Recruiting
Phase 2

Psilocybin

Sponsor:

Joshua Woolley, MD, PhD

Code:

NCT06455293

Conditions

Parkinson Disease

Depression

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Psilocybin

Pimavanserin

Study Details

Brief 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.

Conditions

Parkinson Disease

Depression

Study ID

NCT06455293

Start date

Aug 19, 2024

Status verified date

May, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Psychotic symptoms involving loss of insight
  • Significant cognitive impairment
  • Regular use of medications that may have problematic interactions with psilocybin
  • A health condition that makes this study unsafe or unfeasible, determined by study physicians

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psilocybin Administration Session 1

Participants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after.

experimental: Psilocybin Administration Session 2

Participants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after.

Interventions

Psilocybin

Single dose of psilocybin ranging from low ("microdose") to high delivered orally in two separate drug administration sessions with psychological support and monitoring.

Pimavanserin

Participants will receive either pimavanserin or placebo during their drug administration sessions.

Primary outcome measure

  • Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease [ Time Frame: Baseline to 30 days after first drug dose ]

Central Contacts and Locations

Central contacts

Brigette Sosa

(415) 935-3489pdp2@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Brigette Sosa

(415) 935-3489pdp2@ucsf.edu

Kimberly Sakai

pdp2@ucsf.edu

Principal Investigator:

Joshua Woolley, MD,PhD

More Information

Sponsor

Joshua Woolley, MD, PhD

Last update posted

Aug 7, 2026

Last verified

May, 2026

Keywords

  • Parkinson Disease
  • Depression
  • Psilocybin
  • Psilocybin therapy
  • Movement disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Joshua Woolley, MD, PhD on 2026-08-07.