Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2025-12-26 @ 2:15 AM
Study NCT ID:
NCT00298805
Status:
TERMINATED
Last Update Posted:
2013-08-12
First Post:
2006-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Quality of Life Study in Patients With Migraines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'whyStopped': 'Study terminated due to expiration of IRB approval', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-08', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-08', 'studyFirstSubmitDate': '2006-03-01', 'studyFirstSubmitQcDate': '2006-03-01', 'lastUpdatePostDateStruct': {'date': '2013-08-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dysphoric-like depressive characteristics in patient with epilepsy', 'timeFrame': 'N/A (cross-sectional study)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Migraine', 'Headache', 'Depression', 'Quality of Life'], 'conditions': ['Migraine', 'Headache', 'Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare depressive characteristics in migraine patients to those observed in patients with epilepsy in a previous study, and determine whether those symptoms are unique to patients with epilepsy.', 'detailedDescription': 'A form of depression known as dysphoric-like disorder is common in people with epilepsy, which may significantly affect the quality of life in these people, as shown in a previous study. However, it is unclear if this depressive disorder is unique to patients with epilepsy. In order to assess whether these symptoms are unique and idiosyncratic to the epilepsy population, in this multi-center study, these dysphoric depressive features will be contrasted to those seen in patients with other neurologic or psychiatric conditions. Migraine is selected as one of the comparison disorders because it shares with epilepsy characteristics of being a recurrent episodic central nervous system disorder, and our site will only enroll patients with migraine headaches.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Migraine patients will be recruited from the outpatient neurology clinics / offices.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female 18 years of age or older\n* Have the diagnosis of migraine\n* Have had no change in migraine medication(s) 30 days prior to study\n* Achieve a satisfactory score on the Wide Range Achievement Test 3 (WRAT3) test at the screening visit\n* Capable of completing self-reporting questionnaires\n* Willing and able to provide written informed consent and comply with the study protocol\n\nExclusion Criteria:\n\n* Presence of a clinically significant comorbidity of an unstable or progressive nature\n* Presence of major depression\n* Participation in an investigational drug study within the past 30 days\n* Inability to communicate well with site study personnel'}, 'identificationModule': {'nctId': 'NCT00298805', 'briefTitle': 'A Quality of Life Study in Patients With Migraines', 'organization': {'class': 'OTHER', 'fullName': 'Northwell Health'}, 'officialTitle': 'Dysphoric-like Disorder of Epilepsy, Is It Unique?', 'orgStudyIdInfo': {'id': '05.02.073'}}, 'contactsLocationsModule': {'locations': [{'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Long Island Jewish Health System', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}], 'overallOfficials': [{'name': 'Andres M Kanner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwell Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rush University Medical Center', 'class': 'OTHER'}, {'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}