[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06455293":3,"trial-entities:NCT06455293":141,"trial-summary:NCT06455293":144},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":45,"secondary_outcomes":50,"sex":85,"minimum_age":86,"maximum_age":87,"healthy_volunteers":88,"eligibility_criteria":89,"std_ages":103,"locations":106,"central_contacts":130,"overall_officials":133,"references":136,"see_also_links":137},"NCT06455293","IRB#20-32641","Psilocybin Therapy for Depression in Parkinson's Disease","The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease","RECRUITING","2028-06","2026-05","2026-08-07","2024-08-19","Joshua Woolley, MD, PhD","OTHER",true,"The purpose of this study is to understand whether people with Parkinson's Disease and depression have improvement in their symptoms after psilocybin therapy.","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.",[19,20],"Parkinson Disease","Depression",[19,20,22,23,24],"Psilocybin","Psilocybin therapy","Movement disorder","INTERVENTIONAL","TREATMENT",[28],"PHASE2",{"count":30,"type":31},60,"ESTIMATED",[33,41],{"type":34,"name":22,"description":35,"armGroupLabels":36,"otherNames":39},"DRUG","Single dose of psilocybin ranging from low (\"microdose\") to high delivered orally in two separate drug administration sessions with psychological support and monitoring.",[37,38],"Psilocybin Administration Session 1","Psilocybin Administration Session 2",[40],"4-phosphoryloxy- N,N-dimethyltryptamine",{"type":34,"name":42,"description":43,"armGroupLabels":44},"Pimavanserin","Participants will receive either pimavanserin or placebo during their drug administration sessions.",[37,38],[46],{"measure":47,"description":48,"timeFrame":49},"Evaluate the efficacy of psilocybin for improving depression in people living with Parkinson's disease","Changes in depression as measured by the MADRS","Baseline to 30 days after first drug dose",[51,55,59,62,65,68,71,74,77,81],{"measure":52,"description":53,"timeFrame":54},"Changes in depression severity","Measured by Beck Depression Inventory-2 (BDI-2) scores","7 days after first drug dose to 90 days after second drug dose",{"measure":56,"description":57,"timeFrame":58},"Changes in clinician-assessed depression","Measured by the Montgomery-Asberg Depression Rating Scale (MADRS)","Baseline to 90 days after second drug dose",{"measure":60,"description":61,"timeFrame":58},"Changes in anxiety","Measured by the Parkinson Anxiety Scale (PAS)",{"measure":63,"description":64,"timeFrame":58},"Changes in PD symptom severity","Measured by the Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)",{"measure":66,"description":67,"timeFrame":58},"Changes in Quality of Life","Measured by the 36-item Short Form survey (SF-36)",{"measure":69,"description":70,"timeFrame":58},"Changes in cognitive performance","Measured by a multi-task assessment",{"measure":72,"description":73,"timeFrame":58},"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)",{"measure":75,"description":76,"timeFrame":58},"Changes in clinician-rated psychotic symptoms","Measured by the Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)",{"measure":78,"description":79,"timeFrame":80},"Subjective effects of psilocybin","Measured by the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)","Up to 30 and 60 days after Baseline",{"measure":82,"description":83,"timeFrame":84},"Participant-reported acceptability of study procedures","Measured by the study-specific Treatment Satisfaction Questionnaire-Participant (TSQ-P)","30 days after second drug dose","ALL","40 Years","80 Years",false,{"inclusion":90,"exclusion":97,"raw_text":102},[91,92,93,94,95,96],"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\u002FDBS 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",[98,99,100,101],"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","Inclusion Criteria:\n\n* Age 40 to 80\n* Comfortable speaking and writing in English\n* Have neurologist-diagnosed idiopathic Parkinson's disease (PD), Hoehn and Yahr stages 1 to 3 during an \"on\" phase (time when medication\u002FDBS for parkinsonian motor feature, including bradykinesia and rigidity is in effect)\n* Currently experiencing depressive symptoms\n* Able to attend all in-person visits at UCSF as well as virtual visits\n* Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating\n\nExclusion Criteria:\n\n* Psychotic symptoms involving loss of insight\n* Significant cognitive impairment\n* Regular use of medications that may have problematic interactions with psilocybin\n* A health condition that makes this study unsafe or unfeasible, determined by study physicians",[104,105],"ADULT","OLDER_ADULT",[107],{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":112,"contacts":113,"geoPoint":127},"University of California, San Francisco","San Francisco","California","94143","United States",[114,119,121,124],{"name":115,"role":116,"phone":117,"email":118},"Brigette Sosa","CONTACT","(415) 935-3489","pdp2@ucsf.edu",{"name":120,"role":116,"email":118},"Kimberly Sakai",{"name":122,"role":123},"Joshua Woolley, MD,PhD","PRINCIPAL_INVESTIGATOR",{"name":125,"role":126},"Ellen Bradley, MD","SUB_INVESTIGATOR",{"lat":128,"lon":129},37.77493,-122.41942,[131,132],{"name":115,"role":116,"phone":117,"email":118},{"name":125,"role":116},[134,135],{"name":122,"affiliation":108,"role":123},{"name":125,"affiliation":108,"role":123},[],[138],{"label":139,"url":140},"Click here to take our survey to see if you're eligible","http:\u002F\u002Ftiny.ucsf.edu\u002Fpdp2survey",{"nct_id":4,"conditions":142,"biomarkers":143},[20,19],[],{"nct_id":4,"found":15,"summary":145,"prompt_version":154},{"design":146,"status":147,"heading":6,"summary":148,"follow_up":149,"word_count":150,"commitments":151,"compensation":152,"drugs_mentioned":153},"This is a randomized controlled trial planning to enroll 60 participants. It will compare psilocybin with psychological support to pimavanserin or a placebo.","completed","This study is looking at whether psilocybin (a drug) can help improve depression in people with Parkinson's disease. You might be able to join if you are 40 to 80 years old, have been diagnosed with Parkinson's disease, and are currently experiencing symptoms of depression. Participants will receive a single dose of psilocybin, ranging from a low \"microdose\" to a higher dose, along with psychological support. Some participants will also receive pimavanserin or a placebo (an inactive substance). The main goal is to see if psilocybin improves depression symptoms within 30 days after the first dose. The current status of this study is unclear.","Follow-up will continue for 3 months after the second drug administration session.",104,"You would attend in-person visits at UCSF, complete two drug administration sessions, and have psychotherapy sessions before and after each drug dose. You will also have clinical assessments, brain imaging, non-invasive brain stimulation, and blood draws.","Not stated in the trial record.",[22,42],"v2"]