Summary

Eligibility
for people ages 40-80 (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Joshua Woolley, MD,PhD
Headshot of Joshua Woolley
Joshua Woolley

Description

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.

Official Title

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

Details

This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. We will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an "on" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose somewhere between 1-25 mg of oral psilocybin in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments, neuroimaging, non-invasive brain stimulation, and peripheral blood draws will be used to quantify changes in depression, other non-motor and motor symptoms of PD, quality of life, and selected neural and blood-based biomarkers at multiple time points. Follow-up will continue to 3 months after the second session. Primary endpoints will evaluate efficacy, safety, and tolerability of study procedures.

Keywords

Parkinson Disease, Depression, Psilocybin, Psilocybin therapy, Movement disorder, Depressive Disorder, N,N-Dimethyltryptamine, Psilocybin Administration Session 1, Psilocybin Administration Session 2

Eligibility

You can join if…

Open to people ages 40-80

  • 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

You CAN'T join if...

  • Psychotic symptoms involving loss of insight
  • Significant cognitive impairment
  • Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate tricyclic antidepressants, antipsychotics, and stimulants
  • A health condition that makes this study unsafe or unfeasible, determined by study physicians

Location

  • UCSF
    San Francisco California 94143 United States

Lead Scientist at UCSF

  • Joshua Woolley, MD,PhD
    Dr. Josh Woolley is an Associate Professor in Residence in the Department of Psychiatry and Behavioral Sciences at the University of California, San Francisco (UCSF) as well as a staff psychiatrist in Mental Health at the San Francisco Veterans Affairs Medical Center (SFVAMC). He is Board Certified in Psychiatry by the American Board of Psychiatry and Neurology.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Joshua Woolley, MD, PhD
ID
NCT06455293
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 60 study participants
Last Updated