Psilocybin Therapy for Depression in Parkinson's Disease
- Registration Number
- NCT06455293
- Lead Sponsor
- Joshua Woolley, MD, PhD
- 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.
- Detailed Description
This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. We will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an "on" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low ("microdose") to high in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments, neuroimaging, non-invasive brain stimulation, and peripheral blood draws will be used to quantify changes in depression, other non-motor and motor symptoms of PD, quality of life, and selected neural and blood-based biomarkers at multiple time points. Follow-up will continue to 3 months after the second session. Primary endpoints will evaluate efficacy, safety, and tolerability of study procedures.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Psilocybin Administration Session 1 Psilocybin 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. Psilocybin Administration Session 2 Psilocybin 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 Measures
Name Time Method Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease Baseline to 30 days after first drug dose Changes in depression as measured by the Beck Depression Inventory-2 (BDI-2)
- Secondary Outcome Measures
Name Time Method Participant-reported acceptability of study procedures 30 days after second drug dose Measured by the study-specific Treatment Satisfaction Questionnaire-Participant (TSQ-P)
Care partner/support person reported distress Baseline to 90 days after second drug dose Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)
Changes in depression severity 7 days after first drug dose to 90 days after second drug dose Measured by Beck Depression Inventory-2 (BDI-2) scores
Changes in Quality of Life Baseline to 90 days after second drug dose Measured by the 36-item Short Form survey (SF-36)
Changes in clinician-assessed depression Baseline to 90 days after second drug dose Measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
Changes in anxiety Baseline to 90 days after second drug dose Measured by the Parkinson Anxiety Scale (PAS)
Changes in PD symptom severity Baseline to 90 days after second drug dose Measured by the Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Changes in cognitive performance Baseline to 90 days after second drug dose Measured by a multi-task assessment
Safety and tolerability of psilocybin therapy for depression in people with PD Baseline to 90 days after second drug dose Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
Changes in clinician-rated psychotic symptoms Baseline to 90 days after second drug dose Measured by the Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)
Subjective effects of psilocybin Up to 30 and 60 days after Baseline Measured by the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
Trial Locations
- Locations (2)
University of California, San Francisco
🇺🇸San Francisco, California, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States