Summary

Eligibility
for people ages 40-75 (full criteria)
Dates
study started
estimated completion
Principal Investigator
by Joshua Woolley, MD/PhD
Photo of Joshua Woolley
Joshua Woolley

Description

Summary

The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy for depression and anxiety in people with Parkinson's disease.

Official Title

Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study

Details

This is an open-label single-arm pilot study of oral psilocybin therapy for depression and anxiety in people with Parkinson's Disease (PD). The primary goal is to examine safety, tolerability, and feasibility of the intervention in this patient population. We will enroll ten people ages 40 to 75 with clinically diagnosed early stage Parkinson's Disease who meet DSM-5 criteria for a depressive or anxious disorder and meet all other inclusion and exclusion criteria at screening. After baseline assessments, participants will complete preparation sessions with trained facilitators followed by an initial drug administration session during which they will receive a low-moderate dose (10 mg) oral psilocybin in a supervised setting with safety monitoring by facilitators and a physician. Participants who do not experience significant adverse events during or following the session will complete a second drug administration session approximately two weeks later during which they will receive a moderate-high dose (25 mg) oral psilocybin. The second session will involve the same procedures and level of monitoring as the first. Participants will subsequently complete multiple follow-up sessions to assess PD motor symptoms, non-motor symptoms, and function. They will also complete integration sessions with facilitators to provide psychological support. Follow-up will continue to 3 months after the second psilocybin administration session. Primary endpoints will assess safety, tolerability and feasibility of study procedures. Exploratory efficacy endpoints will assess changes in depressive symptoms, anxious symptoms, and related measures of function/quality of life.

Keywords

Parkinson Disease Depression Anxiety Psilocybin Psilocybin therapy Movement disorder Depressive Disorder Anxiety Disorders N,N-Dimethyltryptamine

Eligibility

You can join if…

Open to people ages 40-75

  • Age 40 to 75
  • Comfortable speaking and writing in English
  • Clinically diagnosed early stage Parkinson's Disease (Hoehn and Yahr Stage 1-3 during an "off" period) who meet DSM-5 criteria for a depressive or anxious disorder and meet all other inclusion and

You CAN'T join if...

at screening

Exclusion Criteria:

  • 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 (NMDAR) antagonists, antipsychotics, and stimulants
  • A health condition that makes this study unsafe or unfeasible, determined by study physicians

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
NCT04932434
Phase
Phase 2
Study Type
Interventional
Last Updated