NCT Number: NCT06455293
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
Interested in participating?
Request Info40 year–80 year
All sexes
Interventional
Phase 2
San Francisco, California, 94143, United States
Location status: Recruiting
Brigette Sosa
CONTACT
Ellen Bradley, MD
SUB_INVESTIGATOR
Joshua Woolley, MD,PhD
PRINCIPAL_INVESTIGATOR
Kimberly Sakai
CONTACT
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 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, 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Single dose of psilocybin ranging from low ("microdose") to high delivered orally in two separate drug administration sessions with psychological support and monitoring.
Other names: 4-phosphoryloxy- N,N-dimethyltryptamine
Participants will receive either pimavanserin or placebo during their drug administration sessions.
Time frame: Baseline to 30 days after first drug dose
Changes in depression as measured by the MADRS
Time frame: 7 days after first drug dose to 90 days after second drug dose
Measured by Beck Depression Inventory-2 (BDI-2) scores
Time frame: Baseline to 90 days after second drug dose
Measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
Time frame: Baseline to 90 days after second drug dose
Measured by the Parkinson Anxiety Scale (PAS)
Time frame: Baseline to 90 days after second drug dose
Measured by the Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Baseline to 90 days after second drug dose
Measured by the 36-item Short Form survey (SF-36)
Time frame: Baseline to 90 days after second drug dose
Measured by a multi-task assessment
Time frame: Baseline to 90 days after second drug dose
Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
Time frame: Baseline to 90 days after second drug dose
Measured by the Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)
Time frame: Up to 30 and 60 days after Baseline
Measured by the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
Time frame: 30 days after second drug dose
Measured by the study-specific Treatment Satisfaction Questionnaire-Participant (TSQ-P)
Time frame: Baseline to 90 days after second drug dose
Measured by blood-based analysis
Time frame: Baseline to 30 days after first drug dose
Measured by Positron Emission Tomography (PET) imaging, Magnetic Resonance Imaging (MRI) and Transcranial Magnetic Stimulation (TMS)
Time frame: Baseline to 90 days after second drug dose
Measured by the Parkinson's Disease Sleep Scale-2 (PDSS-2)
Time frame: Baseline to 30 days after first drug dose
Measured by using passive sensing via a wearable device
Time frame: Baseline
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.
Time frame: Up to 30 and 60 days after Baseline
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.
Contact information is provided by the study sponsor or research team.
Joshua Woolley, MD, PhD
Other
The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
Acronym: PDP2
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04932434
Anxiety, Anxiety Disorders
San Francisco, California, United States
View Trial DetailsNCT04784494
Basal Ganglia Diseases, Behavior
Vancouver, British Columbia, Canada
View Trial DetailsNCT05568498
Basal Ganglia Diseases, Behavior
Vancouver, British Columbia, Canada
View Trial DetailsNCT03217110
Autism Spectrum Disorder, Basal Ganglia Diseases
Iowa City, Iowa, United States
View Trial Details