Parkinson DiseasePhase 2PDP1NCT04932434
Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease
A Phase 2 study testing Psilocybin therapy in people with Parkinson Disease and Depression, run by Joshua Woolley, MD, PhD at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Parkinson Disease, Depression, Anxiety
- What is being tested?
- Psilocybin therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Aug 2021to 31 Dec 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study
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.
Read the detailed description
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.
- Conditions
- Parkinson Disease, Depression, Anxiety
- Being tested
- Psilocybin therapy
- Keywords
- Parkinson Disease, Depression, Anxiety, Psilocybin, Psilocybin therapy, Movement disorder
- Medical subject headings
- Parkinson Disease, Depression, Anxiety Disorders, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psilocybin therapyDrug
Also called 4-phosphoryloxy-N,N-dimethyltryptamine
- Psilocybin administration session 1: 10mg delivered orally with psychological support and monitoring
- Psilocybin administration session 2: 25mg delivered orally with psychological support and monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Psilocybin therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Movement Disorder Society-sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
This clinician-administered assessment measures the severity of Parkinson's disease symptoms.The MDS-UPDRS has four subscales:
- I: Non-motor Experiences of Daily Living -- 13 items
- II: Motor Experiences of Daily Living -- 13 items
- III: Motor Examination -- 33 items
- IV: Motor Complications -- 6 items
All 65 items across subscales are rated on a 5-point scale (0-4). Total scores were calculated by summing the scores across all 65 items.
Higher scores indicate more severe Parkinson's disease symptoms.
Measured: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Columbia Suicide Severity Rating Scale (C-SSRS)
The C-SSRS measures suicidal ideation (SI) in 6 categories, each scored on a binary scale of Yes or No (coded 1 or 0, respectively): 1) Wish to be Dead; 2) Non-specific Active Suicidal Thoughts; 3) Active SI with Any Methods (Not Plan) without Intent to Act; 4) Active SI with Some Intent to Act, without Specific Plan; 5) Active SI with Specific Plan and Intent; 6) Preparatory Acts or Behavior.
Total scores are calculated as the sum of the 6 items ratings; the possible range of total scores is from 0 to 6. Higher total scores indicate more severe SI.
Measured: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)
The eSAPS-PD measures the severity of positive psychotic symptoms in individuals with Parkinson's disease.
Total scores are calculated as the sum of 11 items, each rated on a scale from 0 - 5: Minor Hallucinations, Gustatory Hallucinations, Olfactory Hallucinations, Auditory Hallucinations, Somatic or Tactile Hallucinations, Visual Hallucinations, Persecutory Delusions, Delusions of Jealousy, Delusions of Reference, Capgras Syndrome, and Other Delusions.
The range of possible total scores is 0 to 55. Higher total scores indicate more severe psychotic symptoms.
Measured: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Psychosis and Hallucinations in Parkinson's Disease Questionnaire (PsycH-Q)
This self-report questionnaire measures psychotic symptoms in individuals with Parkinson's disease. The questionnaire assesses the frequency and severity of 20 symptom. The frequency of each item is rated from 0 to 4, and the severity of each item is rated from 1 to 4. Scores for each item are determined by multiplying the frequency rating and severity rating. Total scores are then calculated by summing the scores on all 20 items. Possible total scores range from 0 to 320. Higher total scores indicate more severe and more frequent psychotic symptoms.
Measured: On day of first drug dose (which takes place 2-4 weeks after enrollment); On day of, and 11, 18, and 25 days following second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q)
This self-report measure is administered to caregivers of participants with Parkinson's disease. Respondents are asked to rate the severity of the symptoms of the individual in their care, as well as the degree of distress this causes them personally (as the caregiver). Twelve symptoms are assessed for both severity and distress, rated on scales from 1 to 3 and 0 to 5, respectively. Total scores on the severity and distress subscales are calculated by summing the respective ratings across the twelve items. Possible total scores range from 12 to 36 on the severity subscale, and from 0 to 60 on the distress subscale.
