Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 9:32 PM
Study NCT ID:
NCT00360633
Status:
COMPLETED
Last Update Posted:
2019-05-10
First Post:
2006-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psychiatric and Cognitive Manifestations of Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D007174', 'term': 'Disruptive, Impulse Control, and Conduct Disorders'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D053609', 'term': 'Lethargy'}, {'id': 'D020820', 'term': 'Dyskinesias'}], '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'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-08', 'studyFirstSubmitDate': '2006-08-02', 'studyFirstSubmitQcDate': '2006-08-02', 'lastUpdatePostDateStruct': {'date': '2019-05-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-08-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Non-motor symptom progression', 'timeFrame': 'Chronic'}], 'secondaryOutcomes': [{'measure': 'Motor symptom progression', 'timeFrame': 'Chronic'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Parkinson's Disease", 'Impulse control disorder', 'Dopamine agonist withdrawal syndrome', 'Anxiety', 'Depression', 'Healthcare Utilization', 'Disability', 'Quality of life', 'Cognitive function', 'Psychosis', 'Apathy', 'Dyskinesias', 'Wearing off'], 'conditions': ["Parkinson's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://parkinson.med.nyu.edu/', 'label': "NYU Parkinson's Disease and Movement Disorders Center"}]}, 'descriptionModule': {'briefSummary': "Parkinson's Disease (PD) is often thought of as affecting movement only. In fact, most patients also experience psychiatric and cognitive symptoms, sometimes from the disease itself, and sometimes as a side-effect of PD medications. The goals of this study are to evaluate the causes, effects, and clinical correlates of psychiatric and cognitive symptoms in PD.", 'detailedDescription': "Parkinson's Disease (PD) is defined by the presence of motor symptoms, but in recent years there has been increasing recognition of non-motor manifestations, including anxiety, depression, and cognitive symptoms. In addition, PD medications have been shown to cause impulse control disorders, cognitive changes, and non-motor withdrawal symptoms (dopamine agonist withdrawal syndrome) when they are discontinued. The goals of this study are to test the hypothesis that the presence of psychiatric and cognitive symptoms are associated with greater self-perceived disability (out of proportion to objective deficits), increased utilization of healthcare resources, and decreased quality of life. In addition, we will examine the clinical correlates of these psychiatric symptoms. To test these hypotheses, we will screen PD patients for anxiety, depression, impulse control disorders, and dopamine agonist withdrawal syndrome, and compare cases and controls with regard to demographic characteristics, motor features of PD, disability, healthcare utilization, and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "1. Patients with Parkinson's Disease who are seen for their routine medical care at the NYU Parkinson's and Movement Disorders Center.\n2. Matched healthy control subjects.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of idiopathic Parkinson's Disease (or healthy control subject)\n* Age \\>=21 and \\<=99\n* Capacity to provide informed consent\n* Ability to complete the questionnaires\n\nExclusion Criteria:\n\n* Clinical diagnosis of dementia\n* Terminal illness (life expectancy \\< 12 months)\n* Presence of a neurodegenerative disorder other than Parkinson's Disease"}, 'identificationModule': {'nctId': 'NCT00360633', 'briefTitle': "Psychiatric and Cognitive Manifestations of Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': "Psychiatric and Cognitive Manifestations of Parkinson's Disease: A Prospective Cohort Study", 'orgStudyIdInfo': {'id': '12-03082'}}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Melissa J Nirenberg, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}