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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06455293
Other study ID # IRB#20-32641
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date July 2024
Est. completion date June 2028

Study information

Verified date June 2024
Source University of California, San Francisco
Contact Brigette Sosa
Phone 415-881-8273
Email pdp2@ucsf.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 somewhere between 1-25 mg of oral psilocybin 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 60
Est. completion date June 2028
Est. primary completion date June 2027
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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, including but not limited to dopamine agonists, MAO inhibitors, N-methyl-D-aspartate tricyclic antidepressants, antipsychotics, and stimulants - A health condition that makes this study unsafe or unfeasible, determined by study physicians

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Psilocybin
Single dose of psilocybin between 1-25mg delivered orally with psychological support and monitoring

Locations

Country Name City State
United States University of California, San Francisco San Francisco California

Sponsors (1)

Lead Sponsor Collaborator
Joshua Woolley, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in peripheral inflammatory markers (exploratory) Measured by blood-based analysis Baseline to 90 days after second drug dose
Other Changes in brain structure and function (exploratory) Measured by Magnetic Resonance Imaging (MRI) and Transcranial Magnetic Stimulation (TMS) Baseline to 90 days after second drug dose
Other Changes in participant reported pain (exploratory) Measured by the King's Parkinson's Disease Pain Scale (KPPS) Baseline to 90 days after second drug dose
Other Changes in participant reported sleep (exploratory) Measured by the Parkinson's Disease Sleep Scale-2 (PDSS-2) Baseline to 90 days after second drug dose
Other Changes in sleep parameters, physical activity, body temperature, and heart rate (exploratory) Measured by using passive sensing via a wearable device Baseline to 30 days after first drug dose
Other Evaluation of treatment expectations (exploratory) Measured by the Treatment Expectancy questionnaire consisting of 6 questions from the Stanford Expectations of Treatment Scale. Rating point scale is from 1 (Strongly disagree) to 7 (Strongly agree). Higher scores represent greater expectations of treatment benefit. Baseline
Other Evaluation of masking procedures (exploratory) Measured by the study-specific Masking Questionnaire which includes items to assess perceived treatment assignment. Using a 7-point scale, higher scores represent greater certainty. Up to 30 and 60 days after Baseline
Primary Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease Changes in depression as measured by the Beck Depression Inventory-2 (BDI-2) Baseline to 30 days after first drug dose
Secondary Changes in depression severity Measured by Beck Depression Inventory-2 (BDI-2) scores 7 days after first drug dose to 90 days after second drug dose
Secondary Changes in clinician-assessed depression Measured by the Montgomery-Asberg Depression Rating Scale (MADRS) Baseline to 90 days after second drug dose
Secondary Changes in anxiety Measured by the Parkinson Anxiety Scale (PAS) Baseline to 90 days after second drug dose
Secondary Changes in PD symptom severity Measured by the Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Baseline to 90 days after second drug dose
Secondary Changes in Quality of Life Measured by the 36-item Short Form survey (SF-36) Baseline to 90 days after second drug dose
Secondary Changes in cognitive performance Measured by a multi-task assessment Baseline to 90 days after second drug dose
Secondary Safety and tolerability of psilocybin therapy for depression in people with PD Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs) Baseline to 90 days after second drug dose
Secondary Changes in clinician-rated psychotic symptoms Measured by the Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD) Baseline to 90 days after second drug dose
Secondary Subjective effects of psilocybin Measured by the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) Up to 30 and 60 days after Baseline
Secondary Participant-reported acceptability of study procedures Measured by the study-specific Treatment Satisfaction Questionnaire-Participant (TSQ-P) 30 days after second drug dose
Secondary Care partner/support person reported distress Measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q) Baseline to 90 days after second drug dose
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