[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07610369":3,"trial-entities:NCT07610369":202,"trial-summary:NCT07610369":206},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":9,"sponsor_name":11,"lead_sponsor_class":12,"has_dmc":13,"brief_summary":14,"detailed_description":15,"conditions":16,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":44,"secondary_outcomes":49,"sex":90,"minimum_age":91,"maximum_age":92,"healthy_volunteers":93,"eligibility_criteria":94,"std_ages":172,"locations":175,"central_contacts":194,"overall_officials":198,"references":200,"see_also_links":201},"NCT07610369","2000042396","The Efficacy of Psilocybin Therapy for Depression in Parkinson's Disease","RECRUITING","2030-07","2026-07","2026-07-20","Yale University","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. Investigators will enroll participants 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 will be used to quantify changes in depression as well as other relevant outcomes (non-motor and motor symptoms of PD, cognitive performance, quality of life). Follow-up will continue to 3 months after the second session. Endpoints will evaluate efficacy, safety, and tolerability of study procedures.\n\nAfter posting of these trial results, this data will be combined with the data from the trial at UCSF (NCT06455293) for publication purposes.",[17,18],"Depression","Parkinson's Disease (PD)",[20,17,21,22,23],"Parkinson's Diesease","Psilocybin","Psilocybin therapy","Movement disorder","INTERVENTIONAL","TREATMENT",[27],"PHASE2",{"count":29,"type":30},40,"ESTIMATED",[32,40],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":38},"DRUG","Psilocybin (drug)","Single dose of psilocybin ranging from low (\"microdose\") to high delivered orally with psychological support and monitoring",[37],"Psilocybin Administration Session 1",[39],"4-phosphoryloxy- N, N-dimethyltryptamine",{"type":33,"name":34,"description":35,"armGroupLabels":41,"otherNames":43},[42],"Psilocybin Administration Session 2",[39],[45],{"measure":46,"description":47,"timeFrame":48},"Change in depression as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)","MADRS is a 10-item clinician-administered scale used to measure the severity of depressive symptoms. Total scores range from 0 to 60 with higher scores indicating more severe depression.","Baseline to 30 days after first drug dose",[50,54,57,61,64,68,71,74,78,81,84,87],{"measure":51,"description":52,"timeFrame":53},"Adverse Events","Incidence, severity, and frequency of all Adverse Events (AEs) including Treatment-Emergent AEs (TEAEs) and Serious AEs (SAEs)","Baseline to 90 days after second drug dose",{"measure":55,"description":56,"timeFrame":53},"Changes in clinician-rated psychotic symptoms as measured by the Enhanced Scale for the Assessment of Positive Symptoms for Parkinson's Disease (eSAPS-PD)","The eSAPS-PD is a clinician-administered scale used to track Parkinson's Disease symptom severity. Scores range from 25 to 125, where higher scores indicate more impairment.",{"measure":58,"description":59,"timeFrame":60},"Subjective effects of psilocybin as measured by the 5-Dimensional Altered States of Consciousness Rating Scale (5D-ASC)","The 5D-ASC is a patient-reported scale used to measure the intensity of an experience during altered states of conciousness. Scores range from 0 to 100, where higher scores indicate more intense psychedelic effects.","Up to 30 and 60 days after Baseline",{"measure":62,"description":63,"timeFrame":53},"Suicidality as measured using the Columbia Suicide Severity Rating Scale (C-SSRS)","The C-SSRS is a clinician-administered scale used to assess suicide risk. Scores range from 0 to 6, where higher scores indicate more severe suicide risk.",{"measure":65,"description":66,"timeFrame":67},"Participant -reported acceptability of study procedures as measured by the study-specific Treatment Satisfaction Questionnaire-Participant (TSQ-P)","TSQ-P is a patient-reported 7-point scale used to measure patients' satisfaction with their medication. Scores range from 0 to 7, where higher scores indicate greater satisfaction.","30 days after second drug dose",{"measure":69,"description":70,"timeFrame":53},"Changes in depression severity as measured by Montgomery-Asberg Depression Rating Scale (MADRS)","MADRS is a 10-item clinician-administered scale used to measure the severity of depression symptoms. Overall score ranges from 0 to 60, where higher scores indicate more severe depression.",{"measure":72,"description":70,"timeFrame":73},"Proportion of participants with a response (defined as a >\u002F=50% decrease in MADRS total score) as measured by the Montgomery-Asberg Depression Rating Scale (MADRS)","7 days after first drug dose and up to 90 days after second drug dose",{"measure":75,"description":76,"timeFrame":77},"Changes in participant reported depression as measured by the Beck Depression Inventory (BDI-II)","BDI-II is a 21-item patient-reported questionnaire used to assess the severity of depressive symptoms. Total scores range from 0 to 63, with higher scores indicating more severe depression.","Baseline up to 90 days after second drug dose",{"measure":79,"description":80,"timeFrame":53},"Changes in anxiety as measured by the Parkinson Anxiety Scale (PAS)","PAS is a 12-item, PD-specific scale used to assess anxiety in adults with Parkinson's disease. Total scores range from 0 to 50 with higher scores indicating more severe anxiety.",{"measure":82,"description":83,"timeFrame":53},"Changes in PD symptom severity as measured by the Movement Disorder Society revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)","MDS-UPDRS is a 50-item scale used for assessing both motor and non-motor aspects of Parkinson's disease. Total scores range from 0 to 176 with higher scores indicating more severe disease.",{"measure":85,"description":86,"timeFrame":53},"Changes in cognitive performance as measured by multi-task assessments to include Probabilistic Reversal Task, Category Switch Task, Simon Task, Delay Discounting Task, California Verbal Learning Test-II, Digit span forward and backward","Probabilistic Reversal Task measures flexible learning, Category Switch Task measures mental set shifting, Simon Task measures selective attention, Delay Discounting Task measures impulse control\u002Fwaiting for rewards, California Verbal Learning Test (CVLT-II) measures short- and long-term memory, Digit Span Forward and Backward measures working memory.",{"measure":88,"description":89,"timeFrame":53},"Changes in Quality of Life as measured by the 36-item Short Form survey (SF-36)","SF-36 is a patient-reported 36-item scale used to measure health-related quality of life. Total scores range from 0 to 100 with higher scores indicating better health.","ALL","40 Years","80 Years",false,{"inclusion":95,"exclusion":110,"raw_text":171},[96,97,98,99,100,101,102,103,104,105,106,107,108,109],"Able to understand and provide informed consent","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)","Have no changes in medication or major surgical procedures anticipated for treatment duration","Have a score \\>\u002F=20 on the Beck Depression Inventory-2 (BDI-2), consistent with moderate or greater depressive symptom severity, at Baseline.","For people who can become pregnant: agree to use highly effective contraception from entry into the trial through Day B30 assessments (4 weeks after the second psilocybin administration session) and agree to not breastfeed. Acceptable methods of contraception are: An intrauterine device (IUD), hormone-based contraceptives (birth control pills) , condoms (internal or external) must be used with another method (other than spermicide), and complete abstinence from sexual activity that could result in pregnancy.","Agree that for one week preceding each psilocybin session, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and assessed for safety. Agree to abstain from all tobacco and nicotine use for the duration of the study.","Agree to consume approximately the same amount of caffeine-containing beverages that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions.","Agree to avoid sedative-hypnotic medications (e.g., benzodiazepines, zolpidem, zopiclone, zaleplon) taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.","Agree to avoid opioid medications taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.","Agree not to use products or substances containing Δ9-tetrahydrocannabinol (THC) and\u002For cannabidiol for at least 7 days prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.","Agree to not