Clinical trial NCT06455293: Psilocybin Therapy for Depression in Parkinson's Disease
Official title: The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Parkinson Disease
Depression
Keywords: Parkinson Disease
Depression
Psilocybin
Psilocybin therapy
Movement disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2024-06-12
Enrollment: 60
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All participants will receive two doses of psilocybin ranging from low ("microdose") to high. All participants will receive three psilocybin preparation sessions, two administration sessions of a single dose of psilocybin within a therapeutic environment (6-8 hours), five integration sessions, and two follow up visits. All drugs will be orally administered during the dosing sessions. The study procedures will follow best practices for administering psilocybin in clinical trials.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease
timeFrame: Baseline to 30 days after first drug dose
Secondary outcomes:
measure: Changes in depression severity
timeFrame: 7 days after first drug dose to 90 days after second drug dose
measure: Changes in clinician-assessed depression
timeFrame: Baseline to 90 days after second drug dose
measure: Changes in anxiety
timeFrame: Baseline to 90 days after second drug dose
measure: Changes in PD symptom severity
timeFrame: Baseline to 90 days after second drug dose
measure: Changes in Quality of Life
timeFrame: Baseline to 90 days after second drug dose
measure: Changes in cognitive performance
timeFrame: Baseline to 90 days after second drug dose
measure: Safety and tolerability of psilocybin therapy for depression in people with PD
timeFrame: Baseline to 90 days after second drug dose
measure: Changes in clinician-rated psychotic symptoms
timeFrame: Baseline to 90 days after second drug dose
measure: Subjective effects of psilocybin
timeFrame: Up to 30 and 60 days after Baseline
measure: Participant-reported acceptability of study procedures
timeFrame: 30 days after second drug dose
measure: Care partner/support person reported distress
timeFrame: Baseline to 90 days after second drug dose
Other outcomes:
measure: Changes in peripheral inflammatory markers (exploratory)
timeFrame: Baseline to 90 days after second drug dose
measure: Changes in brain structure and function (exploratory)
timeFrame: Baseline to 90 days after second drug dose
measure: Changes in participant reported pain (exploratory)
timeFrame: Baseline to 90 days after second drug dose
measure: Changes in participant reported sleep (exploratory)
timeFrame: Baseline to 90 days after second drug dose
measure: Changes in sleep parameters, physical activity, body temperature, and heart rate (exploratory)
timeFrame: Baseline to 30 days after first drug dose
measure: Evaluation of treatment expectations (exploratory)
timeFrame: Baseline
measure: Evaluation of masking procedures (exploratory)
timeFrame: Up to 30 and 60 days after Baseline
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Joshua Woolley, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Ellen Bradley, MD
role: PRINCIPAL_INVESTIGATOR
References: