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Psychedelic Therapy

Psilocybin Therapy for Depression in Parkinson's Disease (PDP2 Trial)

Phase 2
Recruiting
Led By Joshua Woolley, MD,PhD
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 80
Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an 'on' phase
Must not have
Significant cognitive impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights

Summary

"This trial aims to see if individuals with Parkinson's Disease and depression experience symptom improvement after receiving psilocybin therapy."

Who is the study for?
This trial is for English-speaking adults aged 40-80 with Parkinson's Disease (stages 1-3) and depression, who can attend visits at UCSF. They must have a doctor managing their condition but cannot join if they have psychotic symptoms, significant cognitive issues, or use certain medications like dopamine agonists or MAO inhibitors.
What is being tested?
The study aims to see if psilocybin therapy helps improve depressive symptoms in those with Parkinson's Disease. Participants will receive psilocybin treatment and their symptom changes will be monitored.
What are the potential side effects?
While not explicitly listed here, common side effects of psilocybin may include nausea, headache, dizziness, increased heart rate and blood pressure, visual alterations, mood changes, and potential psychological distress.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 40 and 80 years old.
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I have Parkinson's diagnosed by a neurologist, in early to mid-stage.
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I am currently feeling depressed.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have significant memory or thinking problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days after first drug dose to 90 days after second drug dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days after first drug dose to 90 days after second drug dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease
Secondary outcome measures
Care partner/support person reported distress
Changes in PD symptom severity
Changes in Quality of Life
+8 more
Other outcome measures
Changes in brain structure and function (exploratory)
Changes in participant reported pain (exploratory)
Changes in participant reported sleep (exploratory)
+4 more

Side effects data

From 2021 Phase 2 trial • 95 Patients • NCT02061293
9%
Nausea
7%
Pain
7%
Viral upper resp. tract infection
7%
Back pain
7%
Bronchitis
4%
Diarrhea
4%
Influenza
4%
Headache
4%
Sinus headache
4%
Depressed mood
4%
Depression
4%
Insomnia
4%
Suicidal Ideation
4%
Lower resp. tract congestion
4%
Oropharyngeal pain
4%
Alcohol withdrawal syndrome
2%
Migraine
2%
Thrombocytosis
2%
Constipation
2%
Vomiting
2%
Oedema
2%
Peripheral swelling
2%
Pyrexia
2%
Dermatitis contact
2%
Bronchitis bacterial
2%
Eye infection
2%
Fungal infection
2%
Traumatic lung injury
2%
Hyponatremia
2%
Arthralgia
2%
Musculoskeletal pain
2%
Pain in extremity
2%
Malignant melanoma
2%
Dizziness
2%
Hypoesthesia
2%
Sedation
2%
Anger
2%
Anxiety
2%
Restlessness
2%
Cough
2%
Rhinorrhea
2%
Sinus congestion
2%
Sexual abuse
2%
Endodontic procedure
2%
Mallory-Weiss Syndrom
2%
Anemia
2%
Influenza like Illness
2%
Gingivitis
2%
Arthoscopic surgery
100%
80%
60%
40%
20%
0%
Study treatment Arm
Diphenhydramine
Psilocybin

Trial Design

2Treatment groups
Experimental Treatment
Group I: Psilocybin Administration Session 2Experimental Treatment1 Intervention
Participants will receive one dose of psilocybin between 1-25mg in a monitored setting with preparation sessions before and integration sessions after.
Group II: Psilocybin Administration Session 1Experimental Treatment1 Intervention
Participants will receive one dose of psilocybin between 1-25mg in a monitored setting with preparation sessions before and integration sessions after.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psilocybin
2021
Completed Phase 2
~750

Find a Location

Who is running the clinical trial?

Joshua Woolley, MD, PhDLead Sponsor
1 Previous Clinical Trials
12 Total Patients Enrolled
Ellen Bradley, MDStudy DirectorUniversity of California, San Francisco
1 Previous Clinical Trials
12 Total Patients Enrolled
Joshua Woolley, MD,PhDPrincipal InvestigatorUniversity of California, San Francisco
1 Previous Clinical Trials
30 Total Patients Enrolled
~40 spots leftby Jun 2027
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