Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-15

Study Completion Date

2024-12-31

Brief Summary

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The purpose of this study is to determine the safety, tolerability, and feasibility of psilocybin therapy for depression and anxiety in people with Parkinson's disease.

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Detailed Description

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This is an open-label single-arm pilot study of oral psilocybin therapy for depression and anxiety in people with Parkinson's Disease (PD). The primary goal is to examine safety, tolerability, and feasibility of the intervention in this patient population. We will enroll people ages 40 to 75 with clinically diagnosed early stage Parkinson's Disease (Hoehn and Yahr Stage 1-3 during an "off" period), who meet DSM-5 criteria for a depressive or anxious disorder and meet all other inclusion and exclusion criteria at screening. After baseline assessments, participants will complete preparation sessions designed to provide information about the psilocybin experience and to build rapport/trust with the study team. Next, participants will complete a first psilocybin administration session, receiving a low-moderate dose of 10 mg oral psilocybin in a supervised setting with safety monitoring by a physician. Participants who do not experience significant adverse events during or following the session will complete a second psilocybin administration session approximately two weeks later. During the second psilocybin administration session, participants will receive a moderate-high dose of 25 mg oral. The second session will involve the same procedures and level of monitoring as the first. Participants will subsequently complete multiple follow-up sessions designed to assess PD and psychiatric symptoms as well as to provide support as they process their psilocybin experiences. Follow-up will continue to 3 months after the second psilocybin administration session. Primary endpoints will assess safety, tolerability, and feasibility of study procedures. Exploratory efficacy endpoints will assess changes in depressive symptoms, anxious symptoms, and related measures of function.

Conditions

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Parkinson Disease Depression Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Psilocybin therapy

Participants will receive one or two doses of psilocybin in a monitored setting approximately two weeks apart, with preparation sessions before and integration sessions after.

Group Type EXPERIMENTAL

Psilocybin therapy

Intervention Type DRUG

* Psilocybin administration session 1: 10mg delivered orally with psychological support and monitoring
* Psilocybin administration session 2: 25mg delivered orally with psychological support and monitoring

Interventions

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Psilocybin therapy

* Psilocybin administration session 1: 10mg delivered orally with psychological support and monitoring
* Psilocybin administration session 2: 25mg delivered orally with psychological support and monitoring

Intervention Type DRUG

Other Intervention Names

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4-phosphoryloxy-N,N-dimethyltryptamine

Eligibility Criteria

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Inclusion Criteria

* Age 40 to 75
* Comfortable speaking and writing in English

Exclusion Criteria

* Currently experiencing depression and/or anxiety (a formal diagnosis is not necessary)
* Able to attend all in-person visits at UCSF as well as virtual visits
* Have a care partner/support person available throughout the study
* Have an established primary care provider, neurologist, or psychiatrist

* 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 (NMDAR) antagonists, antipsychotics, and stimulants
* A health condition that makes this study unsafe or unfeasible, determined by study physicians

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No