Clinical TrialDepressive DisordersPsilocybinRecruiting

Psilocybin Therapy for Depression in Parkinson’s Disease (PDP2)

This randomised controlled trial (n=60) will assess the efficacy of oral psilocybin therapy for depression in individuals with Parkinson’s disease.

Target Enrollment
60 participants
Study Type
Phase II interventional
Design
Randomized, quadruple Blind

Detailed Description

Randomised, parallel-design trial enrolling 60 people with Parkinson's disease and clinically significant depressive symptoms to evaluate psilocybin therapy.

Participants receive three preparation sessions, two supervised oral psilocybin administration sessions (one dose per session; 6–8 hours each), five integration sessions, and follow-up visits to 3 months after the second session.

Outcomes include measures of depression, motor and non-motor PD symptoms, quality of life, neuroimaging and blood-based biomarkers, and safety/tolerability.

Study Protocol

Preparation

3 sessions

Dosing

2 sessions
480 min each

Integration

5 sessions

Therapeutic Protocol

Manualized psychotherapy included

Study Arms & Interventions

Psilocybin

experimental

Oral psilocybin administered in two supervised sessions with preparatory and integration therapy.

Interventions

  • Psilocybin
    via Oral• single dose• 2 doses total

    Dose range from low (microdose) to high per protocol; randomized dose assignment; one dose per administration session; medically supervised (6–8 h).

Participants

Ages
40 – 80
Sexes
Male & Female

Inclusion Criteria

  • 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
  • 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

  • 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 Details

  • Status
    Recruiting
  • Phase
    Phase II
  • Type
    interventional
  • Design
    Randomizedquadruple Blind
  • Target Enrollment60 participants
  • Timeline
    Start: 2024-07-01
    End: 2028-06-30
  • Compound
    Psilocybin
  • Topic
    Depressive Disorders

Locations

University of California, San Francisco — San Francisco, California, United States

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