Clinical TrialDepressive DisordersPsilocybinPsilocybinCompleted

Psilocybin Therapy for Depression and Anxiety in Parkinson’s Disease (PDP)

Open-label, single-arm pilot study (n=12) of two supervised oral psilocybin sessions (10 mg then 25 mg, ~2 weeks apart) for depression and anxiety in people with Parkinson's disease; primary outcomes safety, tolerability, and feasibility.

Target Enrollment
12 participants
Study Type
Phase II interventional
Design
Non-randomized

Detailed Description

This open-label single-group pilot study tests the safety, tolerability, and feasibility of psilocybin therapy in people with early-stage Parkinson's disease who have depressive or anxious disorders.

Participants receive preparation sessions, then a first supervised 10 mg oral psilocybin session; those without significant adverse events may receive a second supervised 25 mg session about two weeks later. Psychological support and medical monitoring are provided during dosing.

Follow-up visits continue to three months after the second dosing to assess safety, Parkinson's and psychiatric symptoms, and feasibility of procedures; primary endpoints focus on adverse events and tolerability.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Therapeutic Protocol

support

Study Arms & Interventions

Psilocybin therapy

experimental

Open-label single-group psilocybin therapy with preparation and integration sessions; one or two oral dosing sessions approximately two weeks apart.

Interventions

  • Psilocybin10 mg
    via Oral• single dose

    First session: 10 mg oral psilocybin with psychological support and monitoring.

  • Psilocybin25 mg
    via Oral• single dose

    Second session (conditional, ~2 weeks later): 25 mg oral psilocybin with psychological support and monitoring.

Participants

Ages
40 – 75
Sexes
Male & Female

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

Study Details

Locations

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

Your Library