Abstract

The German EPIsoDE trial is a phase II, double-blind, active placebo controlled parallel group trial investigating the efficacy and safety of psilocybin administered in a psychotherapeutic setting in Treatment-Resistant major Depression (TRD) (Mertens et al., 2022). The trial has started in summer 2021 and is aiming to include 144 patients, recruited from the two trial sites, the Central Institute of Mental Health (CIMH) in Mannheim and the Charité Berlin. More than 80 % of the sample has already completed the trial. Although the final results of the study are not available yet, the study therapists and researchers intend to share some of their experiences and learnings from conducting therapy with psilocybin in patients with TRD.

This symposium will provide insights into the practical work within the EPIsoDE trial, while focussing on (i) risks and ethical challenges of this therapy in a study context, (ii) adverse events in psychedelic drug trials, and (iii) the importance of psychotherapy and integration in treatment with psilocybin.

Beyond the final efficacy data, those three topics are particularly relevant when discussing how to conduct psychedelic therapy in a safe and ethical manner.