Press Release - Clinical Trial into Psilocybin Therapy for Psychological Distress in Palliative Care, PsyPal, Receives Medical Ethical Authorisation, with Conditions
University Medical Center Groningen
Zenodo (CERN European Organization for Nuclear Research) December 17, 2024 DOI: 10.5281/zenodo.18373801 (opens in new tab)
Study at a glance
AI-extracted from the abstract| Characteristics | Clinical trial Peer reviewed |
|---|---|
| Population | Patients with progressive, incurable diseases including COPD, multiple sclerosis, ALS, and atypical Parkinsonism and advanced Parkinson's disease |
| Intervention | psilocybin-assisted therapy |
| Topics | Psilocybin End-of-life distress |
| Keywords | Clinical trial Authorization Palliative care Ethical issues Medical ethics Psychotherapist Psychological distress Bioethics |
| Key findings | The PsyPal clinical trial has received medical ethical authorization under the EU Clinical Trials Regulation, with conditions, to proceed with evaluating psilocybin-assisted therapy for psychological distress in palliative care. |
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.
Comparable studies
Other non-randomized and open-label trials on psilocybin for end-of-life distress, most cited first.
| Study | Year | Design | Participants |
|---|---|---|---|
| PSilocybin for psYCHological and existential distress in PALliative care (PSYCHED-PAL): A single arm unblinded clinical trial Adults with advanced, incurable illness and estimated prognosis of 1–12 months,... | 2026 | Open label, single-arm clinical trial | n = 20 |
| Psilocybin-Assisted Early Palliative Care for Demoralization and Chronic Pain: An Open-Label Pilot Study. Cancer patients across the illness trajectory with demoralization and chronic pain | 2026 | Open-label pilot study | n = 11 |