This is a joint announcement issued by the PsyPal consortium. PsyPal is the first fully EU-funded study to evaluate psilocybin therapy for depression and psychological distress in patients with palliative care needs, focusing on COPD, MS, ALS, and APD. Coordinated by the University Medical Centre Groningen and supported by 19 partners across nine countries, including Norrsken Mind, this €6.5 million Horizon Europe-funded project combines psychotherapy and psilocybin treatment to address critical gaps in end-of-life care.

The PsyPal consortium ("Consortium") is proud to announce that the clinical trial PsyPal has been authorised according to the Clinical Trials Regulation (CTR) in the participating member states, with conditions. The Consortium is working towards finalising the process to ensure compliance with CTR and collaborating with the funding agency in the context of a planned independent Ethics Review procedure, which is still ongoing. Completion of the process is a prerequisite to commence the trial. By working closely with regulators and ethics committees, the Consortium is dedicated to ensuring compliance and upholding the highest EU ethical standards.

This milestone marks a significant step for the first fully EU-funded study of psilocybin therapy in palliative care, set to begin recruiting patients in 2025. 

Coordinated by the University Medical Centre Groningen (UMCG) in the Netherlands, the PsyPal project is supported by Horizon Europe with €6.5M in funding. PsyPal aims to evaluate the safety and efficacy of psilocybin therapy in alleviating psychological distress for patients with progressive, incurable diseases. This multi-site clinical trial will focus on four specific conditions: chronic obstructive pulmonary disease (COPD), multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS), and atypical Parkinson’s disease (APD).

This authorisation reflects a year of collaborative effort across the PsyPal consortium, which includes contributions from 35 co-authors from 19 partners from nine European countries. The consortium is supported by an industry partner, Avextra, which is providing the study drug psilocybin for the clinical study and are supporting the regulatory process.

“This achievement is a testament to the dedication and expertise of our team,” said Robert Schoevers, Principal Investigator of PsyPal and Head of Psychiatry at UMCG. “We are eager to start enrolling patients for the clinical trial, which has the potential to transform care for patients facing severe psychological and existential distress once all approvals are in place.”

Error in previous communication: The study has authorisation according to the Clinical Trials Regulation and not EMA approval

• A previous miscommunication occurred in a press release issued by the Consortium's pharmaceutical partner. The press release inaccurately suggested that the study drug had received EMA approval, which is incorrect. The authorisation obtained pertains to the Clinical Trials Regulation, which harmonises the assessment and supervision processes for clinical trials across the EU.

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‍Disclaimer: PsyPal is funded by the European Union. Views and opinions expressed are those of the authors and do not necessarily reflect those of the European Union or the Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them.

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