Psilocybin Therapy for Psychological Distress in Palliative Patients (PsyPal)
Quadruple-blind, randomised, low-dose controlled Phase II trial (n=108) comparing two escalating psilocybin doses (15 mg then 25 mg) versus two low doses (1 mg) in palliative patients with COPD, ALS, MS, or APD and co-morbid depression.
Details
PsyPal is a randomized, double-blind, low-dose controlled Phase II trial evaluating psilocybin therapy for depressive symptoms and psychological distress in patients with COPD, ALS, MS, or atypical Parkinsonian disorders with at least six months life expectancy.
Participants receive three preparation psychotherapy sessions, two supervised oral psilocybin dosing sessions (experimental: 15 mg then 25 mg; control: 1 mg twice), and five integration sessions; outcomes assessed at 6 weeks, 3 months and 6 months.
Primary endpoint is change in depression severity at 6 weeks after the second dose; secondary and exploratory measures include anxiety, demoralization, quality of life, biomarkers (EEG, blood), health-economic outcomes, and qualitative interviews.