Parkinson DiseasePhase 2PDP2NCT06455293
Psilocybin Therapy for Depression in Parkinson's Disease
A Phase 2 study testing Psilocybin and Pimavanserin 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 understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease, Depression
- What is being tested?
- Psilocybin and Pimavanserin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2024to Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 40 to 80
- Comfortable speaking and writing in English
- Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an "on" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)
- Currently experiencing depressive symptoms
- Able to attend all in-person visits at UCSF as well as virtual visits
- Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating
Who cannot join
- Psychotic symptoms involving loss of insight
- Significant cognitive impairment
- Regular use of medications that may have problematic interactions with psilocybin
- A health condition that makes this study unsafe or unfeasible, determined by study physicians
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ellen Bradley, MD contact
United States1 site, 1 recruiting
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Brigette Sosa, (415) 935-3489, pdp2@ucsf.edu
Kimberly Sakai, pdp2@ucsf.edu
About this study
Official title: The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
Read the detailed description
This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. We will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an "on" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low ("microdose") to high in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments, neuroimaging, non-invasive brain stimulation, and peripheral blood draws will be used to quantify changes in depression, other non-motor and motor symptoms of PD, quality of life, and selected neural and blood-based biomarkers at multiple time points. Follow-up will continue to 3 months after the second session. Primary endpoints will evaluate efficacy, safety, and tolerability of study procedures. After posting of these trial results, this data will be combined with the data from the trial at Yale University (NCT07610369) for publication purposes.
- Conditions
- Parkinson Disease, Depression
- Being tested
- Psilocybin, Pimavanserin
- Keywords
- Parkinson Disease, Depression, Psilocybin, Psilocybin therapy, Movement disorder
- Medical subject headings
- Parkinson Disease, Depression, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsilocybinDrug
Also called 4-phosphoryloxy- N,N-dimethyltryptamine
Single dose of psilocybin ranging from low ("microdose") to high delivered orally in two separate drug administration sessions with psychological support and monitoring.
PimavanserinDrug
Participants will receive either pimavanserin or placebo during their drug administration sessions.
| Study group | Role | What they receive |
|---|---|---|
| Psilocybin Administration Session 1 | Experimental | Participants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after. Receives: Drug: Psilocybin; Drug: Pimavanserin |
| Psilocybin Administration Session 2 | Experimental | Participants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after. Receives: Drug: Psilocybin; Drug: Pimavanserin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease
Changes in depression as measured by the MADRS
Measured: Baseline to 30 days after first drug dose
Secondary outcomes (10)
Changes in depression severity
Measured by Beck Depression Inventory-2 (BDI-2) scores
Measured: 7 days after first drug dose to 90 days after second drug dose
Changes in clinician-assessed depression
Measured by the Montgomery-Asberg Depression Rating Scale (MADRS)
Measured: Baseline to 90 days after second drug dose
Changes in anxiety
Measured by the Parkinson Anxiety Scale (PAS)
Measured: Baseline to 90 days after second drug dose
Changes in PD symptom severity
Measured by the Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Measured: Baseline to 90 days after second drug dose
Changes in Quality of Life
Measured by the 36-item Short Form survey (SF-36)
Measured: Baseline to 90 days after second drug dose
Changes in cognitive performance
Measured by a multi-task assessment
Measured: Baseline to 90 days after second drug dose
Safety and tolerability of psilocybin therapy for depression in people with PD
Incidence, severity, and frequency of Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)
Measured: Baseline to 90 days after second drug dose
Changes in clinician-rated psychotic symptoms
Measured by the Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)
Measured: Baseline to 90 days after second drug dose
Subjective effects of psilocybin
Measured by the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)
Measured: Up to 30 and 60 days after Baseline
Participant-reported acceptability of study procedures
Measured by the study-specific Treatment Satisfaction Questionnaire-Participant (TSQ-P)
Measured: 30 days after second drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start19 Aug 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants will receive two doses of psilocybin ranging from low ("microdose") to high. All participants will receive three psilocybin preparation sessions, two administration sessions of a single dose of psilocybin within a therapeutic environment (6-8 hours), five integration sessions, and two follow up visits. All drugs will be orally administered during the dosing sessions. The study procedures will follow best practices for administering psilocybin in clinical trials.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
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, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455293
- Sponsor's protocol ID
- IRB#20-32641
- Acronym
- PDP2
- Status last verified
- May 2026
- First submitted
- 30 May 2024
- Last updated
- 7 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06455293
- Acronym / sponsor ID
- PDP2 / IRB#20-32641
- Conditions
- Parkinson Disease, Depression
- Keywords
- Parkinson Disease, Depression, Psilocybin, Psilocybin therapy, Movement disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Joshua Woolley, MD, PhDUniversity, hospital or other
- Study start
- 19 Aug 2024 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
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 understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.
