CompletedPhase 2

Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease

NCT04932434 · PDP1 · Joshua Woolley, MD, PhD

Closed to entry

Status

Not accepting participants

Phase 2

Phase

Target enrolment

Study sites

1 US states

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Parkinson's Disease (PD) symptom severity
Measured over Baseline to 30 days following last drug dose
Suicide Risk
Measured over Baseline to 30 days following last drug dose
Psychotic symptoms
Measured over Baseline to 30 days following last drug dose
Psychotic symptoms
Measured over Baseline to 30 days following last drug dose
Cognitive Safety
Measured over Baseline to 30 days following last drug dose
Caregiver/support person-reported distress
Measured over Baseline to 90 days following last drug dose
Participant-reported subjective experience
Measured over Measured on each drug administration session day, following drug dose
Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD
Measured over Baseline to 3 months following last drug dose
Recruitment rate
Measured over Baseline to 3 months following last drug dose
Retention rate
Measured over Baseline to 3 months following last drug dose
Treatment Satisfaction of psilocybin therapy for depression and anxiety in people with PD
Measured over Baseline to 3 months following last drug dose

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

40 Years to 75 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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

Where

1 study site

Facility	City	Region	Country
University of California, San Francisco	San Francisco	California	United States

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT04932434 on ClinicalTrials.gov →

Last updated in the registry 2025-01-01. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Psilocybin

Indication

Recruiting in

California115

All 4 trials from Joshua Woolley, MD, PhD →