Psilocybin therapy for treating depression in Parkinson's disease
Official title: The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
Run by University of California, San Francisco · NCT06455293 · Data updated 2026-11-12
This study is testing if psilocybin therapy can help people with Parkinson's disease who are also dealing with depression feel better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years to 80 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of California, San Francisco Academic / other |
| Locations | 1 site (San Francisco, California) |
| Status | Recruiting |
| Started | August 19, 2024 |
| Main results expected | June 2027 |
| Study ends | June 2028 |
| Registry record updated | August 7, 2026 |
| Trial ID | NCT06455293 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals aged 40 to 80 with diagnosed early to moderate stage Parkinson's disease and moderate to severe depression.
✕Probably not a fit
Patients with significant cognitive impairment or psychotic symptoms may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial investigates the efficacy of oral psilocybin therapy in individuals with Parkinson's disease who are experiencing depression. The study will enroll 60 participants aged 40 to 80 with early to moderate stage Parkinson's disease and moderate or greater depression severity. Participants will undergo two drug administration sessions with varying doses of psilocybin, accompanied by psychotherapy sessions before and after each administration. Clinical assessments, neuroimaging, and biomarker analysis will be conducted to evaluate changes in depression and other symptoms over a follow-up period of three months.
Why it matters
Potential benefit: If successful, this therapy could significantly improve depressive symptoms in patients with Parkinson's disease, enhancing their overall quality of life.
How similar studies have gone: While psilocybin therapy is a novel approach for this specific population, similar studies have shown promising results in treating depression with psilocybin in other contexts.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of California, San Francisco
San Francisco, California, United States Recruiting
Study contacts
- Principal investigator: Joshua Woolley, MD,PhD — University of California, San Francisco
- Study coordinator: Brigette Sosa
- Email: pdp2@ucsf.edu
- Phone: (415) 935-3489
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.