This is an open-label single-arm pilot study of oral psilocybin therapy for depression and anxiety in people with Parkinson's Disease (PD). The primary goal is to examine safety, tolerability, and feasibility of the intervention in this patient population. We will enroll ten people ages 40 to 75 with clinically diagnosed early stage Parkinson's Disease who meet DSM-5 criteria for a depressive or anxious disorder and meet all other inclusion and exclusion criteria at screening. After baseline assessments, participants will complete preparation sessions with trained facilitators followed by an initial drug administration session during which they will receive a low-moderate dose (10 mg) oral psilocybin in a supervised setting with safety monitoring by facilitators and a physician. Participants who do not experience significant adverse events during or following the session will complete a second drug administration session approximately two weeks later during which they will receive a moderate-high dose (25 mg) oral psilocybin. The second session will involve the same procedures and level of monitoring as the first. Participants will subsequently complete multiple follow-up sessions to assess PD motor symptoms, non-motor symptoms, and function. They will also complete integration sessions with facilitators to provide psychological support. Follow-up will continue to 3 months after the second psilocybin administration session. Primary endpoints will assess safety, tolerability and feasibility of study procedures. Exploratory efficacy endpoints will assess changes in depressive symptoms, anxious symptoms, and related measures of function/quality of life.
The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy for depression and anxiety in people with Parkinson's disease.