Psilocybin Therapy for Depression in Parkinson's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Psilocybin, Pimavanserin.
- Who it may be relevant to
- Registry conditions: Parkinson Disease, Depression. Basic parameters: 40 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
Overview
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. After posting of these trial results, this data will be combined with the data from the trial at Yale University (NCT07610369) for publication purposes.
Interventions
- Drug Psilocybin
Single dose of psilocybin ranging from low ("microdose") to high delivered orally in two separate drug administration sessions with psychological support and monitoring. - Drug Pimavanserin
Participants will receive either pimavanserin or placebo during their drug administration sessions.
Primary outcome measures
- 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]
Secondary outcome measures (10)
- Changes in depression severity [Time frame: 7 days after first drug dose to 90 days after second drug dose]
- Changes in clinician-assessed depression [Time frame: Baseline to 90 days after second drug dose]
- Changes in anxiety [Time frame: Baseline to 90 days after second drug dose]
- Changes in PD symptom severity [Time frame: Baseline to 90 days after second drug dose]
- Changes in Quality of Life [Time frame: Baseline to 90 days after second drug dose]
- Changes in cognitive performance [Time frame: Baseline to 90 days after second drug dose]
- Safety and tolerability of psilocybin therapy for depression in people with PD [Time frame: Baseline to 90 days after second drug dose]
- Changes in clinician-rated psychotic symptoms [Time frame: Baseline to 90 days after second drug dose]
- Subjective effects of psilocybin [Time frame: Up to 30 and 60 days after Baseline]
- Participant-reported acceptability of study procedures [Time frame: 30 days after second drug dose]
Eligibility 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 (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
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of California, San Francisco — San Francisco
Identifiers
NCT: NCT06455293 · IRB#20-32641