The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

Part of paid clinical trials in New Haven, Connecticut.

Sponsor
Yale University
Study ID
NCT07610369
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) — DRUG
    Single dose of psilocybin ranging from low ("microdose") to high delivered orally with psychological support and monitoring
  • Psilocybin (drug) — DRUG
    Single dose of psilocybin ranging from low ("microdose") to high delivered orally with psychological support and monitoring

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

First listed
May 28, 2026
Start date
Jul 31, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2030

Study Design

Enrollment
40 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 in a 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 in a monitored setting with preparation sessions before and integration sessions after.

Primary Outcome Measure

Change in depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline to 30 days after first drug dose ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Yale UniversityNew HavenConnecticut06510
Sophie Holmes, PhD
[email protected]
203-685-4066
Sophie Holmes, PhD (PRINCIPAL_INVESTIGATOR)
Gerard Sanacora, MD (PRINCIPAL_INVESTIGATOR)

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By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
Yale University· New Haven, CT

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