Assistant Professor of Psychiatry; Assistant Professor, Neurology
The PSI-PD Study
Psilocybin for Depression in Parkinson’s disease
This is a clinical trial funded by the Michael J. Fox Foundation. The purpose of this study is to understand whether people with Parkinson’s Disease and depression have improvement in their symptoms after psilocybin therapy. We are looking for volunteers with Parkinson's disease and symptoms of depression (age 40–80).
To find out more about this trial, please email psilocybinpd@yale.edu or fill out this survey.
HIC #2000042396
The Efficacy of Psilocybin Therapy for Depression in Parkinson’s Disease
Why are we conducting this research?
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Depression affects around half of people with Parkinson's disease and significantly adds to the burden of the disease. Existing antidepressants don't always work well for depression in Parkinson's disease, and new treatment options are needed. Psilocybin — the active ingredient in "magic mushrooms" — has shown promise in improving depression in people with cancer and other medical conditions. This study will test, for the first time in a controlled clinical trial, whether psilocybin can safely and effectively treat depression in people with Parkinson's disease.
What's involved?
The study involves about 15 visits (a mix of in-person and remote) over roughly 6 months. You would receive two psilocybin dosing sessions, each done in person at our research site with clinical staff and a trained facilitator present throughout the day. Before and after each dosing session, you'll have preparation and follow-up visits — including interviews, questionnaires, blood draws, and physical exams — to monitor your health and track your symptoms.
You will receive compensation for your participation in this study, and travel accommodations are available for those traveling from out of town. Taking part could help researchers discover new treatments for depression in Parkinson's disease.
Eligibility:
- Between 40 and 80 years old
- Diagnosed with Parkinson's disease
- Currently experiencing symptoms of depression (a doctor's diagnosis is not required)
- Able to come to the Yale University campus for in-person visits
Demonstration Video
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See what a session looks like:
Photos/Gallery
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Where are we based?
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In-person visits will take place at Yale's Temple Medical Center and Yale Psychiatric Hospital in New Haven.
Meet the team
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George D. and Esther S. Gross Professor of Psychiatry; Co-Director, Yale New Haven Hospital Interventional Psychiatry Service; Director, Yale Depression Research Program
Associate Professor; Clinical Chief of Movement Disorders, Neurology ; Director , Comprehensive Parkinson Disease Program
Frequently Asked Questions
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- Is this legal / FDA-approved?
Psilocybin is not currently FDA-approved for any medical or therapeutic use. It is being studied here as an experimental treatment, under an IRB-approved research protocol.
- What happens during a psilocybin session?
You'll take a capsule containing psilocybin. You'll stay at the research unit for the full day, with a trained facilitator present the whole time and study medical staff available. You can rest, listen to music, journal, draw, meditate, stretch, dance, or just be. You are welcomed to do whatever helps you through the experience. You won't be able to leave the dosing room until you've been cleared by a study clinician.
- Will I know what dose or medication I'm getting?
All participants will receive psilocybin, but neither you nor the study team treating you that day will know your exact dose. This is done to keep the results scientifically reliable. You'll be told the details after everyone in the study has finished participating.
- Is it safe?
As with any study drug, there are risks, including some that can be serious, such as changes in heart rate/blood pressure, hallucinations, or (rarely) more severe reactions. Study staff monitor you closely throughout each session, and we will ensure that you are safe to leave. The full list of risks is reviewed in detail during informed consent, before you decide whether to participate.
- Will this change my regular Parkinson's care?
No. Your usual doctors will keep treating you as normal, and the study team won't change your Parkinson's medications or treatment plan (aside from any temporary adjustments needed for study eligibility, which would be discussed with you and your clinical team first).
- Can I change my mind after I start?
Yes. Participation is voluntary and you can withdraw at any time, for any reason, without affecting your regular medical care.
- Will I be compensated?
You will receive compensation for your participation in this study, and travel accommodations are available for those traveling from out of town.
- Who can I contact with questions?
Email us at psilocybinpd@yale.edu. You can also reach the Yale IRB directly at (203) 785-4688 or hrpp@yale.edu if you have questions about your rights as a research participant.