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CompletedPhase 2Results posted

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
12
Target enrolment
1
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

  • Movement Disorder Society-sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS)

    Measured over 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

  • Columbia Suicide Severity Rating Scale (C-SSRS)

    Measured over 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

  • Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)

    Measured over 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

  • Psychosis and Hallucinations in Parkinson's Disease Questionnaire (PsycH-Q)

    Measured over On day of first drug dose (which takes place 2-4 weeks after enrollment); On day of, and 11, 18, and 25 days following second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

  • Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q)

    Measured over 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7, 30, and 90 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)

  • 11-Dimensional Altered States of Consciousness Rating Scale (11D-ASC)

    Measured over Measured on each drug administration session day, following drug dose

  • Incidence of Adverse Events

    Measured over 0-24 hours, 1-7 days, 8-14 days, 15-30 days, and 31-90 days after drug administration

  • Retention Rate

    Measured over 90 days following last drug dose

  • Treatment Satisfaction Questionnaire (TSQ)

    Measured over 30 days 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

FacilityCityRegionCountry
University of California, San FranciscoSan FranciscoCaliforniaUnited 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. The registry also holds the most current version of everything above.

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 2026-09-03. Registry records change; this page reflects the data build of 2026-10-06.

Related

Where this trial sits