Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-01-05 @ 6:24 PM
Study NCT ID:
NCT06086366
Status:
UNKNOWN
Last Update Posted:
2023-10-17
First Post:
2023-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Presynaptic Imaging in Major Depressive Episodes After COVID-19
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000094024', 'term': 'Post-Acute COVID-19 Syndrome'}, {'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D059445', 'term': 'Anhedonia'}], 'ancestors': [{'id': 'D000086382', 'term': 'COVID-19'}, {'id': 'D011024', 'term': 'Pneumonia, Viral'}, {'id': 'D011014', 'term': 'Pneumonia'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018352', 'term': 'Coronavirus Infections'}, {'id': 'D003333', 'term': 'Coronaviridae Infections'}, {'id': 'D030341', 'term': 'Nidovirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D000094025', 'term': 'Post-Infectious Disorders'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-15', 'studyFirstSubmitDate': '2023-09-05', 'studyFirstSubmitQcDate': '2023-10-15', 'lastUpdatePostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vesicular Monoamine Transporter 2 Binding Potential (VAMT2 BPND)', 'timeFrame': 'within 3 to 4 weeks after initiation of screening', 'description': 'The investigators will determine if VMAT2 BPND is changed in ventral striatum and dorsal putamen in COVID-DNP.'}, {'measure': 'Synaptic Vesicle Glycoprotein 2A Total Distribution Volume (SV2A VT)', 'timeFrame': 'within 3 to 4 weeks after initiation of screening', 'description': 'The investigators will determine if SV2A VT is changed in ventral striatum and dorsal putamen in COVID-DNP'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET', 'Long COVID', 'Major Depressive Disorder', 'Major Depressive Episode', 'Anhedonia', 'Dopamine Neuron Loss'], 'conditions': ['Long COVID', 'Major Depressive Disorder', 'Major Depressive Episode']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study focuses on understanding and addressing a subset of persistent neuropsychiatric symptoms occurring within 3 months after mild to moderate COVID-19 infection (COVID-DNP). COVID-DNP encompasses major depressive episodes (MDE) with or without additional neuropsychiatric symptoms.', 'detailedDescription': 'Participants will undergo two positron emission tomography (PET) scans, one \\[11C\\]DTBZ scan (for vesicular monoamine transporter 2 (VMAT2) and one \\[18F\\]SDM8 scan (for synaptic vesicle glycoprotein 2A (SV2A)), as well as one magnetic resonance imaging (MRI) scan.\n\nThe main question\\[s\\] it aims to answer are:\n\n1. The investigators will determine if VMAT2 binding potential (VMAT2 BPND) is reduced in ventral striatum and dorsal putamen in COVID-DNP.\n2. The investigators will determine if SV2A total distribution volume (SV2A VT) is reduced in ventral striatum and dorsal putamen in COVID-DNP'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recovered from mild to moderate COVID-19 respiratory symptoms with subsequent onset of COVID-DNP', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* New onset MDE within 3 months after mild or moderate COVID-19, with MDE verified by the research version SCID for DSM 5. See "Positive COVID-19 diagnosis" listed after inclusion/exclusion criteria for a description of how this is determined.\n* Age 18 to 75.\n* Good general physical health with no active medical conditions based on self-report (except migraine or PASC).\n\nExclusion Criteria:\n\n* Use of antidepressants in the previous month (6 weeks for fluoxetine).\n* Use of stimulant medication affecting dopamine release in the previous month\n* Use of antipsychotics in the previous month\n* History of neurological disease (except migraine, and PASC) based on self-report\n* Use of medications or herbal products or natural health products with central nervous system effects in past 2 weeks based on self-report\n* Presence of cigarette smoking in the past two months, based on self-report\n* Lifetime diagnosis of severe Substance or Alcohol Use Disorder, or diagnosis of mild to moderate Substance or Alcohol Use Disorder in the past two years, based on self-report and verified by the Research Version of Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID-5-RV)\n* Use of recreational drugs, including marijuana, in the past two months, based on self-report and verified by the Research Version of Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID-5-RV)\n* Positive urine drug or cotinine screen at any timepoint during the study\n* History of psychotic symptoms secondary to schizophrenia, schizophreniform, bipolar disorder, or brief psychotic disorder prior to COVID-19, based on self-report and verified by the Research Version of Structured Clinical Interview for Diagnostic and Statistical Manual-5 (SCID-5-RV)\n* Currently pregnant, based on self-report or positive pregnancy test at any timepoint during the study, in females (in our PET Centre females up to 65 years of age are given a urine pregnancy test prior to every PET scan)\n* Breastfeeding (for females)\n* Current disorders of coagulation, blood or ongoing use of anticoagulant medication, based on self-report\n* Claustrophobia, based on self-report\n* Weight over 400lbs and height over 7ft (requirements for fitting in the scanners and hospital gowns)\n* Presence of metal implant, object or electrical devices that are contraindicated for MRI, based on self-report\n* Severe allergic reaction to alcohol'}, 'identificationModule': {'nctId': 'NCT06086366', 'acronym': 'PCOV', 'briefTitle': 'Presynaptic Imaging in Major Depressive Episodes After COVID-19', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'Presynaptic Imaging in Major Depressive Episodes After COVID-19', 'orgStudyIdInfo': {'id': 'REB#201/2022'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-DNP', 'description': 'Participants that have recovered from mild or moderate COVID-19 respiratory symptoms and have a new onset major depressive episode (MDE).', 'interventionNames': ['Other: [11C]DTBZ PET scan', 'Other: [18F]SDM8 PET scan', 'Other: MRI scan']}, {'label': 'Healthy Control', 'description': 'Participants in good physical health, age- and sex-matched to Group 1 and 2 participants.', 'interventionNames': ['Other: [11C]DTBZ PET scan', 'Other: [18F]SDM8 PET scan', 'Other: MRI scan']}], 'interventions': [{'name': '[11C]DTBZ PET scan', 'type': 'OTHER', 'description': 'One \\[11C\\]DTBZ scan for vesicular monoamine transporter 2 (VMAT2)', 'armGroupLabels': ['COVID-DNP', 'Healthy Control']}, {'name': '[18F]SDM8 PET scan', 'type': 'OTHER', 'description': 'One \\[18F\\]SDM8 scan for synaptic vesicle glycoprotein 2A (SV2A)', 'armGroupLabels': ['COVID-DNP', 'Healthy Control']}, {'name': 'MRI scan', 'type': 'OTHER', 'description': 'One MRI scan', 'armGroupLabels': ['COVID-DNP', 'Healthy Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Yuhan Liu', 'role': 'CONTACT', 'email': 'yuhan.liu@camh.ca', 'phone': '(416) 535-8501 ext. 39674'}], 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Karida Liu', 'role': 'CONTACT', 'email': 'liuyuhan0830@gmail.com', 'phone': '416-535-8501', 'phoneExt': '39674'}, {'name': 'Jeffrey Meyer', 'role': 'CONTACT', 'email': 'jeffrey.meyer@utoronto.ca', 'phone': '416-535-8501', 'phoneExt': '34007'}], 'overallOfficials': [{'name': 'Jeffrey Meyer, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Scientist and Head, Neurochemical Imaging Program in Mood and Anxiety Disorders, Brain Health Imaging Centre, Campbell Family Mental Health Research Institute', 'investigatorFullName': 'Jeff Meyer', 'investigatorAffiliation': 'Centre for Addiction and Mental Health'}}}}