NCT06455293 Psilocybin Therapy for Depression in Parkinson's Disease
| NCT ID | NCT06455293 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Joshua Woolley, MD, PhD |
| Condition | Parkinson Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-08-19 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2024-08-19 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Joshua Woolley, MD,PhD
PRINCIPAL INVESTIGATOR
University of California, San Francisco
Frequently Asked Questions
Who can join the NCT06455293 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, up to 80 Years, studying Parkinson Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06455293 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06455293 currently recruiting?
Yes, NCT06455293 is actively recruiting participants. Contact the research team at pdp2@ucsf.edu for enrollment information.
Where is the NCT06455293 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT06455293 clinical trial?
NCT06455293 is sponsored by Joshua Woolley, MD, PhD. The principal investigator is Joshua Woolley, MD,PhD at University of California, San Francisco. The trial plans to enroll 60 participants.
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