In a recent phase II clinical trial evaluating psilocybin in the management of treatment resistant major depression, what were the severe adverse events reported?
Goodwin GM et al. performed a double-blind trial to compare the change from baseline to week 3 of the total score on the Montgomery Asberg Depression Rating Scale after a single dose of a synthetic formulation of psilocybin at doses of 25 mg, 10 mg or 1 mg. The 25 mg single dose resulted in reduced depression scores compared to the 10 mg single dose over a period of 3 weeks. However, the single dose of 25 mg resulted in more adverse events. 3% of the subjects in the 25 mg group had serious adverse events including: suicidal behavior; anxiety and depression.
Goodwin GM et al. Single-Dose Psilocybin for a Treatment-Resistant Episode of Major Depression. NEJM 2022; 387(18): 1637-1648.