use non-prescribed narcotics (eg. heroine, fentanyl), depressants (eg. Barbiturates, benzodiazepines) and\u002For inhalants for the duration of participation in the trial.","Agree not to consume alcoholic beverages for at least 24 hours prior to and 24 hours following each psilocybin administration session.","Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating care and is available for consultation with the study medical monitor.",[111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170],"Any indication of forms of parkinsonism other than idiopathic Parkinson's disease.","Cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \\\u003C24.","Symptomatic orthostatic hypotension.","Currently receiving electroconvulsive therapy (ECT) or treatment via transcranial magnetic stimulation (TMS). Previous treatment with ECT and\u002For TMS is permitted; last treatment must be at least 30 days prior to entry into this trial.","Treatment in a clinical trial within 30 days of entry into this trial or treatment with another investigational drug or other intervention within 30 days or 5 half-lives, whichever is longer, prior to entry into this trial.","Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial.","Current severity of psychiatric symptoms warranting immediate treatment as determined by the study medical staff (e.g. due to inability to provide for basic needs\u002Fsafety). The study medical staff will assess these individuals, determine the appropriate level of care, and coordinate with the individual's primary providers to ensure close follow-up.","High risk of self-harm\u002Fsuicide, as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) risk screen, specifically: participant answers \"yes\" to item 4 or 5 suggesting intent to act on suicidal thoughts OR participant has made a serious suicide attempt within the 12 months prior to entry into this trial.","History of meeting DSM-5 criteria for a schizophrenia spectrum disorder, other psychotic disorder, or a mood disorder with psychotic features.","History of delusional symptoms or any other psychotic symptoms accompanied by a loss of insight. Exceptions may be made at the investigators' discretion in cases of a history of psychotic symptoms that were attributable to substance or medication use.","Current delusional symptoms or any other psychotic symptoms accompanied by a loss of insight.","History of a schizophrenia spectrum disorder in a first-degree relative.","History of bipolar disorder 1 in a first-degree relative, in whom illness onset was prior to age 40.","Current or history of meeting DSM-5 criteria for a bipolar disorder.","Current or history within the last 2 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder, excluding caffeine.","Currently meeting DSM-5 criteria for another psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin treatment procedures as determined by the investigators.","History of meeting DSM-5 criteria for Hallucinogen Persisting Perception Disorder (HPPD).","History of using any psychedelic substances including psilocybin, lysergic acid diethylamide (LSD), mescaline (and natural products containing mescaline including peyote and San Pedro cactus), N,N-Dimethyltryptamine (DMT), natural products containing DMT including ayahuasca and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 2C compounds, 3,4-methylenedioxy-methamphetamine (MDMA), or methylone during the past 6 months at dosages and\u002For frequencies determined clinically significant by the investigators.","Cancer with known central nervous system (CNS) involvement, CNS infection, or other major CNS disease aside from PD.","Epilepsy or other seizure disorder in adulthood.","Supplemental oxygen requirement.","Allergy or intolerance to any of the materials contained in the drug products.","Renal insufficiency defined as creatinine clearance \\\u003C 40 ml\u002Fmin using Cockraft and Gault equation","Insufficiently managed endocrine conditions, including diabetes mellitus and clinically significant thyroid dysfunction.","Cardiovascular conditions, including:","Elevated blood pressure defined as systolic blood pressure (SBP) \\>150 or diastolic blood pressure (DBP) \\>95 taken during Enrollment","Tachycardia defined as heart rate (HR) \\>90 beats per minute taken during