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

Plain-Language Summary

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?
No. There is no cost to participate. Study-related care and treatment are provided at no charge.
How long does the trial last?
This Phase 2 trial is estimated to last approximately 2 years and 9 months.

View on ClinicalTrials.gov