-Harris et al. 2016), including the present one, help demonstrate the feasibility of treating patients with major depressive disorder with psilocybin plus psychological support. Two recent double-blind randomised control trials (RCTs) of psilocybin for depression and anxiety symptoms in a combined sample of 80 patients with life-threatening cancer found consistent safety and efficacy outcomes with those reported here (Griffiths et al. 2016; Ross et al. 2016). Only a subset of patients recruited into these studies met the criteria for major depressive disorder however, and symptoms were not of the same severity as those seen here (i.e. mean baseline BDI scores were 18.1 and 16 in the Griffiths et al. and Ross et al. studies, respectively, whereas they were 35 in the present study). A comprehensive RCT designed to properly assess psilocybin’s efficacy for major depressive disorder, with some form of placebo control, is therefore warranted (Carhart-Harris and Goodwin 2017)."
Carhart-Harris RL, Bolstridge M, Day CMJ, et al. Psilocybin with psychological support for treatment-resistant depression: six-month follow-up. Psychopharmacology (Berl). 2018;235(2):399–408. doi:10.1007/s00213-017-4771-x