The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy for depression and anxiety in people with Parkinson's disease.
This is an open-label single-arm pilot study of oral psilocybin therapy for depression and anxiety in people with Parkinson's Disease (PD). The primary goal is to examine safety, tolerability, and feasibility of the intervention in this patient population. We will enroll people ages 40 to 75 with clinically diagnosed early stage Parkinson's Disease (Hoehn and Yahr Stage 1-3 during an "off" period), who meet DSM-5 criteria for a depressive or anxious disorder and meet all other inclusion and exclusion criteria at screening. After baseline assessments, participants will complete preparation sessions designed to provide information about the psilocybin experience and to build rapport/trust with the study team. Next, participants will complete a first psilocybin administration session, receiving a low-moderate dose of 10 mg oral psilocybin in a supervised setting with safety monitoring by a physician. Participants who do not experience significant adverse events during or following the session will complete a second psilocybin administration session approximately two weeks later. During the second psilocybin administration session, participants will receive a moderate-high dose of 25 mg oral. The second session will involve the same procedures and level of monitoring as the first. Participants will subsequently complete multiple follow-up sessions designed to assess PD and psychiatric symptoms as well as to provide support as they process their psilocybin experiences. Follow-up will continue to 3 months after the second psilocybin administration session. Primary endpoints will assess safety, tolerability, and feasibility of study procedures. Exploratory efficacy endpoints will assess changes in depressive symptoms, anxious symptoms, and related measures of function.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
* Psilocybin administration session 1: 10mg delivered orally with psychological support and monitoring * Psilocybin administration session 2: 25mg delivered orally with psychological support and monitoring
University of California, San Francisco
San Francisco, California, United States
Parkinson's Disease (PD) symptom severity
Measured by Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline to 30 days following last drug dose
Suicide Risk
Measured by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Baseline to 30 days following last drug dose
Psychotic symptoms
Measured by Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)
Time frame: Baseline to 30 days following last drug dose
Psychotic symptoms
Measured by Psychosis and Hallucinations Questionnaire in Parkinson's Disease (PsycH-Q)
Time frame: Baseline to 30 days following last drug dose
Cognitive Safety
Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB)
Time frame: Baseline to 30 days following last drug dose
Caregiver/support person-reported distress
Measured by Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q)
Time frame: Baseline to 90 days following last drug dose
Participant-reported subjective experience
Measured by 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
Time frame: Measured on each drug administration session day, following drug dose
Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD
Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
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Time frame: Baseline to 3 months following last drug dose
Recruitment rate
Measured by the number of participants entering the trial multiplied by the number of months of active recruitment time
Time frame: Baseline to 3 months following last drug dose
Retention rate
The number of participants completing all stages of the study will be presented as a percentage of the number of total number of participants recruited
Time frame: Baseline to 3 months following last drug dose
Treatment Satisfaction of psilocybin therapy for depression and anxiety in people with PD
Measured by the treatment satisfaction questionnaire * 5-item scale, plus three free response questions * items are ranked from 1-to-7, with higher scores representing better treatment satisfaction
Time frame: Baseline to 3 months following last drug dose