Press Release - Clinical Trial into Psilocybin Therapy for Psychological Distress in Palliative Care, PsyPal, Receives Medical Ethical Authorisation, with Conditions

A clinical trial called PsyPal, which tests psilocybin-assisted therapy for psychological distress in palliative care, has received medical ethical authorization under EU regulations, with conditions, in participating member states. The multi-site study involves 19 partners across nine European countries and is coordinated by the University Medical Centre Groningen. It will evaluate the safety and efficacy of psilocybin therapy for patients with progressive, incurable diseases such as COPD, multiple sclerosis, ALS, and atypical Parkinsonism and advanced Parkinson's disease. The announcement clarifies the regulatory status and outlines next steps before patient recruitment begins.

Study at a glance

Abstract

This press release announces that the PsyPal clinical trial investigating psilocybin-assisted therapy for psychological distress in palliative care has received medical ethical authorisation under the EU Clinical Trials Regulation, with conditions, in the participating Member States. Coordinated by the University Medical Centre Groningen, PsyPal is a Horizon Europe-funded, multi-site clinical study involving 19 partners across nine European countries. The project aims to evaluate the safety and efficacy of psilocybin therapy for patients with progressive, incurable diseases, including COPD, multiple sclerosis, ALS, and atypical Parkinsonism and advanced Parkinson's disease. The release clarifies the regulatory status of the study, outlines next steps before patient recruitment, and reiterates the project’s commitment to the highest EU ethical standards.