Psilocybin Therapy for Psychological Distress in Palliative Patients (PsyPal)

This quadruple-blind, randomised, low-dose controlled trial (n=108) will study the safety and effectiveness of psilocybin therapy in reducing depression and psychological distress in palliative patients with chronic obstructive pulmonary disease (COPD), amyotrophic lateral sclerosis (ALS), multiple sclerosis (MS), or atypical Parkinsonian disorder (APD). Participants will receive either two escalating doses of psilocybin (15mg followed by 25mg) or two low doses (1mg).

The study, conducted by the University Medical Center Groningen, aims to determine whether psilocybin therapy can provide rapid and sustained relief from depressive symptoms, anxiety, demoralisation, and end-of-life distress over a six-month period. Participants will undergo three preparatory therapy sessions, two supervised psilocybin dosing sessions (6-8 hours each), and five integration therapy sessions. Follow-up assessments will take place at 6 weeks, 3 months, and 6 months post-treatment. A digital care platform and peer support groups will be available throughout the study period.

The primary outcome is the change in depression severity from baseline to 6 weeks after the second psilocybin session. Secondary measures include anxiety, quality of life, spirituality, attachment, and coping with illness. Exploratory analyses will assess biomarkers (EEG and blood-based), cost-effectiveness, and long-term psychological effects. Control group participants will have the option to receive a single 25 mg psilocybin dose after the initial study period. The trial is expected to start in March 2025 and complete in January 2028.

Topic Palliative Care Depression Safety
Compound Psilocybin
Country Netherlands
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University of Groningen
The University of Groningen, established in 1614, is a prestigious institution that ranks among the world's top universities. It has taken a pioneering role in the interdisciplinary research of psychedelics, harnessing its rich academic heritage and a forward-looking approach to exploring the potential of psychedelic substances in treating various mental health conditions.

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