Psilocybin Therapy for Depression in Parkinson's Disease

Phase 2RecruitingNCT06455293

Joshua Woolley, MD, PhD60 enrolled

Overview

The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson Disease Depression

Interventions

PsilocybinDRUG

Single dose of psilocybin ranging from low ("microdose") to high delivered orally in two separate drug administration sessions with psychological support and monitoring.

PimavanserinDRUG

Participants will receive either pimavanserin or placebo during their drug administration sessions.

Eligibility

Sex: ALLMin age: 40 YearsMax age: 80 Years

Medical Language ↔ Plain English

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 * A health condition that makes this study unsafe or unfeasible, determined by study physicians

Locations (1)

University of California, San Francisco

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease

Changes in depression as measured by the MADRS

Time frame: Baseline to 30 days after first drug dose

Secondary Outcomes

Changes in depression severity

Measured by Beck Depression Inventory-2 (BDI-2) scores

Time frame: 7 days after first drug dose to 90 days after second drug dose

Changes in clinician-assessed depression

Measured by the Montgomery-Asberg Depression Rating Scale (MADRS)