Metten Somers, PhD, MBA
Psilocybin in patients with treatment resistant depression: first clinical experiences from a multicenter RCT.
Somers M2, Blom RE2, Koolen MHB2, Vischjager M1, Ywema P2, Parlevliet F1, van der Does FHS3, van der Wee NJA3, Schoevers RA1
1 Department of Psychiatry, University Medical Center Groningen, University of Groningen, Groningen, the Netherlands.
2 Department of Psychiatry, UMC Utrecht Brain Center, University Medical Center Utrecht, Utrecht, The Netherlands.
3 Department of Psychiatry, Leiden University Medical Center, Leiden, The Netherlands.
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).
To assess the efficacy, optimal dosage and safety of psilocybin in improving depressive symptoms in a large international multicenter randomized controlled trial, with by COMPASS Pathways as sponsor.
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.
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.
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.
1. Carhart-Harris RL, Bolstridge M, Rucker J, et al. Psilocybin with psychological support for treatment-resistant depression: an open-label feasibility study. The Lancet Psychiatry. 2016;3(7):619-627. doi:10.1016/S2215-0366(16)30065-7
2. Griffiths RR, Johnson MW, Carducci MA, et al. Psilocybin produces substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer: A randomized double-blind trial. J Psychopharmacol. 2016;30(12):1181-1197. doi:10.1177/0269881116675513
Metten Somers is a psychiatrist and Medical Head of the Affective and Psychotic Disorders Unit of the Department of Psychiatry at the UMC Utrecht. For his PhD thesis, he studied the relationship between language lateralization and left-handedness, using psychiatric genetic and neuroimaging techniques. Several analyses for this research project were performed at the Center for Neurobehavioral Genetics, UCLA, Los Angeles, California, USA, where he worked as a Visiting Researcher. Before taking his current position, Metten Somers worked as Project Manager for the OPTiMiSE trial, a first episode-psychosis EU FP7 study, that was centrally coordinated from the UMC Utrecht. From 2016-2018 he participated in the Executive MBA program at the Rotterdam School of Management, Erasmus University, Rotterdam, where he graduated with Dean’s Honours. His clinical work focuses on treatment resistant mood and psychotic disorders, with a special interest in electroconvulsive therapy. As a result from his work with treatment resistant depression in combination with an interest in the potential role for psychedelics in psychiatric disorders, Metten became involved as site-PI in the trial ‘Psilocybin in Treatment Resistant Depression’, the first international large scale multicenter randomized clinical trial investigating the effectiveness and safety of psilocybin in depressive illness, that in the Netherlands is executed in the UMC Utrecht, LUMC and UMCG.