Psilocybin for Treatment-Resistant Major Depression - Results and Learnings from the EPIsoDE Trial

Abstract

Psilocybin is intensively researched in the treatment of depressive disorders with promising results. This presentation will be about the final results of a large investigator initiated trial, the German EPIsoDE trial. 

The EPIsoDE trial (EudraCT: 2019-003984-24) is a phase 2b, bicentric, randomized, double-blind, active placebo-controlled parallel-group study investigating the effects of a high-dose psilocybin (25 mg) and a low-dose psilocybin (5 mg) versus an active placebo (100 mg nicotinamide) administered orally in a psychotherapeutic context in 144 patients with Treatment-Resistant major Depression (TRD). Due to its innovative design, all patients received at least one supposedly therapeutic psilocybin dose (25 mg), thereby accounting for unblinding and potential nocebo effects – some of the most important methodological drawbacks in psychedelic trials. 

Besides the study rationale and final results, important implications for psychedelic clinical trials will be discussed, particularly when conducted in vulnerable patient populations that are often characterized by chronicity of disease, adverse childhood experiences, interpersonal traumatization and limited resources. 

Biography

Lea Mertens is a clinical psychologist and researcher. She received her M.Sc. in Cognitive and Clinical Neuroscience with a specialization in Neuropsychology from Maastricht University. During her Master’s she worked at the Centre for Psychedelic Research, Imperial College London. For her PhD she has joined the Department of Molecular Neuroimaging, headed by Prof. Gerhard Gründer, at the Central Institute of Mental Health focusing on clinical trial with psychedelics. She is currently study coordinator, therapist and researcher in  a German clinical trial investigating the “Efficacy and Safety of Psilocybin in Treatment-Resistant Depression” (EPIsoDE).