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Clinical trial

Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study

ID
Name
20-32641
Description
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.
Trial arms
Trial start
2021-08-15
Estimated PCD
2023-06-13
Trial end
2023-12-31
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
Psilocybin therapy
Other names:
4-phosphoryloxy-N,N-dimethyltryptamine
Size
12
Primary endpoint
Parkinson's Disease (PD) symptom severity
Baseline to 30 days following last drug dose
Suicide Risk
Baseline to 30 days following last drug dose
Psychotic symptoms
Baseline to 30 days following last drug dose
Psychotic symptoms
Baseline to 30 days following last drug dose
Cognitive Safety
Baseline to 30 days following last drug dose
Caregiver/support person-reported distress
Baseline to 90 days following last drug dose
Participant-reported subjective experience
Measured on each drug administration session day, following drug dose
Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD
Baseline to 3 months following last drug dose
Recruitment rate
Baseline to 3 months following last drug dose
Retention rate
Baseline to 3 months following last drug dose
Treatment Satisfaction of psilocybin therapy for depression and anxiety in people with PD
Baseline to 3 months following last drug dose
Eligibility criteria
Inclusion Criteria: * Age 40 to 75 * Comfortable speaking and writing in English * 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 * 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 Exclusion Criteria: * 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single Group Assignment', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2024-05-08

1 organization

1 product

3 indications

Organization
Joshua Woolley, MD, PhD
Product
Psilocybin
Indication
Parkinson's disease
Indication
Major Depressive Disorder
Indication
Anxiety