Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT02983318
Status:
COMPLETED
Last Update Posted:
2020-04-09
First Post:
2016-11-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Molecular Imaging of Brain Inflammation in Depressive Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'NONE_RETAINED', 'description': 'Blood drawn and analyzed'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-07', 'studyFirstSubmitDate': '2016-11-29', 'studyFirstSubmitQcDate': '2016-12-02', 'lastUpdatePostDateStruct': {'date': '2020-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'inflammation-related excitotoxicity in the brain', 'timeFrame': 'single time. Data collected at baseline with no follow up.', 'description': 'Cross sectional MRI/PET scan will be used to identify inflammation related excitotoxicity in the brain in healthy individuals and those diagnosed with major depression.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depressive Disorder, Major', 'Positron-Emission Tomography']}, 'descriptionModule': {'briefSummary': "In a number of neuropsychiatric disorders such as depression, both brain inflammation and glutamate mediated excitotoxicity (cell death through over-activated stimulation) are suspected to play a key role. It is difficult, if not impossible, to determine the potential destructiveness of the inflammatory response seen in disease states by studying the brain's inflammatory cells (microglia) activity in isolation. The investigators are proposing to develop the means to concurrently study inflammatory response (i.e., microglial activity) and its potentially devastating consequence (i.e., glutamate excitotoxicity) across the entire brain in order to establish the importance of inflammation. In this study the investigators propose a phased clinical study whereby the early-phase involves the development of our capacity to study inflammation-mediated damage to brain cells, followed by a feasibility study in patients with clinical depression that tests whether concurrent inflammation and glutamate excess could be measured in key brain regions associated with a depressed mood state."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Able to pass MRI screening form (reviewed by a MRI technician)\n* diagnosed with depression or healthy control participants with no present mental health disorder\n* Good general health with no diseases expected to interfere with the study\n* Subject is not pregnant, lactating, or of childbearing potential (must be practising effective form of birth control)\n* Patient and healthy controls must not have an infection or an autoimmune disorder or persistent inflammation.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* screening form for MRI/PET is satisfactory after being reviewed by a radiologist\n* diagnosed with depression or healthy control participants with no present mental health disorder\n* Good general health with no diseases expected to interfere with the study\n* Subject is not pregnant, lactating, or of childbearing potential (must be practicing effective form of birth control)\n* Patient and healthy controls must not have an infection or an autoimmune disorder or persistent inflammation.\n\nExclusion Criteria:\n\n* Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the protocol\n* use of Investigational agents within last month'}, 'identificationModule': {'nctId': 'NCT02983318', 'acronym': 'DiME', 'briefTitle': 'Molecular Imaging of Brain Inflammation in Depressive Disorders', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Molecular Imaging of Brain Inflammation in Depressive Disorders', 'orgStudyIdInfo': {'id': '100128'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PET/MRI using 18[F]EPPA ligand', 'description': 'given experimental ligand FEPPA during MRI/PET scan to identify glutamate activity in the brain using FEPPA ligand'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 4V2', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "St Joseph's Hospital", 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Lena Palaniyappan, MBBS/PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}