The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-80
SponsorYale University
About this trial
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to understand and provide informed consent
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)
Have no changes in medication or major surgical procedures anticipated for treatment duration
Disqualifiers
Any indication of forms of parkinsonism other than idiopathic Parkinson's disease.
Cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score <24.
Symptomatic orthostatic hypotension.
Currently receiving electroconvulsive therapy (ECT) or treatment via transcranial magnetic stimulation (TMS). Previous treatment with ECT and/or TMS is permitted; last treatment must be at least 30 days prior to entry into this trial.
Trial design
Design model
Parallel
Treatments tested in this trial
Psilocybin (drug)
DrugSingle dose of psilocybin ranging from low ("microdose") to high delivered orally with psychological support and monitoring
Psilocybin (drug)
DrugSingle dose of psilocybin ranging from low ("microdose") to high delivered orally with psychological support and monitoring
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Psilocybin Administration Session 1Experimental treatment 1 intervention
Group B: Psilocybin Administration Session 2Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS is a 10-item clinician-administered scale used to measure the severity of depressive symptoms. Total scores range from 0 to 60 with higher scores indicating more severe depression.
Time frame
Baseline to 30 days after first drug doseSecondary outcomes
1
Adverse Events
Incidence, severity, and frequency of all Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
Time frame
Baseline to 90 days after second drug dose2
Changes in clinician-rated psychotic symptoms as measured by the Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)
The eSAPS-PD is a clinician-administered scale used to track Parkinson's Disease symptom severity. Scores range from 25 to 125, where higher scores indicate more impairment.
Time frame
Baseline to 90 days after second drug dose3
Subjective effects of psilocybin as measured by the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
The 5D-ASC is a patient-reported scale used to measure the intensity of an experience during altered states of conciousness. Scores range from 0 to 100, where higher scores indicate more intense psychedelic effects.
Time frame
Up to 30 and 60 days after Baseline4
Suicidality as measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS is a clinician-administered scale used to assess suicide risk. Scores range from 0 to 6, where higher scores indicate more severe suicide risk.
Time frame
Baseline to 90 days after second drug doseOther outcomes
1
Changes in sleep parameters as measured using passive sensing via an Oura ring (exploratory)
The Oura ring is a wearable device that synchronizes with a smartphone application. It records sleep by combining infrared photoplethysmography (PPG) sensors, a sensitive accelerometer, and temperature monitoring to track heart rate, movement, and body temperature, which are analyzed by machine learning algorithms to determine sleep stages and patterns.
Time frame
Baseline to 30 days after the second drug dose2
Changes in physical activity as measured using passive sensing via an Oura ring (exploratory)
The Oura ring is a wearable device that synchronizes with a smartphone application. It records physical activity using using a combination of a 3D accelerometer, heart rate sensors, and activity algorithms to track movement, steps, calories burned, and exercise intensity.
Time frame
Baseline to 30 days after the second drug dose3
Changes in body temperature as measured using passive sensing via an Oura ring (exploratory)
The Oura ring is a wearable device that synchronizes with a smartphone application. It records average nighttime skin temperature to track deviations from personal baseline, providing insights into readiness, health changes, and menstrual cycle trends.
Time frame
Baseline to 30 days after the second drug dose4
Changes in heart rate as measured using passive sensing via an Oura ring (exploratory)
The Oura ring is a wearable device that synchronizes with a smartphone application. It records resting heart rate and heart rate variability, primarily during sleep and select daytime sessions.
Time frame
Baseline to 30 days after the second drug doseSponsors and contacts
Click on the lead sponsor to view all of their trials.
Yale University
Lead sponsor
Michael J. Fox Foundation for Parkinson's Research
Collaborator
Source ClinicalTrials.gov