About the study
Depression is among the most common non-motor features of Parkinson's disease and among the least well treated. This randomized controlled trial asks whether psilocybin therapy improves depression in people living with early-to-moderate Parkinson's.
Participants complete two drug administration sessions, receiving oral psilocybin at doses ranging from microdose to high, in a medically monitored setting with psychotherapeutic support. Psychotherapy sessions precede and follow each administration. Alongside depression, the study tracks Parkinson's motor and non-motor symptoms, cognitive performance, and quality of life, with follow-up continuing three months past the second session. Results will be combined with those of a parallel trial at UCSF.
Is this study a fit?
The study team makes the final decision after screening. Final eligibility is determined in clinical screening, never by this page.
Who may be eligible
- Adults 40 to 80
- Neurologist-diagnosed idiopathic Parkinson's disease, Hoehn and Yahr stage 1–3 during an "on" phase
- Beck Depression Inventory-II score of 20 or higher at baseline, indicating moderate or greater depression
- No medication changes or major surgery anticipated during the treatment period
- A primary care provider, neurologist, or psychiatrist actively managing care and available to our medical monitor
- Willing to observe the study's medication, alcohol, nicotine, cannabis, and caffeine restrictions around each session
What would rule someone out
- Any indication of parkinsonism other than idiopathic Parkinson's disease
- Montreal Cognitive Assessment score below 24
- Symptomatic orthostatic hypotension
- History of a schizophrenia spectrum disorder, other psychotic disorder, or bipolar disorder — including a first-degree relative with a schizophrenia spectrum disorder
- Moderate or severe alcohol or drug use disorder within the past two years
- Clinically significant psychedelic use within the past six months
- ECT or TMS within the past 30 days
- Elevated blood pressure, tachycardia, bradycardia, angina, stroke within the past year, or QTc above 450
- Hepatic dysfunction, renal insufficiency, epilepsy, or supplemental oxygen requirement
- Inability to discontinue medications that risk serotonin syndrome or interact with psilocybin metabolism
Final eligibility is determined in clinical screening, never by this page.
Does this sound like you? The next step is a short, no-commitment inquiry.
Check if I'm a fitStudy team
Study facts
Phase 2 · Randomized controlled · Target enrollment 40 · Sponsor: Yale University, with the Michael J. Fox Foundation for Parkinson's Research · Site: Yale University, New Haven · PI: Sophie Holmes, Ph.D.
Contact & location
Inquire about this study
Sending an inquiry does not put you in a study and does not commit you. Whether a study is a fit is decided later, in screening.
- 1Send an inquiry
- 2A team member contacts you to answer your questions and, if you'd like, do a short phone pre-screen
- 3Screening, if it looks like a fit
Clinicians: use Refer a Patient. Not sure what happens after you write? What to expect if you inquire.
Contact the study team
- Phone
- (203) 444-1795
- Location
- Enact Research Collaborative
40 Temple St., 4th Floor, Suite 4C
New Haven, CT 06510
Registry title: The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease. View NCT07610369 on ClinicalTrials.gov (opens in a new tab)