Not Yet RecruitingPhase 2

The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

United States40 participantsStarted 2026-06

Plain-language 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.

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 can become pregnant: agree to use highly effective contraception from entry into the trial through Day B30 assessments (4 weeks after the second psilocybin administration session) and agree to not breastfeed. Acceptable methods of contraception are: An intrauterine device (IUD), hormone-based contraceptives (birth control pills) , condoms (internal or external) must be used with another method (other than spermicide), and complete abstinence from sexual activity that could result in pregnancy. * Agree that for one week preceding each psilocybin session, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and assessed for safety. Agree to abstain from all tobacco and nicotine use for the duration of the study. * Agree to consume approximately th…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This is a Phase 2 trial testing psilocybin for depression in people with Parkinson's disease — given that it's still in the early phases of testing, what do we know so far about whether psilocybin is safe for someone with Parkinson's, and are there any interactions with my current Parkinson's medications I should be concerned about?
2The trial isn't recruiting yet — based on my current situation, do you think it makes sense to wait for this study to open, or would starting a more established treatment for my depression now be a better path?
3The trial is measuring depression using a scale called the MADRS — can you explain what that means for how my progress would be tracked, and how would we know if my depression was getting worse during the study so we could act quickly?
4Psilocybin can cause intense psychological experiences — given that I already have Parkinson's disease, do you think I'm in a good position physically and emotionally to go through that kind of session, and what support would be in place during and after?
5If I were to eventually enroll in this trial, how might participating affect my access to other depression treatments, and what would my options be if psilocybin therapy didn't help my symptoms?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)

Timeframe: Baseline to 30 days after first drug dose

Trial details

NCT IDNCT07610369

SponsorYale University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2030-06

Contact for this trial

Sophie Holmes, PhD

203-685-4066 sophie.holmes@yale.edu

View on ClinicalTrials.gov More Depression trials

Who can participate

Age range

40 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.