Psilocybin Therapy for Depression in Parkinson's Disease

Depression Clinical Trial

— PDP2  

Official title:

The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06455293
• Other study ID #: IRB#20-32641
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Parkinson Disease

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