Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease
- Registration Number
- NCT04932434
- Lead Sponsor
- Joshua Woolley, MD, PhD
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 12
- Age 40 to 75
- Comfortable speaking and writing in English
- 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
- Currently experiencing depression and/or anxiety (a formal diagnosis is not necessary)
- Able to attend all in-person visits at UCSF as well as virtual visits
- Have a care partner/support person available throughout the study
- Have an established primary care provider, neurologist, or psychiatrist
- Psychotic symptoms involving loss of insight
- Significant cognitive impairment
- Regular use of medications that may have problematic interactions with psilocybin, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate (NMDAR) antagonists, antipsychotics, and stimulants
- A health condition that makes this study unsafe or unfeasible, determined by study physicians
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Psilocybin therapy Psilocybin therapy Participants will receive one or two doses of psilocybin in a monitored setting approximately two weeks apart, with preparation sessions before and integration sessions after.
- Primary Outcome Measures
Name Time Method Parkinson's Disease (PD) symptom severity Baseline to 30 days following last drug dose Measured by Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Participant-reported subjective experience Measured on each drug administration session day, following drug dose Measured by 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
Suicide Risk Baseline to 30 days following last drug dose Measured by Columbia Suicide Severity Rating Scale (C-SSRS)
Psychotic symptoms Baseline to 30 days following last drug dose Measured by Psychosis and Hallucinations Questionnaire in Parkinson's Disease (PsycH-Q)
Cognitive Safety Baseline to 30 days following last drug dose Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB)
Caregiver/support person-reported distress Baseline to 90 days following last drug dose Measured by Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q)
Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD Baseline to 3 months following last drug dose Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
Recruitment rate Baseline to 3 months following last drug dose Measured by the number of participants entering the trial multiplied by the number of months of active recruitment time
Retention rate Baseline to 3 months following last drug dose 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
Treatment Satisfaction of psilocybin therapy for depression and anxiety in people with PD Baseline to 3 months following last drug dose 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University of California, San Francisco
🇺🇸San Francisco, California, United States