Measured: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7, 30, and 90 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
11-Dimensional Altered States of Consciousness Rating Scale (11D-ASC)
This 94-item, self-report questionnaire measures alterations in perception and cognition following administration of psilocybin. Each item is rated on a scale from 0 to 100. 11 subscales are calculated to measure alterations across different dimensions of perception and cognition, with a composite score consisting of the average score across the 11 subscales. Average composite scores have been reported here.
Measured: Measured on each drug administration session day, following drug dose
Incidence of Adverse Events
The incidence of Adverse Events are reported here by the amount of, and timing relative to, the study drug dose as a measure of the safety and tolerability of psilocybin therapy for depression and anxiety in individuals with Parkinson's disease.
Measured: 0-24 hours, 1-7 days, 8-14 days, 15-30 days, and 31-90 days after drug administration
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 enrolled in the study.
Measured: 90 days following last drug dose
Treatment Satisfaction Questionnaire (TSQ)
The Treatment Satisfaction Questionnaire (TSQ) was developed in house to measure participants' overall satisfaction with the study treatment. The measure consists of 5 items rated on a scale from 1 to 7 and three free-response questions (free response items not reported here). Reported are average scores on each of the five items; higher scores represent stronger agreement with the sentiment expressed.
Measured: 30 days following last drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2021
- Study start15 Aug 2021
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua Woolley, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Joshua Woolley, MD, PhD, University of California, San Francisco
- Investigators
- Joshua Woolley, MD/PhD, Principal investigator, University of California, San FranciscoEllen Bradley, MD, Study director, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04932434
- Sponsor's protocol ID
- 20-32641
- Acronym
- PDP1
- Status last verified
- Aug 2026
- First submitted
- 5 May 2021
- Last updated
- 3 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 30287051Weintraub D, Burn DJ. Parkinson's disease: the quintessential neuropsychiatric disorder. Mov Disord. 2011 May;26(6):1022-31. doi: 10.1002/mds.23664.
PubMed 21626547Maillet 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.
PubMed 27538418Schapira 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.
PubMed 28592904Weintraub 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.
PubMed 15086662Barone 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.
PubMed 19514014Ishihara 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.
PubMed 16542159
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psilocybin Therapy for Depression and Anxiety in Parkinson's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT04932434
- Acronym / sponsor ID
- PDP1 / 20-32641
- Conditions
- Parkinson Disease, Depression, Anxiety
- Keywords
- Parkinson Disease, Depression, Anxiety, Psilocybin, Psilocybin therapy, Movement disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Joshua Woolley, MD, PhDUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 21 Jun 2021 (actual)
- Results
- Posted 3 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Psilocybin therapy | Experimental | Drug: Psilocybin therapyParticipants will receive one or two doses of psilocybin in a monitored setting approximately two weeks apart, with preparation sessions before and integration sessions after. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psilocybin therapyAlso: 4-phosphoryloxy-N,N-dimethyltryptamine* Psilocybin administration session 1: 10mg delivered orally with psychological support and monitoring * Psilocybin administration session 2: 25mg delivered orally with psychological support and monitoring | Drug | Psilocybin therapy |
Primary outcome
Movement Disorder Society-sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
This clinician-administered assessment measures the severity of Parkinson's disease symptoms.The MDS-UPDRS has four subscales: * I: Non-motor Experiences of Daily Living -- 13 items * II: Motor Experiences of Daily Living -- 13 items * III: Motor Examination -- 33 items * IV: Motor Complications -- 6 items All 65 items across subscales are rated on a 5-point scale (0-4). Total scores were calculated by summing the scores across all 65 items. Higher scores indicate more severe Parkinson's disease symptoms.
Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
The C-SSRS measures suicidal ideation (SI) in 6 categories, each scored on a binary scale of Yes or No (coded 1 or 0, respectively): 1) Wish to be Dead; 2) Non-specific Active Suicidal Thoughts; 3) Active SI with Any Methods (Not Plan) without Intent to Act; 4) Active SI with Some Intent to Act, without Specific Plan; 5) Active SI with Specific Plan and Intent; 6) Preparatory Acts or Behavior. Total scores are calculated as the sum of the 6 items ratings; the possible range of total scores is from 0 to 6. Higher total scores indicate more severe SI.
Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)
Time frame: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
The eSAPS-PD measures the severity of positive psychotic symptoms in individuals with Parkinson's disease. Total scores are calculated as the sum of 11 items, each rated on a scale from 0 - 5: Minor Hallucinations, Gustatory Hallucinations, Olfactory Hallucinations, Auditory Hallucinations, Somatic or Tactile Hallucinations, Visual Hallucinations, Persecutory Delusions, Delusions of Jealousy, Delusions of Reference, Capgras Syndrome, and Other Delusions. The range of possible total scores is 0 to 55. Higher total scores indicate more severe psychotic symptoms.
Psychosis and Hallucinations in Parkinson's Disease Questionnaire (PsycH-Q)
Time frame: On day of first drug dose (which takes place 2-4 weeks after enrollment); On day of, and 11, 18, and 25 days following second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
This self-report questionnaire measures psychotic symptoms in individuals with Parkinson's disease. The questionnaire assesses the frequency and severity of 20 symptom. The frequency of each item is rated from 0 to 4, and the severity of each item is rated from 1 to 4. Scores for each item are determined by multiplying the frequency rating and severity rating. Total scores are then calculated by summing the scores on all 20 items. Possible total scores range from 0 to 320. Higher total scores indicate more severe and more frequent psychotic symptoms.
Neuropsychiatric Inventory Caregiver Distress Questionnaire (NPI-Q)
Time frame: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7, 30, and 90 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)
This self-report measure is administered to caregivers of participants with Parkinson's disease. Respondents are asked to rate the severity of the symptoms of the individual in their care, as well as the degree of distress this causes them personally (as the caregiver). Twelve symptoms are assessed for both severity and distress, rated on scales from 1 to 3 and 0 to 5, respectively. Total scores on the severity and distress subscales are calculated by summing the respective ratings across the twelve items. Possible total scores range from 12 to 36 on the severity subscale, and from 0 to 60 on the distress subscale.
11-Dimensional Altered States of Consciousness Rating Scale (11D-ASC)
Time frame: Measured on each drug administration session day, following drug dose
This 94-item, self-report questionnaire measures alterations in perception and cognition following administration of psilocybin. Each item is rated on a scale from 0 to 100. 11 subscales are calculated to measure alterations across different dimensions of perception and cognition, with a composite score consisting of the average score across the 11 subscales. Average composite scores have been reported here.
Incidence of Adverse Events
Time frame: 0-24 hours, 1-7 days, 8-14 days, 15-30 days, and 31-90 days after drug administration
The incidence of Adverse Events are reported here by the amount of, and timing relative to, the study drug dose as a measure of the safety and tolerability of psilocybin therapy for depression and anxiety in individuals with Parkinson's disease.
Retention Rate
Time frame: 90 days following last drug dose
The number of participants completing all stages of the study will be presented as a percentage of the number of total number of participants enrolled in the study.
Treatment Satisfaction Questionnaire (TSQ)
Time frame: 30 days following last drug dose
The Treatment Satisfaction Questionnaire (TSQ) was developed in house to measure participants' overall satisfaction with the study treatment. The measure consists of 5 items rated on a scale from 1 to 7 and three free-response questions (free response items not reported here). Reported are average scores on each of the five items; higher scores represent stronger agreement with the sentiment expressed.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30287051GBD 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.
- Background: PubMed 21626547Weintraub D, Burn DJ. Parkinson's disease: the quintessential neuropsychiatric disorder. Mov Disord. 2011 May;26(6):1022-31. doi: 10.1002/mds.23664.
- Background: PubMed 27538418Maillet 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.
- Background: PubMed 28592904Schapira 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.
- Background: PubMed 15086662Weintraub 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.
- Background: PubMed 19514014Barone 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.
- Background: PubMed 16542159Ishihara 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joshua Woolley, MD/PhD principal investigator
University of California, San Francisco
Ellen Bradley, MD study director
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Psilocybin therapy in people with Parkinson Disease and Depression, run by Joshua Woolley, MD, PhD at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society-sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS) (time frame: 7 days after first drug dose (which takes place 2-4 weeks after enrollment); 7 and 30 days after second drug dose (which takes place 2 weeks after first drug dose, i.e., 4-6 weeks after enrollment)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04932434, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.