Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joshua Woolley, MD/PhD
• Treatments: N,N-Dimethyltryptamine; Psilocybin

Criteria

Inclusion Criteria:

• 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 exclusion criteria at screening

• Currently experiencing depression and/or anxiety (a formal diagnosis is not necessary)

• Able to attend all in-person visits at UCSF as well as virtual visits

• Have a care partner/support person available throughout the study

• Have an established primary care provider, neurologist, or psychiatrist

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