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.
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.
Three preparation sessions, two supervised dosing sessions (15mg then 25mg) with integration sessions.
Escalating: 15 mg first session, 25 mg second session
Low-dose control receiving two 1 mg psilocybin sessions; optional open-label high-dose after primary endpoint.
Low-dose control (1 mg)