[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06402955":3,"trial-entities:NCT06402955":88,"trial-summary:NCT06402955":93},{"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":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":42,"secondary_outcomes":47,"sex":52,"minimum_age":53,"maximum_age":54,"healthy_volunteers":15,"eligibility_criteria":55,"std_ages":59,"locations":62,"central_contacts":77,"overall_officials":85,"references":86,"see_also_links":87},"NCT06402955","2000037090","Imaging Depression in Parkinson's Disease","Identifying the Neural Basis of Depression in Parkinson's Disease","RECRUITING","2029-12-01","2026-03","2026-03-10","2024-09-01","Yale University","OTHER",true,"The goal of this observational study is to identify targetable neural substrates of depression in Parkinson's Disease for the first time in people with Parkinson's between the ages of 40 and 80, who are experiencing symptoms of depression.","This study will compare people with Parkinson's Disease and depression to individuals with Parkinson's Disease without Major Depressive Disorder, Major Depressive Disorder with no Parkinson's, and Healthy Controls. Up to 30 participants will be recruited and enrolled for each of these 4 groups. Participants will be asked to complete one PET and one MRI scan along with study assessments. Once screening and consent is completed, participants will be scheduled for PET and MRI scans. The total duration for participants in this study is 7 hours, including the screening visit and then one additional visit for the scans.\n\nThere will also be a small subset (opt-in) who will receive a single dose of ketamine to determine the ability of ketamine to target these mechanisms and initiate an associated antidepressant response. If the participant is opting into the ketamine arm, the investigators will ask them to come in for one single-dose of ketamine and complete another PET and MRI scan post-ketamine treatment.\n\nThe main questions it aims to answer are: 1) Will the Parkinson's depression group exhibit a distinct pattern of synaptic deficits compared to other groups? 2) Will there be differences in functional connectivity across groups? 3) Are there associations between synaptic density and functional connectivity across groups? 4) Will ketamine increase synaptic density in PD-affected and mood-related circuitry, and will that be associated with an antidepressant response?",[19,20],"Parkinson's Disease","Major Depressive Disorder",[22],"Imaging","INTERVENTIONAL","TREATMENT",[26],"PHASE2",{"count":28,"type":29},120,"ESTIMATED",[31,37],{"type":32,"name":33,"description":34,"armGroupLabels":35},"RADIATION","11C-UCB-J","Radiotracer for imaging",[36],"Parkinson's Disease with Major Depressive Disorder",{"type":38,"name":39,"description":40,"armGroupLabels":41},"DRUG","ketamine hydrochloride","There will be a small subset (opt-in) who will receive a single dose of ketamine to determine the ability of ketamine to target these mechanisms and initiate an associated antidepressant response. If the participant is opting into the ketamine arm, the investigators will ask them to come in for one single-dose of ketamine and complete another PET and MRI scan post-ketamine treatment.",[36],[43],{"measure":44,"description":45,"timeFrame":46},"Montgomery-Åsberg Depression Rating Scale (MADRS)","This assessment stratifies severity of depressive episodes in adults. Ratings are based on clinical interview with the patient. Use clinical judgment to determine whether the rating lies on the defined scale steps (0, 2, 4, 6 points) or between them (1, 3, 5 points, denoted as \"(Worsening symptoms)\").The MADRS scoring instructions indicate that a total score ranging from 0 to 6 indicates that the patient is in the normal range (no depression), a score ranging from 7 to 19 indicates \"mild depression,\" 20 to 34 indicates \"moderate depression,\" a score of 35 and greater indicates \"severe depression,\" and a total score of 60 or greater indicates \"very severe depression.\"","One day",[48],{"measure":49,"description":50,"timeFrame":51},"Binding potential (BPND)","Binding potential (BPND) reflects the ratio at equilibrium of specifically bound radioligand to that of non-displaceable radioligand in tissue. BPND maps will be generated using the simplified reference tissue method 2 (SRTM2) and the centrum semiovale (CS) as reference region.","One week","ALL","40 Years","80 Years",{"inclusion":56,"exclusion":57,"raw_text":58},[],[],"Inclusion Criteria:\n\n1. Age 40-80.