Enrollment","Bradycardia defined as HR \\\u003C50 bpm taken during Enrollment","Angina","History of stroke within the past year","Clinically significant ECG abnormality as determined by the investigators, including but not limited to QTc \\> 450","Hepatic dysfunction as indicated by any of the following laboratory values:","AST \\> 3 x upper limit of normal","ALT \\> 3 x upper limit of normal","Total bilirubin \\> 3.0 mg\u002Fdl","Use of any of the following concomitant medications AND inability\u002Funwillingness to discontinue for at least 5 times the elimination half-life of the agent (specific exceptions are noted) prior to psilocybin administration, including:","Agents that may be associated with serotonin syndrome:","MAO inhibitors (participants must have discontinued 2 weeks prior to baseline)","St. John's Wort","S-adenosyl-methionine (SAM-e)","5-Hydroxytryptophan (5-HTP)","Dextromethorphan","Opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, tramadol)","Lithium","Linezolid","Buspirone","Agents that may interact with psilocybin metabolism\u002Feffects:","Serotonin antagonists (e.g., cyclobenzaprine, ondansetron)","Antipsychotics","Other dopamine antagonists (e.g., metoclopramide, promethazine, prochlorperazine)","Nicotine","Modulators of uridine diphosphate (UDP) or glucuronosyltransferase (UGT) (e.g. valproate, diclofenac, mefenamic acid, verapamil, ketoconazole, itraconazole, probenecid, phenobarbital, protease inhibitors)","L-methyl folate (\\>\u002F= 7.5mg\u002Fday)","Efavirenz","Agents that may increase the risk of psychotic symptoms:","Stimulants (e.g. modafinil, methylphenidate, atomoxetine, methamphetamine, cocaine, amphetamine derivatives)","Anticholinergics (e.g. benztropine, trihexyphenidyl, scopolamine, hyoscyamine)","Systemic steroids","Tricyclic antidepressants","Other medical condition or diagnosis, concomitant medication(s), physical exam finding, laboratory abnormality or health risk identified that precludes participation in study procedures due to safety or feasibility concerns at the discretion of the investigators.","Inclusion Criteria:\n\n* Able to understand and provide informed consent\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* Have no changes in medication or major surgical procedures anticipated for treatment duration\n* Have a score \\>\u002F=20 on the Beck Depression Inventory-2 (BDI-2), consistent with moderate or greater depressive symptom severity, at Baseline.\n* For people who can become pregnant: agree to use highly effective contraception from entry into the trial through Day B30 assessments (4 weeks after the second psilocybin administration session) and agree to not breastfeed. Acceptable methods of contraception are: An intrauterine device (IUD), hormone-based contraceptives (birth control pills) , condoms (internal or external) must be used with another method (other than spermicide), and complete abstinence from sexual activity that could result in pregnancy.\n* Agree that for one week preceding each psilocybin session, they will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement except when approved by the research team. Exceptions will be evaluated by the research team and assessed for safety. Agree to abstain from all tobacco and nicotine use for the duration of the study.\n* Agree to consume approximately the same amount of caffeine-containing beverages that they usually consume before arriving at the research unit on the mornings of psilocybin administration sessions.\n* Agree to avoid sedative-hypnotic medications (e.g., benzodiazepines, zolpidem, zopiclone, zaleplon) taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree to avoid opioid medications taken on an as-needed basis for a minimum of 5 half-lives prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree not to use products or substances containing Δ9-tetrahydrocannabinol (THC) and\u002For cannabidiol for at least 7 days prior to each psilocybin administration session and for 24 hours after each psilocybin administration session.\n* Agree to not use non-prescribed narcotics (eg. heroine, fentanyl), depressants (eg. Barbiturates, benzodiazepines) and\u002For inhalants for the duration of participation in the trial.\n* Agree not to consume alcoholic beverages for at least 24 hours prior to and 24 hours following each psilocybin administration session.