Detailed description
This is a randomized controlled trial of oral psilocybin therapy for depression in people with Parkinson's disease (PD). The primary goal is to examine efficacy of psilocybin therapy in this patient population. We will enroll 60 people ages 40 to 80 with clinically diagnosed early to moderate stage Parkinson's disease (Hoehn and Yahr Stage 1-3 during an "on" period), who meet criteria for moderate or greater depression severity and meet all other inclusion and exclusion criteria at screening. Participants will complete two drug administration sessions where they will each receive a dose of oral psilocybin ranging from low ("microdose") to high in a medically monitored setting with psychotherapeutic support. Participants will also complete a series of psychotherapy sessions before and after each drug administration session. Clinical assessments, neuroimaging, non-invasive brain stimulation, and peripheral blood draws will be used to quantify changes in depression, other non-motor and motor symptoms of PD, quality of life, and selected neural and blood-based biomarkers at multiple time points. Follow-up will continue to 3 months after the second session. Primary endpoints will evaluate efficacy, safety, and tolerability of study procedures. After posting of these trial results, this data will be combined with the data from the trial at Yale University (NCT07610369) for publication purposes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants will receive two doses of psilocybin ranging from low ("microdose") to high. All participants will receive three psilocybin preparation sessions, two administration sessions of a single dose of psilocybin within a therapeutic environment (6-8 hours), five integration sessions, and two follow up visits. All drugs will be orally administered during the dosing sessions. The study procedures will follow best practices for administering psilocybin in clinical trials.
| Arm | Type | Receives |
|---|---|---|
| Psilocybin Administration Session 1 | Experimental | Drug: Psilocybin, Drug: PimavanserinParticipants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after. |
| Psilocybin Administration Session 2 | Experimental | Drug: Psilocybin, Drug: PimavanserinParticipants will receive one dose of psilocybin ranging from low ("microdose") to high and either pimavanserin or a placebo capsule in a medically monitored setting with preparation sessions before and integration sessions after. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 40 to 80
- Comfortable speaking and writing in English
- Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an "on" phase (time when medication/DBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)
- Currently experiencing depressive symptoms
- 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
- 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 |
|---|---|---|
| PsilocybinAlso: 4-phosphoryloxy- N,N-dimethyltryptamineSingle dose of psilocybin ranging from low ("microdose") to high delivered orally in two separate drug administration sessions with psychological support and monitoring. | Drug | Psilocybin Administration Session 1, Psilocybin Administration Session 2 |
| PimavanserinParticipants will receive either pimavanserin or placebo during their drug administration sessions. | Drug | Psilocybin Administration Session 1, Psilocybin Administration Session 2 |
Primary outcome
Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease
Time frame: Baseline to 30 days after first drug dose
Changes in depression as measured by the MADRS
10 secondary outcomes
Changes in depression severity
Time frame: 7 days after first drug dose to 90 days after second drug dose
Changes in clinician-assessed depression
Time frame: Baseline to 90 days after second drug dose
Changes in anxiety
Time frame: Baseline to 90 days after second drug dose
Changes in PD symptom severity
Time frame: Baseline to 90 days after second drug dose
Changes in Quality of Life
Time frame: Baseline to 90 days after second drug dose
Changes in cognitive performance
Time frame: Baseline to 90 days after second drug dose
Safety and tolerability of psilocybin therapy for depression in people with PD
Time frame: Baseline to 90 days after second drug dose
Changes in clinician-rated psychotic symptoms
Time frame: Baseline to 90 days after second drug dose
Subjective effects of psilocybin
Time frame: Up to 30 and 60 days after Baseline
Participant-reported acceptability of study procedures
Time frame: 30 days after second drug dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Click here to take our survey to see if you're eligibleLink provided by the sponsor.
- 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.
Ellen Bradley, MD contact
Joshua Woolley, MD,PhD principal investigator
University of California, San Francisco
Ellen Bradley, MD principal investigator
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 and Pimavanserin 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 6 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: looking for participants now, as of the sponsor's last update on 7 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brigette Sosa ((415) 935-3489, pdp2@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease (time frame: Baseline to 30 days after first drug dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Aug 2026.