European Union funds groundbreaking research into psychedelic therapy

A European consortium of 19 partners has been awarded over €6.5M by the European Union to study psilocybin to treat psychological distress in people with progressive incurable illnesses requiring palliative care. This is the first time the EU has funded a multi-site clinical study into psychedelic-assisted therapy.

The randomised controlled trial (RCT) PsyPal, coordinated by the University Medical Centre
Groningen in the Netherlands, and in collaboration with HumanKindLabs, marks the firstever European grant to fund clinical research into psychedelic-assisted therapy. The trial
will investigate whether psilocybin therapy can help ease psychological and existential
distress in patients suffering from one of four different progressive diseases: the lung
condition chronic obstructive pulmonary disorder (COPD), multiple sclerosis (MS),
amyotrophic lateral sclerosis (ALS, also known as MND), and atypical Parkinson’s disease
(APD).
Commencing in early 2024, the PsyPal study will launch with the aim of treating over one hundred
patients across four distinct clinical sites where each focsues on a specific condition: COPD at
the University Medical Centre Groningen (UMCG) in the Netherlands, APD at the Champalimaud
Foundation in Portugal, MS at the National Institute of Mental Health in the Czech Republic, and
ALS, jointly at the University of Copenhagen and the Bispebjerg Hospital in Denmark.
Participants will undergo two therapy sessions, receiving psilocybin (the active ingredient in
psychedelic or ‘magic’ mushrooms) or a placebo. Previous pilot studies have shown substantial
reduction in depressed mood and anxiety in people living with a terminal cancer diagnosis, with
sometimes persistent benefits.
PsyPal marks the first clinical trial studying the safety and effects of psilocybin in non-oncology
palliative care patients. Robert Schoevers, head of psychiatry at the UMCG and principal
investigator of PsyPal notes: “We are eager to see if we can ease the suffering of these patients
whilst also examining longer-term patient and family outcomes of this treatment, something that
often gets overlooked but that is of enormous importance.”
European funding
This first-of-its-kind clinical trial is fully funded by Horizon Europe, the European Union’s key
funding programme for research and innovation. Horizon Europe aims to foster collaboration,
bolster the impact of research and innovation, and address global challenges through the
facilitation of EU policies.
Schoevers says, “We are absolutely thrilled that the EU is supporting this ambitious collaborative
study. There is growing recognition that psychedelic treatments may help patients for whom
alternatives are not effective, and I am very glad we are receiving support from this highly
prestigious funding program. It really helps to strengthen the collaboration between researchers
from different countries and disciplines, focusing on potentially transformative interventions for
severe, currently treatment-resistant mental disorders.”
Psychological and existential distress
All four diseases are incurable and profoundly life-altering, leading to a loss of autonomy and
severe psychological distress. Studies indicate that depression and anxiety symptoms affect 34%
to 80% of individuals across these conditions, emphasising the pressing need for innovative
interventions.
The impact of life-limiting or life-threatening illnesses on one’s physical, emotional, social, and
spiritual well-being is profound. While some experience personal growth, others are confronted
with a multitude of existential struggles, such as loss of hope and meaning, changes in family and
societal roles, and feelings of burden. Consequently, depression, anxiety, demoralisation, and
decreased quality of life are highly prevalent among these patients. Conventional interventions
often fall short for these palliative care patients. This necessitates the need for innovative and
effective treatments, such as psilocybin therapy.
Innovative therapeutic approach
Recent research in psychedelic science, particularly centred on psilocybin, has demonstrated
promising therapeutic outcomes for individuals grappling with depression and spiritual distress
due to incurable illnesses, such as cancer. Psychedelic-assisted psychotherapy, which integrates
the use of psilocybin in a secure setting alongside professional psychological support, is
introducing an innovative therapeutic approach that addresses not just symptoms of depression
and anxiety but also promotes spiritual well-being and quality of life in palliative care patients.
PsyPal combines psychotherapy and pharmacotherapy to address these deep-seated human
needs in these terminal conditions. Beyond immediate clinical outcomes, it targets sustained wellbeing for patients and their families post-psilocybin treatment. Using peer support and online
tools, the project aims to enhance coping mechanisms and alleviate distress as people approach
the end of their lives.
Collaborative and interdisciplinary consortium
This pioneering approach results in not just a clinical trial, but an interdisciplinary partnership
consisting of 19 collaborating European organisations from 9 different countries. The consortium
brings together a wide variety of specialists, including psychiatrists, palliative care physicians,
psychologists, and experts in psilocybin therapy, alongside researchers focusing on spiritual care
and representatives from religious institutions.
PsyPal Partners
The following organisations are part of the PsyPal consortium (listed alphabetically): 29k, A+
Science, Bispebjerg Hospital, Champalimaud Foundation, European Association for Palliative
Care (EAPC), European Federation of Neurological Associations (EFNA), European Psychiatric
Association (EPA), HumanKindLabs, IESE Business School, Lung Alliance Netherlands, Madopa,
National Institute of Mental Health in the Czech Republic, Norrsken Mind, OPEN Foundation,
University Medical Center Groningen (UMCG), University of Copenhagen, University of Groningen,
University of Stockholm, Uppsala University.
In addition, the PsyPal consortium will be also actively engaging with PAREA (the Psychedelic
Access and Research Europe Alliance).