This randomised controlled trial (n=60) will assess the efficacy of oral psilocybin therapy for depression in individuals with Parkinson’s disease.
Randomised, parallel-design trial enrolling 60 people with Parkinson's disease and clinically significant depressive symptoms to evaluate psilocybin therapy.
Participants receive three preparation sessions, two supervised oral psilocybin administration sessions (one dose per session; 6–8 hours each), five integration sessions, and follow-up visits to 3 months after the second session.
Outcomes include measures of depression, motor and non-motor PD symptoms, quality of life, neuroimaging and blood-based biomarkers, and safety/tolerability.
Oral psilocybin administered in two supervised sessions with preparatory and integration therapy.
Dose range from low (microdose) to high per protocol; randomized dose assignment; one dose per administration session; medically supervised (6–8 h).