\n* Have a primary care provider, neurologist, or psychiatrist who is actively managing or coordinating care and is available for consultation with the study medical monitor.\n\nExclusion Criteria:\n\n* Any indication of forms of parkinsonism other than idiopathic Parkinson's disease.\n* Cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \\\u003C24.\n* Symptomatic orthostatic hypotension.\n* Currently receiving electroconvulsive therapy (ECT) or treatment via transcranial magnetic stimulation (TMS). Previous treatment with ECT and\u002For TMS is permitted; last treatment must be at least 30 days prior to entry into this trial.\n* Treatment in a clinical trial within 30 days of entry into this trial or treatment with another investigational drug or other intervention within 30 days or 5 half-lives, whichever is longer, prior to entry into this trial.\n* Pregnancy as indicated by a positive urine pregnancy test during screening, lactation, or the intention of becoming pregnant within 3 months of entry into this trial.\n* Current severity of psychiatric symptoms warranting immediate treatment as determined by the study medical staff (e.g. due to inability to provide for basic needs\u002Fsafety). The study medical staff will assess these individuals, determine the appropriate level of care, and coordinate with the individual's primary providers to ensure close follow-up.\n* High risk of self-harm\u002Fsuicide, as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) risk screen, specifically: participant answers \"yes\" to item 4 or 5 suggesting intent to act on suicidal thoughts OR participant has made a serious suicide attempt within the 12 months prior to entry into this trial.\n* History of meeting DSM-5 criteria for a schizophrenia spectrum disorder, other psychotic disorder, or a mood disorder with psychotic features.\n* History of delusional symptoms or any other psychotic symptoms accompanied by a loss of insight. Exceptions may be made at the investigators' discretion in cases of a history of psychotic symptoms that were attributable to substance or medication use.\n* Current delusional symptoms or any other psychotic symptoms accompanied by a loss of insight.\n* History of a schizophrenia spectrum disorder in a first-degree relative.\n* History of bipolar disorder 1 in a first-degree relative, in whom illness onset was prior to age 40.\n* Current or history of meeting DSM-5 criteria for a bipolar disorder.\n* Current or history within the last 2 years of meeting DSM-5 criteria for a moderate or severe alcohol or drug use disorder, excluding caffeine.\n* Currently meeting DSM-5 criteria for another psychiatric condition judged to be incompatible with establishment of rapport or safe exposure to psilocybin treatment procedures as determined by the investigators.\n* History of meeting DSM-5 criteria for Hallucinogen Persisting Perception Disorder (HPPD).\n* History of using any psychedelic substances including psilocybin, lysergic acid diethylamide (LSD), mescaline (and natural products containing mescaline including peyote and San Pedro cactus), N,N-Dimethyltryptamine (DMT), natural products containing DMT including ayahuasca and 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), ibogaine, 2C compounds, 3,4-methylenedioxy-methamphetamine (MDMA), or methylone during the past 6 months at dosages and\u002For frequencies determined clinically significant by the investigators.\n* Cancer with known central nervous system (CNS) involvement, CNS infection, or other major CNS disease aside from PD.\n* Epilepsy or other seizure disorder in adulthood.\n* Supplemental oxygen requirement.\n* Allergy or intolerance to any of the materials contained in the drug products.\n* Renal insufficiency defined as creatinine clearance \\\u003C 40 ml\u002Fmin using Cockraft and Gault equation\n* Insufficiently managed endocrine conditions, including diabetes mellitus and clinically significant thyroid dysfunction.