The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
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. Investigators will enroll participants 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 will be used to quantify changes in depression as well as other relevant outcomes (non-motor and motor symptoms of PD, cognitive performance, quality of life). Follow-up will continue to 3 months after the second session. 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 UCSF (NCT06455293) for publication purposes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
Single dose of psilocybin ranging from low ("microdose") to high delivered orally with psychological support and monitoring
Single dose of psilocybin ranging from low ("microdose") to high delivered orally with psychological support and monitoring
Yale University
New Haven, Connecticut, United States
RECRUITINGChange 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 dose
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 dose
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 dose
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 Baseline
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 dose
Participant -reported acceptability of study procedures as measured by the study-specific Treatment Satisfaction Questionnaire-Participant (TSQ-P)
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TSQ-P is a patient-reported 7-point scale used to measure patients' satisfaction with their medication. Scores range from 0 to 7, where higher scores indicate greater satisfaction.
Time frame: 30 days after second drug dose
Changes in depression severity as measured by Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS is a 10-item clinician-administered scale used to measure the severity of depression symptoms. Overall score ranges from 0 to 60, where higher scores indicate more severe depression.
Time frame: Baseline to 90 days after second drug dose
Proportion of participants with a response (defined as a >/=50% decrease in MADRS total score) as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
MADRS is a 10-item clinician-administered scale used to measure the severity of depression symptoms. Overall score ranges from 0 to 60, where higher scores indicate more severe depression.
Time frame: 7 days after first drug dose and up to 90 days after second drug dose
Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II)
BDI-II is a 21-item patient-reported questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression.
Time frame: Baseline up to 90 days after second drug dose
Changes in anxiety as measured by the Parkinson Anxiety Scale (PAS)
PAS is a 12-item, PD-specific scale used to assess anxiety in adults with Parkinson's disease. Total scores range from 0 to 50 with higher scores indicating more severe anxiety.
Time frame: Baseline to 90 days after second drug dose
Changes in PD symptom severity as measured by the Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
MDS-UPDRS is a 50-item scale used for assessing both motor and non-motor aspects of Parkinson's disease. Total scores range from 0 to 176 with higher scores indicating more severe disease.
Time frame: Baseline to 90 days after second drug dose
Changes in cognitive performance as measured by multi-task assessments to include Probabilistic Reversal Task, Category Switch Task, Simon Task, Delay Discounting Task, California Verbal Learning Test-II, Digit span forward and backward
Probabilistic Reversal Task measures flexible learning, Category Switch Task measures mental set shifting, Simon Task measures selective attention, Delay Discounting Task measures impulse control/waiting for rewards, California Verbal Learning Test (CVLT-II) measures short- and long-term memory, Digit Span Forward and Backward measures working memory.
Time frame: Baseline to 90 days after second drug dose
Changes in Quality of Life as measured by the 36-item Short Form survey (SF-36)
SF-36 is a patient-reported 36-item scale used to measure health-related quality of life. Total scores range from 0 to 100 with higher scores indicating better health.
Time frame: Baseline to 90 days after second drug dose