titre de la présentation : First results from the EPIsoDE trial, a phase IIb study to assess efficacy and safety of psilocybin for treatment-resistant depression
un court abstract:
Psilocybin is being extensively studied for treating depressive disorders, with promising results. The German EPIsoDE trial
(EudraCT: 2019-003984-24; NCT04670081) is a randomized, double-blind, placebo-controlled study comparing high-dose (25 mg)
and low-dose (5 mg) psilocybin with an active placebo (100 mg nicotinamide) in patients with treatment-resistant depression (TRD).
Between July 2021 and February 2024, 144 patients were treated at two sites (Charité Berlin and CIMH Mannheim).
Participants were assigned to one of four treatment arms, receiving one or two doses of psilocybin, with all patients receiving
at least one high dose for ethical reasons. This talk will present the study’s rationale and early results, along with insights
from treating this vulnerable TRD population. Challenges and lessons from the trial will be discussed, with implications for future
research and clinical practice.
