- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04932434
Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease (PDP)
Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 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.
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD
Time Frame: Baseline to 3 months following last drug dose
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- Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
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Baseline to 3 months following last drug dose
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Recruitment rate
Time Frame: Baseline to 3 months following last drug dose
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- Measured by the number of participants entering the trial multiplied by the number of months of active recruitment time
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Baseline to 3 months following last drug dose
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Retention rate
Time Frame: Baseline to 3 months following last drug dose
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- The number of participants completing all stages of the study will be presented as a percentage of the number of total number of participants recruited
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Baseline to 3 months following last drug dose
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Treatment Satisfaction of psilocybin therapy for depression and anxiety in people with PD
Time Frame: Baseline to 3 months following last drug dose
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Measured by the treatment satisfaction questionnaire
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Baseline to 3 months following last drug dose
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Effects of psilocybin therapy on depression in people with PD (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on anxiety in people with PD (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on self-reported apathy (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Apathy Scale
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on self-reported depression (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Depression Scale
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on self-reported lower extremity function (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Lower Extremity Function Scale
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on self-reported Upper Extremity Function (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Upper Extremity Function Scale
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on self-reported Cognitive Function (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Cognitive Function Scale
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on self-reported Fatigue (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Scale
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on self-reported Concern with Death and Dying (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Concern with Death and Dying Scale
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on self-reported Social Roles and Activities (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Measured using the Quality of Life in Neurological Disorders (Neuro-QoL) Social Roles and Activities Scale
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Baseline to 3 months following last drug dose
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Effects of psilocybin therapy on self-reported Positive Affect and Well-Being (exploratory)
Time Frame: Baseline to 3 months following last drug dose
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Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Positive Affect and Well-Being Scale
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Baseline to 3 months following last drug dose
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Joshua Woolley, MD/PhD, University of California, San Francisco
- Study Director: Ellen Bradley, MD, University of California, San Francisco
Publications and helpful links
General Publications
- GBD 2016 Parkinson's Disease Collaborators. Global, regional, and national burden of Parkinson's disease, 1990-2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet Neurol. 2018 Nov;17(11):939-953. doi: 10.1016/S1474-4422(18)30295-3. Epub 2018 Oct 1. Erratum In: Lancet Neurol. 2021 Dec;20(12):e7.
- Weintraub D, Burn DJ. Parkinson's disease: the quintessential neuropsychiatric disorder. Mov Disord. 2011 May;26(6):1022-31. doi: 10.1002/mds.23664.
- Maillet A, Krack P, Lhommee E, Metereau E, Klinger H, Favre E, Le Bars D, Schmitt E, Bichon A, Pelissier P, Fraix V, Castrioto A, Sgambato-Faure V, Broussolle E, Tremblay L, Thobois S. The prominent role of serotonergic degeneration in apathy, anxiety and depression in de novo Parkinson's disease. Brain. 2016 Sep;139(Pt 9):2486-502. doi: 10.1093/brain/aww162. Epub 2016 Aug 17.
- Schapira AHV, Chaudhuri KR, Jenner P. Non-motor features of Parkinson disease. Nat Rev Neurosci. 2017 Jul;18(7):435-450. doi: 10.1038/nrn.2017.62. Epub 2017 Jun 8. Erratum In: Nat Rev Neurosci. 2017 Aug;18(8):509.
- Weintraub D, Moberg PJ, Duda JE, Katz IR, Stern MB. Effect of psychiatric and other nonmotor symptoms on disability in Parkinson's disease. J Am Geriatr Soc. 2004 May;52(5):784-8. doi: 10.1111/j.1532-5415.2004.52219.x.
- Barone P, Antonini A, Colosimo C, Marconi R, Morgante L, Avarello TP, Bottacchi E, Cannas A, Ceravolo G, Ceravolo R, Cicarelli G, Gaglio RM, Giglia RM, Iemolo F, Manfredi M, Meco G, Nicoletti A, Pederzoli M, Petrone A, Pisani A, Pontieri FE, Quatrale R, Ramat S, Scala R, Volpe G, Zappulla S, Bentivoglio AR, Stocchi F, Trianni G, Dotto PD; PRIAMO study group. The PRIAMO study: A multicenter assessment of nonmotor symptoms and their impact on quality of life in Parkinson's disease. Mov Disord. 2009 Aug 15;24(11):1641-9. doi: 10.1002/mds.22643.
- Ishihara L, Brayne C. A systematic review of depression and mental illness preceding Parkinson's disease. Acta Neurol Scand. 2006 Apr;113(4):211-20. doi: 10.1111/j.1600-0404.2006.00579.x.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Mood Disorders
- Parkinsonian Disorders
- Basal Ganglia Diseases
- Movement Disorders
- Synucleinopathies
- Neurodegenerative Diseases
- Depression
- Depressive Disorder
- Parkinson Disease
- Anxiety Disorders
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Receptor Agonists
- Serotonin Antagonists
- Hallucinogens
- Psilocybin
- N,N-Dimethyltryptamine
Other Study ID Numbers
- 20-32641
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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