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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Psilocybin therapy | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psilocybin therapy | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parkinson's Disease (PD) symptom severity | Measured by Unified Parkinson's Disease Rating Scale (MDS-UPDRS) | Baseline to 30 days following last drug dose |
| Suicide Risk | Measured by Columbia Suicide Severity Rating Scale (C-SSRS) | Baseline to 30 days following last drug dose |
| Psychotic symptoms | Measured by Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD) | Baseline to 30 days following last drug dose |
| Psychotic symptoms | Measured by Psychosis and Hallucinations Questionnaire in Parkinson's Disease (PsycH-Q) | Baseline to 30 days following last drug dose |
| Cognitive Safety | Measured by Cambridge Neuropsychological Test Automated Battery (CANTAB) | Baseline to 30 days following last drug dose |
| Caregiver/support person-reported distress | Measured by Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q) | Baseline to 90 days following last drug dose |
| Participant-reported subjective experience | Measured by 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC) | Measured on each drug administration session day, following drug dose |
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| Measure | Description | Time Frame |
|---|---|---|
| Effects of psilocybin therapy on depression in people with PD (exploratory) | Measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
| Baseline to 3 months following last drug dose |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joshua Woolley, MD/PhD | University of California, San Francisco | Principal Investigator |
| Ellen Bradley, MD | University of California, San Francisco | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30287051 | Background | 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. | |
| 21626547 | Background | Weintraub D, Burn DJ. Parkinson's disease: the quintessential neuropsychiatric disorder. Mov Disord. 2011 May;26(6):1022-31. doi: 10.1002/mds.23664. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Dec 29, 2025 | Jan 16, 2026 | 14 |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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Single Group Assignment
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|
| Safety and tolerability of psilocybin therapy for depression and anxiety in people with PD | Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs) | Baseline to 3 months following last drug dose |
| Recruitment rate | Measured by the number of participants entering the trial multiplied by the number of months of active recruitment time | Baseline to 3 months following last drug dose |
| Retention rate | 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 | Baseline to 3 months following last drug dose |
| Treatment Satisfaction of psilocybin therapy for depression and anxiety in people with PD | Measured by the treatment satisfaction questionnaire
| Baseline to 3 months following last drug dose |
| Effects of psilocybin therapy on anxiety in people with PD (exploratory) |
Changes in anxiety assessed by the Hamilton Anxiety (HAM-A) Rating Scale
|
| Baseline to 3 months following last drug dose |
| Cognitive Flexibility | Measured by the Probabilistic Reversal Learning (PRL) task | Baseline to 30 days following last drug dose |
| Cognitive Flexibility | Measured by the Cognitive Control and Flexibility Questionnaire | Baseline to 30 days following last drug dose |
| Transformational Experience | Measured by the study-specific Transformational Experiences Questionnaire (TEQ) | Baseline to 90 days following last drug dose |
| Self-report changes to wellbeing | Measured by the Quality of Life in Neurological Disorders
| Baseline to 90 days following last drug dose |
| Self-report changes to wellbeing | Measured using the Patient-Reported Outcomes Measurement Information Systems
| Baseline to 90 days following last drug dose |
| 27538418 | Background | 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. |
| 28592904 | Background | 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. |
| 15086662 | Background | 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. |
| 19514014 | Background | 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. |
| 16542159 | Background | 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. |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |