Psilocybin for Parkinson's (NCT06455293)
Reduce depressive symptoms in Parkinsons
- Trial ID
- NCT06455293
- Official Title
- The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
- Goal
- Reduce depressive symptoms in Parkinsons
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Joshua Woolley, MD, PhD
- Study Type
- INTERVENTIONAL
- Enrollment
- 60 participants
- Conditions
- Parkinson Disease, Depression
- Interventions
- Psilocybin, Pimavanserin
Summary For Families
The goal is to see if psilocybin can ease depression in people with Parkinson's, by loosening rigid negative thought patterns and shifting brain network activity that underlies mood. Participants receive a guided dose of psilocybin, a psychedelic that activates serotonin 2A receptors to briefly reset brain networks and support emotional processing; it does not directly increase dopamine or replace levodopa, though the team avoids combining it with drugs that affect serotonin. Eligible participants are age 40 to 80 with neurologist-diagnosed idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3 in an "on" phase, currently experiencing depressive symptoms, able to attend UCSF visits, and managed by a provider, while people with psychotic symptoms, significant cognitive impairment, or regular use of meds that interact with psilocybin are excluded.
Locations
- University of California, San Francisco, San Francisco, California, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Psilocybin. The goal is to see if psilocybin can ease depression in people with Parkinson's, by loosening rigid negative thought patterns and shifting brain network activity that underlies mood. Participants receive a guided dose of psilocybin, a psychedelic that activates serotonin 2A receptors to briefly reset brain networks and support emotional processing; it does not directly increase dopamine or replace levodopa, though the team avoids combining it with drugs that affect serotonin. Eligible participants are age 40 to 80 with neurologist-diagnosed idiopathic Parkinson's at Hoehn and Yahr stages 1 to 3 in an "on" phase, currently experiencing depressive symptoms, able to attend UCSF visits, and managed by a provider, while people with psychotic symptoms, significant cognitive impairment, or regular use of meds that interact with psilocybin are excluded.
- Who can participate?
- Participants must be between 40 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- Does it cost anything to join?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 2 years and 9 months.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.
- How many visits does this trial involve?
- Participants will complete two drug administration sessions.