Ignite Creation Date:
2025-12-25 @ 4:20 AM
Ignite Modification Date:
2025-12-26 @ 3:21 AM
Study NCT ID:
NCT00254020
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2005-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015283', 'term': 'Citalopram'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2005-11-10', 'studyFirstSubmitQcDate': '2005-11-10', 'lastUpdatePostDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-11-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Centre for Epidemiological Studies-Depression Scale (CES-D)', 'timeFrame': 'Baseline, 6 weeks, 12 weeks'}, {'measure': 'Mini Mental State Examination (MMSE)', 'timeFrame': 'Baseline, 6 weeks, 12 weeks'}, {'measure': 'NINCDS-CSN Vascular Cognitive Impairment Battery', 'timeFrame': 'Baseline, 6 weeks, 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Modified Rankin Scale (mRS)', 'timeFrame': 'Baseline, 6 weeks, 12 weeks'}, {'measure': 'NIH Stroke Scale', 'timeFrame': 'Baseline, 6 weeks, 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'depression', 'cytokines', 'serotonin', 'citalopram'], 'conditions': ['Depression']}, 'referencesModule': {'references': [{'pmid': '25285006', 'type': 'RESULT', 'citation': 'Bensimon K, Herrmann N, Swardfager W, Yi H, Black SE, Gao FQ, Snaiderman A, Lanctot KL. Kynurenine and depressive symptoms in a poststroke population. Neuropsychiatr Dis Treat. 2014 Sep 22;10:1827-35. doi: 10.2147/NDT.S65740. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': "Depression is a common and often serious problem occurring in stroke patients. Inflammatory hormones, known as cytokines, are stimulated by an activated immune system and sometimes become active following a stroke. They may be responsible for altering levels of key neurotransmitters and their metabolites in the blood and brain of stroke patients. The investigators' objective is to examine whether increased cytokine activity following a stroke may be the cause of an increased presence or severity of depression or cognitive impairment among stroke patients, as a result of tryptophan depletion and/or kynurenine activation. They are recruiting patients within one month of their strokes and measuring levels of key markers in their blood. Patients are assessed for the presence of depressive and/or cognitive symptoms and treated with an antidepressant if needed. The investigators expect to show that cytokine activation is related to depression and/or cognitive impairment among stroke patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age \\> 18 years\n* Gender: male or female\n* Language: speaks and understands English\n* Clinical diagnosis of stroke according to World Health Organization MONICA Project and recent (\\< 3 months) cerebral infarctions\n* Written, informed consent\n* Depressed group only: diagnosis of a major depressive episode according to the depression module of the Structured Clinical Interview for the DSM-IV (SCID-IV)\n\nExclusion Criteria:\n\n* Subarachnoid hemorrhage\n* Intracranial hemorrhage\n* Significant acute medical illness including: drug overdose, severely disturbed liver, kidney or lung function, anemia, hypothyroidism, or uncontrolled diabetes\n* Significant acute neurologic illness including: impaired consciousness, Parkinson's disease, Huntington's chorea, progressive supranuclear paralysis, brain tumor, subdural hematoma, multiple sclerosis, hydrocephalus, Binswanger's disease, or severe aphasia\n* Presence of a premorbid Axis I psychiatric diagnosis (eg. schizophrenia, bipolar disorder)\n* Depressed group only: contraindications to receiving treatment with citalopram (including previous nonresponse) or serious risk of suicide"}, 'identificationModule': {'nctId': 'NCT00254020', 'briefTitle': 'The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression', 'organization': {'class': 'OTHER', 'fullName': 'Sunnybrook Health Sciences Centre'}, 'officialTitle': 'The Role of Cytokine-Serotonin Interactions in Post-Stroke Depression', 'orgStudyIdInfo': {'id': '380-2004'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Citalopram', 'type': 'DRUG', 'otherNames': ['Celexa'], 'description': 'Patients who are found to have major depression will be referred to a psychologist'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L4C 4Z3', 'city': 'Richmond Hill', 'state': 'Ontario', 'country': 'Canada', 'facility': 'York Central Hospital', 'geoPoint': {'lat': 43.87111, 'lon': -79.43725}}, {'zip': 'M2M 2G1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. John's Rehabilitation Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4G 1R7', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Rehabilitation Institute', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M4N 3M5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M6A 2E1', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Baycrest', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Krista L Lanctot, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}