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Psychedelic
Psilocybin therapy for Anxiety (PDP Trial)
Phase 2
Waitlist Available
Research Sponsored by Joshua Woolley, MD/PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 40 to 75
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 3 months following last drug dose
Awards & highlights
PDP Trial Summary
This trial will test whether psilocybin is safe and tolerable for people with Parkinson's disease, and whether it can help relieve their depression and anxiety.
Who is the study for?
This trial is for English-speaking adults aged 40-75 with early-stage Parkinson's Disease (stages 1-3) who are experiencing depression or anxiety. Participants must be able to attend visits at UCSF, have a support person, and an established healthcare provider. Those with severe health conditions, cognitive impairments, psychotic symptoms, or on certain medications like dopamine agonists and MAO inhibitors cannot join.Check my eligibility
What is being tested?
The study is examining the safety and effectiveness of psilocybin therapy as a treatment for depression and anxiety in individuals with Parkinson's disease. It aims to understand if this therapy can be tolerated well by patients and how feasible it is as a treatment option.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include temporary changes in perception, mood swings, dizziness, nausea or headaches during the immediate period following psilocybin administration.
PDP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 75 years old.
PDP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline to 3 months following last drug dose
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 3 months following last drug dose
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Recruitment rate
Retention rate
Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD
+1 moreSecondary outcome measures
Effects of psilocybin therapy on anxiety in people with PD (exploratory)
Effects of psilocybin therapy on depression in people with PD (exploratory)
Effects of psilocybin therapy on self-reported Cognitive Function (exploratory)
+8 morePDP Trial Design
1Treatment groups
Experimental Treatment
Group I: Psilocybin therapyExperimental Treatment1 Intervention
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.
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Who is running the clinical trial?
Joshua Woolley, MD/PhDLead Sponsor
1 Previous Clinical Trials
30 Total Patients Enrolled
Ellen Bradley, MDStudy DirectorUniversity of California, San Francisco
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can go to UCSF for visits and also do virtual ones.I am currently feeling depressed or anxious.I have early Parkinson's (stage 1-3) with depression or anxiety.I have early stage Parkinson's with depression or anxiety.I am between 40 and 75 years old.I have early Parkinson's (stage 1-3) with depression or anxiety.I am not taking medication that interacts badly with psilocybin.I have significant difficulties with my memory or thinking.
Research Study Groups:
This trial has the following groups:- Group 1: Psilocybin therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Anxiety Patient Testimony for trial: Trial Name: NCT04932434 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Colorado
Texas
Other
California
How old are they?
18 - 65
65+
What site did they apply to?
University of California, San Francisco
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0
3+
Why did patients apply to this trial?
anxiety is a major component of my parkinson's and I have. When my anxiety is under control my symptoms are almost non-existent.
PatientReceived no prior treatments
I've tried several anti-depressants but nothing worked for longer than 3-4 weeks.
PatientReceived 1 prior treatment
I believe that all of my medical records point to me having a early onset of a movement disorder syndrome.
PatientReceived 2+ prior treatments
As I face the challenges of aging, I want more stable moods, a more spiritual orientation and self-awareness.
PatientReceived 2+ prior treatments
What questions have other patients asked about this trial?
would we be able to do a zoom screening? How many visits, of what length, to the research site are required?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Email
Most responsive sites:
- University of California, San Francisco: < 48 hours
Average response time
- < 2 Days
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