Recruiting
Psilocybin Therapy for Depression in Parkinson's Disease
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
ClinicalTrials.gov IDNCT06455293
PhasePHASE2
Enrollment60
SponsorJoshua Woolley, MD, PhD
Age40 Years
SexALL
Conditions studied
Parkinson Disease, Depression
About this study
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
Interventions
- Drug: Psilocybin — Single dose of psilocybin ranging from low ("microdose") to high delivered orally in two separate drug administration sessions with psychological support and monitoring.
- Drug: Pimavanserin — Participants will receive either pimavanserin or placebo during their drug administration sessions.
Primary outcomes
- Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease (Baseline to 30 days after first drug dose)
Eligibility information
Inclusion Criteria:
* Age 40 to 80
* 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)
* Currently experiencing depressive symptoms
* Able to attend all in-person visits at UCSF as well as virtual visits
* Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating
Exclusion Criteria:
* Psychotic symptoms involving loss of insight
* Significant cognitive impairment
* Regular use of medications that may have problematic interactions with psilocybin
* A health condition that makes this study unsafe or unfeasible, determined by study physicians
Study locations
- University of California, San Francisco, San Francisco, California 94143 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.