\n* Cardiovascular conditions, including:\n\n  * Elevated blood pressure defined as systolic blood pressure (SBP) \\>150 or diastolic blood pressure (DBP) \\>95 taken during Enrollment\n  * Tachycardia defined as heart rate (HR) \\>90 beats per minute taken during Enrollment\n  * Bradycardia defined as HR \\\u003C50 bpm taken during Enrollment\n  * Angina\n  * History of stroke within the past year\n  * Clinically significant ECG abnormality as determined by the investigators, including but not limited to QTc \\> 450\n* Hepatic dysfunction as indicated by any of the following laboratory values:\n\n  * AST \\> 3 x upper limit of normal\n  * ALT \\> 3 x upper limit of normal\n  * Total bilirubin \\> 3.0 mg\u002Fdl\n* Use of any of the following concomitant medications AND inability\u002Funwillingness to discontinue for at least 5 times the elimination half-life of the agent (specific exceptions are noted) prior to psilocybin administration, including:\n\n  * Agents that may be associated with serotonin syndrome:\n\n    * MAO inhibitors (participants must have discontinued 2 weeks prior to baseline)\n    * St. John's Wort\n    * S-adenosyl-methionine (SAM-e)\n    * 5-Hydroxytryptophan (5-HTP)\n    * Dextromethorphan\n    * Opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, tramadol)\n    * Lithium\n    * Linezolid\n    * Buspirone\n  * Agents that may interact with psilocybin metabolism\u002Feffects:\n\n    * Serotonin antagonists (e.g., cyclobenzaprine, ondansetron)\n    * Antipsychotics\n    * Other dopamine antagonists (e.g., metoclopramide, promethazine, prochlorperazine)\n    * Nicotine\n    * Modulators of uridine diphosphate (UDP) or glucuronosyltransferase (UGT) (e.g. valproate, diclofenac, mefenamic acid, verapamil, ketoconazole, itraconazole, probenecid, phenobarbital, protease inhibitors)\n    * L-methyl folate (\\>\u002F= 7.5mg\u002Fday)\n    * Efavirenz\n  * Agents that may increase the risk of psychotic symptoms:\n\n    * Stimulants (e.g. modafinil, methylphenidate, atomoxetine, methamphetamine, cocaine, amphetamine derivatives)\n    * Anticholinergics (e.g. benztropine, trihexyphenidyl, scopolamine, hyoscyamine)\n    * Systemic steroids\n  * Tricyclic antidepressants\n* Other medical condition or diagnosis, concomitant medication(s), physical exam finding, laboratory abnormality or health risk identified that precludes participation in study procedures due to safety or feasibility concerns at the discretion of the investigators.",[173,174],"ADULT","OLDER_ADULT",[176],{"facility":11,"status":7,"city":177,"state":178,"zip":179,"country":180,"contacts":181,"geoPoint":191},"New Haven","Connecticut","06510","United States",[182,187,189],{"name":183,"role":184,"phone":185,"email":186},"Sophie Holmes, PhD","CONTACT","203-685-4066","sophie.holmes@yale.edu",{"name":183,"role":188},"PRINCIPAL_INVESTIGATOR",{"name":190,"role":188},"Gerard Sanacora, MD",{"lat":192,"lon":193},41.30815,-72.92816,[195,196],{"name":183,"role":184,"phone":185,"email":186},{"name":190,"role":184,"email":197},"gerard.sanacora@yale.edu",[199],{"name":183,"affiliation":11,"role":188},[],[],{"nct_id":4,"conditions":203,"biomarkers":205},[17,204],"Parkinson Disease",[],{"nct_id":4,"found":13,"summary":207,"prompt_version":217},{"design":208,"status":209,"heading":210,"summary":211,"follow_up":212,"word_count":213,"commitments":214,"compensation":215,"drugs_mentioned":216},"This is a randomized controlled trial, meaning participants are assigned to groups by chance. It plans to enroll 40 participants to test psilocybin therapy.","completed","Psilocybin Therapy for Depression in Parkinson's Disease","This study is looking at whether psilocybin (a drug) can help improve depression symptoms in people with Parkinson's Disease (PD). You might be able to join if you are between 40 and 80 years old, have been diagnosed with Parkinson's Disease, and experience moderate to severe depression. The study will measure changes in your depression using a scale called the Montgomery-Asberg Depression Rating Scale (MADRS) over 30 days after your first dose. The current status of this study is unclear, and it plans to enroll 40 participants.","Follow-up will continue for 3 months after the second drug administration session.",87,"You would complete two drug administration sessions where you receive oral psilocybin with medical and psychological support. You would also have psychotherapy sessions before and after each drug session, with follow-up continuing for 3 months after the second session.","Not stated in the trial record.",[],"v2"]