Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-26 @ 6:34 AM
Study NCT ID:
NCT01477268
Status:
COMPLETED
Last Update Posted:
2011-11-22
First Post:
2009-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive Correlates of Antidepressant Treatment Response in Elders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020280', 'term': 'Sertraline'}, {'id': 'D000928', 'term': 'Antidepressive Agents'}], 'ancestors': [{'id': 'D015057', 'term': '1-Naphthylamine'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D011619', 'term': 'Psychotropic Drugs'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-05', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-11-18', 'studyFirstSubmitDate': '2009-06-09', 'studyFirstSubmitQcDate': '2011-11-18', 'lastUpdatePostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'depression', 'timeFrame': 'June 1, 2007 - June 1, 2008'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['antidepressants', 'depression', 'zoloft', 'psychiatry', 'psychology'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'Major depression is a very common health problem affecting older persons. The present standard of treatment is with medications called "antidepressants". Antidepressants have been studied extensively in older persons with normal brain function and have been shown to be effective. However, certain types of brain dysfunction called "executive impairment" (inability to do higher order thinking) may lead to poor treatment outcomes. This study will compare how older depressed people with different levels of executive impairment respond differently to standard antidepressant treatment. Knowing this information will lead to more rational targeting of available treatments, leading to improved treatment outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* above the age of 65,\n* speak English fluently,\n* experience depression, AND\n* not yet on active treatment.\n\nExclusion Criteria:\n\n* active delirium,\n* substance abuse,\n* mental illness other than major depression,\n* active CNS disease,\n* unstable systematic medical disease, OR\n* current of past psychotic disorder.'}, 'identificationModule': {'nctId': 'NCT01477268', 'briefTitle': 'Cognitive Correlates of Antidepressant Treatment Response in Elders', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Determining the Impact of Dementia and Executive Impairment on Antidepressant Treatment Response in Older Persons', 'orgStudyIdInfo': {'id': '06-296'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'zoloft', 'description': 'Both arms of the study will include zoloft. However, the treatment response to zoloft will be compared in two different subgroups.', 'interventionNames': ['Drug: Zoloft (antidepressant)']}], 'interventions': [{'name': 'Zoloft (antidepressant)', 'type': 'DRUG', 'otherNames': ['Sertraline'], 'description': 'Zoloft 50-200 mg po od x 12 weeks', 'armGroupLabels': ['zoloft']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B 1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Corinne Fischer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Michaels Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr. Corinne E. Fischer', 'oldOrganization': "St. Michael's Hospital"}}}}