Psilocybin Therapy for Depression in Parkinson's Disease

NCT06455293 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: IRB#20-32641
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease; Depression

Keywords

Parkinson Disease; Depression; Psilocybin; Psilocybin therapy; Movement disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• Changes in depression severity

  7 days after first drug dose to 90 days after second drug dose

• Changes in clinician-assessed depression

  Baseline to 90 days after second drug dose

• Changes in anxiety

  Baseline to 90 days after second drug dose

• Changes in PD symptom severity

  Baseline to 90 days after second drug dose

• Changes in Quality of Life

  Baseline to 90 days after second drug dose

Other Outcomes (7)

• Changes in peripheral inflammatory markers (exploratory)

  Baseline to 90 days after second drug dose

• Changes in brain structure and function (exploratory)

  Baseline to 90 days after second drug dose

• Changes in participant reported pain (exploratory)

  Baseline to 90 days after second drug dose

Study Arms (2)

Psilocybin Administration Session 1

EXPERIMENTAL

Participants will receive one dose of psilocybin ranging from low ("microdose") to high in a monitored setting with preparation sessions before and integration sessions after.

Drug: Psilocybin

Psilocybin Administration Session 2

EXPERIMENTAL

Participants will receive one dose of psilocybin ranging from low ("microdose") to high in a monitored setting with preparation sessions before and integration sessions after.

Drug: Psilocybin

Interventions

Psilocybin DRUG

Single dose of psilocybin ranging from low ("microdose") to high delivered orally with psychological support and monitoring

Also known as: 4-phosphoryloxy- N,N-dimethyltryptamine

Psilocybin Administration Session 1; Psilocybin Administration Session 2

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Psychotic symptoms involving loss of insight
• Significant cognitive impairment
• Regular use of medications that may have problematic interactions with psilocybin
• A health condition that makes this study unsafe or unfeasible, determined by study physicians

Sponsors & Collaborators

• Joshua Woolley, MD, PhD: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Depression; Movement Disorders

Interventions

Psilocybin

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Tryptamines; Indolizidines; Indolizines

Study Officials

• Joshua Woolley, MD,PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Ellen Bradley, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brigette Sosa

CONTACT

(415) 935-3489; pdp2@ucsf.edu

Ellen Bradley, MD

CONTACT

ellen.bradley@ucsf.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) This trial is testing various doses of psilocybin. Participants, study staff and clinical assessors will be blinded to individual treatment conditions until study close-out. The clinician administered instruments will be administered by different clinical study staff than the facilitators who provide the preparation, psilocybin therapy, and integration sessions.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: All participants will receive two doses of psilocybin ranging from low ("microdose") to high. All participants will receive three psilocybin preparation sessions, two administration sessions of a single dose of psilocybin within a therapeutic environment (6-8 hours), five integration sessions, and two follow up visits. All drugs will be orally administered during the dosing sessions. The study procedures will follow best practices for administering psilocybin in clinical trials.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 12, 2024
• Study Start: August 19, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: May 13, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)