Open-label, single-arm pilot study (n=12) of two supervised oral psilocybin sessions (10 mg then 25 mg, ~2 weeks apart) for depression and anxiety in people with Parkinson's disease; primary outcomes safety, tolerability, and feasibility.
This open-label single-group pilot study tests the safety, tolerability, and feasibility of psilocybin therapy in people with early-stage Parkinson's disease who have depressive or anxious disorders.
Participants receive preparation sessions, then a first supervised 10 mg oral psilocybin session; those without significant adverse events may receive a second supervised 25 mg session about two weeks later. Psychological support and medical monitoring are provided during dosing.
Follow-up visits continue to three months after the second dosing to assess safety, Parkinson's and psychiatric symptoms, and feasibility of procedures; primary endpoints focus on adverse events and tolerability.
Open-label single-group psilocybin therapy with preparation and integration sessions; one or two oral dosing sessions approximately two weeks apart.
First session: 10 mg oral psilocybin with psychological support and monitoring.
Second session (conditional, ~2 weeks later): 25 mg oral psilocybin with psychological support and monitoring.