Psilocybin Therapy for Depression in Parkinson's Disease

Part of paid clinical trials in San Francisco, California.

Sponsor
Joshua Woolley, MD, PhD
Study ID
NCT06455293
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Psilocybin — DRUG
    Single dose of psilocybin ranging from low ("microdose") to high delivered orally in two separate drug administration sessions with psychological support and monitoring.
  • Pimavanserin — DRUG
    Participants will receive either pimavanserin or placebo during their drug administration sessions.

Study Details

The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.

Key Dates

Start date
Aug 19, 2024
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Brigette Sosa
[email protected]
415-935-3489
Kimberly Sakai
[email protected]
Joshua Woolley, MD,PhD (PRINCIPAL_INVESTIGATOR)
Ellen Bradley, MD (SUB_INVESTIGATOR)

Find similar trials in San Francisco, CA

By condition
DepressionParkinson's disease
By specialty
PsychiatryMental healthBehavioral healthNeurologyBrain disorders
By research site
University of California, San Francisco· San Francisco, CA

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