Effects of antidepressant discontinuation on response to psilocybin therapy in treatment resistant depression
Abstract
Psilocybin (4-phosphoryloxyl-N,N-dimethyltryptamine), a natural tryptamine occurring in psilocybe mushrooms, has shown promise in the treatment of major depressive disorder (MDD). In most clinical trials using psilocybin, any patients who are taking serotonergic antidepressants at screening are withdrawn from their medication before taking psilocybin, due in part due to concerns over safety and that antidepressants may attenuate psychedelic effects. A recent post-hoc analysis found reduced efficacy of psilocybin in patients with MDD who discontinued serotonergic antidepressants before trial entry compared to those who were unmedicated (Erritzoe et al., 2024). However, another small trial recently showed that psilocybin was safe and effective in patients with treatment resistant depression (TRD) who continued taking their SSRI (Goodwin et al., 2023). The Psilocybin in Depression Resistant to standard treatments (PsiDeR) trial was a two arm, double-blind, randomised, placebo-controlled phase 2 trial evaluating feasibility and safety of psilocybin versus placebo in adults with TRD. In this trial, participants who were taking an antidepressant at screening but were otherwise eligible were tapered and discontinued their medication prior to baseline. The aim of this analysis is to examine change in depressive symptoms from screening to baseline and during treatment with psilocybin, in those who discontinued an antidepressant prior to baseline compared to those who were unmedicated in the same time period. Further, we will examine whether there are differences between discontinued and unmedicated participants in acute psychedelic effects during psilocybin administration.
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