Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT00518258
Status:
COMPLETED
Last Update Posted:
2013-05-17
First Post:
2007-08-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Neuroimaging Studies of Depression in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-05-16', 'studyFirstSubmitDate': '2007-08-16', 'studyFirstSubmitQcDate': '2007-08-16', 'lastUpdatePostDateStruct': {'date': '2013-05-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'Magnetic Resonance Imaging (MRI)', 'neuropsychological assessment'], 'conditions': ["Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to investigate similarities and differences in the neural pathways of depressed Parkinson's patients, non-depressed Parkinson's patients, and healthy controls using magnetic resonance imaging (MRI) of the brain and neuropsychological assessment.", 'detailedDescription': "Depression is a common and potentially serious complication of Parkinson's disease (PD). Studies show that approximately 40 percent of PD patients are depressed. There is evidence that these patients have deficits in neuropsychological function relative to non-depressed PD patients. Despite the widespread toll on emotional health posed by PD, few studies have undertaken a comprehensive examination of the neural underpinnings of Parkinsonian depression. In this project, we will compare depressed versus non-depressed Parkinson patients to a sample of demographically-matched healthy controls using neuropsychological assessment and magnetic resonance imaging (MRI). To investigate possible effects of anti-Parkinsonian medication on mood, cognitive function, and neural response, PD patients will be tested both off and on Parkinsonian medications."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Neurology clinics, community sample', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* right-handed\n* willing/able to undergo magnetic resonance imaging (MRI)\n\nExclusion Criteria:\n\n* history of neurological condition other than Parkinson's disease\n* history of psychiatric condition other than depression\n* history of substance abuse/dependence"}, 'identificationModule': {'nctId': 'NCT00518258', 'briefTitle': "Neuroimaging Studies of Depression in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Kentucky'}, 'officialTitle': "Neuroimaging Studies of Depression in Parkinson's Disease", 'orgStudyIdInfo': {'id': 'R01-MH78228-2'}, 'secondaryIdInfos': [{'id': 'R01MH078228', 'link': 'https://reporter.nih.gov/quickSearch/R01MH078228', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Patient Group'}, {'label': '2', 'description': 'Control Group'}]}, 'contactsLocationsModule': {'locations': [{'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}], 'overallOfficials': [{'name': 'Lee X. Blonder, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kentucky'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lee Blonder', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}, {'name': 'National Institute of Neurological Disorders and Stroke (NINDS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Lee Blonder', 'investigatorAffiliation': 'University of Kentucky'}}}}