The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
Yale University
Summary
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
Description
This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. Investigators will enroll participants with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an "on" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of ora…
Eligibility
- Age range
- 40–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Able to understand and provide informed consent * Comfortable speaking and writing in English * Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an "on" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect) * Have no changes in medication or major surgical procedures anticipated for treatment duration * Have a score \>/=20 on the Beck Depression Inventory-2 (BDI-2), consistent with moderate or greater depressive symptom severity, at Baseline. * For people who ca…
Interventions
- DrugPsilocybin (drug)
Single dose of psilocybin ranging from low ("microdose") to high delivered orally with psychological support and monitoring
- DrugPsilocybin (drug)
Single dose of psilocybin ranging from low ("microdose") to high delivered orally with psychological support and monitoring
Location
- Yale UniversityNew Haven, Connecticut