\n2. For women of reproductive potential, a negative pregnancy test at screening and scanning\n3. For PD patients, clinical diagnosis of PD, able to consent and tolerate PET procedures\n4. For PD depression patients - at least moderate symptom severity as determined by at least 15 on the MADRS, which has shown maximum discrimination between depressed and non-depressed PD patients.\n5. For dPD patients undergoing ketamine, abstinence from drugs of abuse, other than alcohol, cannabis, nicotine and caffeine for the duration of the study. Patients with substance use disorders as defined by the DSM-5 will be excluded.\n\nExclusion Criteria:\n\n1. Dementia (Montreal Cognitive Assessment (MoCA) score \\\u003C21)\n2. A significant primary DSM-5 psychiatric disorder except for MDD\n3. A history of or current significant medical (e.g. cardiovascular, renal), or neurological (e.g. cerebrovascular, seizure, traumatic brain injury) illness other than PD that is unstable and significantly increase their risk and\u002For might affect the study objectives, as determined by study physicians.\n4. Prior radiation exposure for research purposes within such that participation in this study would place them over FDA limits for annual radiation exposure\n5. Medications affecting SV2A availability (e.g. levetiracetam)\n6. For dPD patients receiving ketamine, uncontrolled hypertension, defined as average blood pressure greater than or equal to 140 mmHg or an average diastolic blood pressure greater than or equal to 90 mmHg among those patients who have hypertension.\n7. Contraindications to MRI.\n8. For patients undergoing arterial sampling for the PET scan: Iodine allergy, bleeding disorder and\u002For use of blood thinning medication\n9. Inability to provide written informed consent according to the Yale Human Investigation Committee (HIC) guidelines in English.",[60,61],"ADULT","OLDER_ADULT",[63],{"facility":13,"status":8,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":74},"New Haven","Connecticut","06520","United States",[69],{"name":70,"role":71,"phone":72,"email":73},"Sophie Holmes, PhD","CONTACT","203-685-4066","sophie.holmes@yale.edu",{"lat":75,"lon":76},41.30815,-72.92816,[78,81],{"name":79,"role":71,"phone":80,"email":73},"Sophie Holmes","2036854066",{"name":82,"role":71,"phone":83,"email":84},"Libby DiDomizio","2039476313","libby.didomizio@yale.edu",[],[],[],{"nct_id":4,"conditions":89,"biomarkers":92},[90,91],"Parkinson Disease","Unipolar Depression",[],{"nct_id":4,"found":15,"summary":94,"prompt_version":104},{"design":95,"status":96,"heading":97,"summary":98,"follow_up":99,"word_count":100,"commitments":101,"compensation":102,"drugs_mentioned":103},"This is an interventional study comparing four groups of participants, with a planned enrollment of 120 people. There is also an optional subset of participants who will receive ketamine.","completed","Imaging Depression in Parkinson's Disease with 11C-UCB-J and Ketamine","This study aims to understand the brain changes linked to depression in people with Parkinson's disease (PD). Researchers will use a special imaging substance called 11C-UCB-J (a radiotracer for imaging) to compare brain activity in four groups: people with PD and depression, people with PD without depression, people with depression but no PD, and healthy individuals. The study is looking for participants aged 40-80. A small group of participants can also choose to receive a single dose of ketamine hydrochloride (a drug) to see if it affects these brain mechanisms and helps with depression. The main goal is to see if the Montgomery-Åsberg Depression Rating Scale (MADRS) scores improve, which would indicate a positive antidepressant response.","The primary endpoint, the Montgomery-Åsberg Depression Rating Scale (MADRS), is measured at one day.",116,"You would have one screening visit and one additional visit for PET and MRI scans, totaling about 7 hours. If you opt into the ketamine arm, you would have one additional visit for a single dose of ketamine and another set of PET and MRI scans.","Not stated in the trial record.",[33,39],"v2"]