Abstract

Background:

Psilocybin is a classical psychedelic and occurs naturally in mushroom-species. In the 1950’s psilocybin was synthesized and introduced as augmentation strategy in psychotherapy for several psychiatric conditions. Recent years have seen a renewed interest in the therapeutic use of psilocybin. Two recent studies show a fast and often persistent reduction in depressive symptoms [1], [2].

Purpose:

To assess the efficacy, optimal dosage and safety of psilocybin in improving depressive symptoms in a large international multicentre randomized controlled trial, with by COMPASS Pathways as sponsor.

Methods:

In the RCT, 216 participants will be recruited in Europe, the USA and Canada before end of 2020. Participants are randomly assigned to double blind treatment with either 1mg, 10mg or 25mg of psilocybin. During the psilocybin-session, participants are guided by two trained therapists. Psilocybin-dosing is preceded by preparatory meetings with the therapist, integration sessions take place afterwards. The primary outcome is a reduction in depressive symptoms, measured with the MADRS.

Results:

The psilocybin-trial is currently running in the Netherlands in UMC Groningen, UMC Utrecht and LUMC Leiden. The first patients underwent psilocybin-treatment and new candidates are approved for inclusion.

Conclusion

Clinical experiences in treatment of the first RCT-participants will be discussed. The feasibility of treating this group of patients will be highlighted, as well as the subjective experience of patients undergoing this treatment. Finally, patients’ motivation for participation, experiences with patients after the psilocybin session and management of residual symptoms such as anxiety are discussed.