Periodic Reporting for period 1 - PsyPal (Psilocybin Therapy for Psychological Distress in Palliative Care Patients)
Berichtszeitraum: 2024-01-01 bis 2025-06-30
The PsyPal project addresses the profound psychological and existential distress experienced by patients in palliative care with illnesses like COPD, ALS, MS, and Atypical Parkinsonian Disorders, for whom current treatments are often inadequate. We are investigating psilocybin therapy as a novel approach to alleviate this suffering. The project's central objective is a rigorous, multi-centre clinical trial across four EU countries to evaluate the safety and effectiveness of a standardized, patient-centered psilocybin therapy.
In its first 18 months, PsyPal established the complete foundation for this trial, securing full regulatory and ethical approval in the Netherlands, Denmark, Portugal, and the Czech Republic. A comprehensive therapy manual was developed, therapists were trained to a consistent standard, and key infrastructure—including study drug delivery, a digital care platform, and peer-support networks—is in place. Beyond evaluating clinical value, the project seeks to understand the therapy's mechanisms by analyzing biological and psychological data to identify predictive markers for patient response. Ultimately, PsyPal aims to pave the way for the ethical, cost-effective, and sustainable integration of psilocybin therapy into European palliative care, improving quality of life for patients and their families.
Beyond the clinical trial, PsyPal is dedicated to creating a sustainable framework for the future. This includes developing a model for continued care with peer-support networks and a digital platform to support patients and their families after the treatment period. By engaging with patients, policymakers, and healthcare stakeholders from the outset, the project aims to pave the way for the ethical and cost-effective integration of this novel therapy into European healthcare systems, ultimately offering a new path to alleviate suffering and improve the quality of life for those in palliative care.
In its first 18 months, PsyPal established the complete foundation for this trial, securing full regulatory and ethical approval in the Netherlands, Denmark, Portugal, and the Czech Republic. A comprehensive therapy manual was developed, therapists were trained to a consistent standard, and key infrastructure—including study drug delivery, a digital care platform, and peer-support networks—is in place. Beyond evaluating clinical value, the project seeks to understand the therapy's mechanisms by analyzing biological and psychological data to identify predictive markers for patient response. Ultimately, PsyPal aims to pave the way for the ethical, cost-effective, and sustainable integration of psilocybin therapy into European palliative care, improving quality of life for patients and their families.
Beyond the clinical trial, PsyPal is dedicated to creating a sustainable framework for the future. This includes developing a model for continued care with peer-support networks and a digital platform to support patients and their families after the treatment period. By engaging with patients, policymakers, and healthcare stakeholders from the outset, the project aims to pave the way for the ethical and cost-effective integration of this novel therapy into European healthcare systems, ultimately offering a new path to alleviate suffering and improve the quality of life for those in palliative care.
Over the first 18 months, the project established a robust operational and scientific framework. Key achievements include the finalization and approval of the multi-site clinical trial protocol across all four participating countries. The GMP-certified study drug (psilocybin) and placebo were manufactured and delivered to all clinical sites.
A detailed therapy manual was created to standardize the therapeutic approach, and a comprehensive training program was delivered to all study therapists, ensuring high fidelity to the treatment protocol. Preparatory work for investigating the therapy's mechanisms of change was completed, with harmonized protocols for collecting neurobiological and psychological data now in place. A framework for continued care was also established, featuring a digital care platform and peer-support networks to provide ongoing resources for patients and families. Despite a delay in the multi-national approval process, patient screening has now begun, with strong interest from potential participants.
A key achievement is a Design Thinking Workshop hosted by PsyPal partner IESE, which was instrumental in engaging professionals, regulators, and companies to lay the groundwork for a sustainable ecosystem for psychedelic therapy delivery. These established connections are crucial for facilitating the adoption of project results and adapting future palliative care policies.
A detailed therapy manual was created to standardize the therapeutic approach, and a comprehensive training program was delivered to all study therapists, ensuring high fidelity to the treatment protocol. Preparatory work for investigating the therapy's mechanisms of change was completed, with harmonized protocols for collecting neurobiological and psychological data now in place. A framework for continued care was also established, featuring a digital care platform and peer-support networks to provide ongoing resources for patients and families. Despite a delay in the multi-national approval process, patient screening has now begun, with strong interest from potential participants.
A key achievement is a Design Thinking Workshop hosted by PsyPal partner IESE, which was instrumental in engaging professionals, regulators, and companies to lay the groundwork for a sustainable ecosystem for psychedelic therapy delivery. These established connections are crucial for facilitating the adoption of project results and adapting future palliative care policies.
PsyPal's results advance palliative care and psychedelic science. We have developed the first standardized, multi-national framework for psilocybin therapy in non-cancer palliative conditions (COPD, ALS, MS, APD), creating a replicable model for diverse European healthcare systems.
This innovation extends beyond the clinical intervention to an integrated ecosystem for patient support, including a comprehensive therapy manual, standardized therapist training, a digital aftercare platform, and peer-support networks. The project also deepens scientific understanding by integrating a framework to study the neurobiological and psychological mechanisms of the therapy, aiming to identify who benefits most and why. This moves the field towards more personalized treatment. Finally, PsyPal is proactively building a foundation for societal and healthcare integration by analyzing care pathways and forming a coalition of stakeholders (patients, clinicians, researchers, policymakers) to create a supportive regulatory and standardization framework for the ethical deployment of these therapies.
This innovation extends beyond the clinical intervention to an integrated ecosystem for patient support, including a comprehensive therapy manual, standardized therapist training, a digital aftercare platform, and peer-support networks. The project also deepens scientific understanding by integrating a framework to study the neurobiological and psychological mechanisms of the therapy, aiming to identify who benefits most and why. This moves the field towards more personalized treatment. Finally, PsyPal is proactively building a foundation for societal and healthcare integration by analyzing care pathways and forming a coalition of stakeholders (patients, clinicians, researchers, policymakers) to create a supportive regulatory and standardization framework for the ethical deployment of these therapies.