Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2025-12-27 @ 8:03 PM
Study NCT ID:
NCT01561092
Status:
WITHDRAWN
Last Update Posted:
2012-06-19
First Post:
2012-03-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Escitalopram Treatment In Acute Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'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': 'D000089983', 'term': 'Escitalopram'}, {'id': 'D003909', 'term': 'Dexetimide'}], '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'}, {'id': 'D010881', 'term': 'Piperidones'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study medication could not be supplied. An alternative project will be conducted', 'overallStatus': 'WITHDRAWN', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'lastUpdateSubmitDate': '2012-06-18', 'studyFirstSubmitDate': '2012-03-20', 'studyFirstSubmitQcDate': '2012-03-20', 'lastUpdatePostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'New vascular events', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Death of any cause', 'timeFrame': '6 months'}, {'measure': 'Myocardial Infarction', 'timeFrame': '6 months'}, {'measure': 'Re-stroke', 'timeFrame': '6 months'}, {'measure': 'Motor function', 'timeFrame': '6 months', 'description': 'Fugl-Meyer Motor score is performed'}, {'measure': 'White Matter lesions', 'timeFrame': '6 months', 'description': 'Evaluated on MRI'}, {'measure': 'Bleeding complications', 'timeFrame': '6 months'}, {'measure': 'Combined vascular death', 'timeFrame': '6 months'}, {'measure': 'Cognitive abilities', 'timeFrame': '6 months', 'description': 'SDMT and MMSE tests are performed'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Stroke', 'RCT', 'SSRI', 'Outcome'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'Growing international scientific evidence has indicated a positive effect of SSRI treatment (serotonin reuptake inhibitors) after stroke, beyond its antidepressant effect. We wish to conduct a prospective randomised double blind placebo-controlled multicenter study of the combined neuroprotective and antithrombotic effects of SSRI treatment after stroke. Deletion of the SERT (serotonin transporter) gene may influence this treatment effect and may in itself be a risk factor for stroke, an aspect we also wish to explore.\n\nHypotheses:\n\n1. SSRI treatment commenced in the acute phase of stroke (day 2-5) protects against new thromboembolic events and leads to better rehabilitation.\n2. A specific SERT genotype is associated with an increased risk of first ever stroke.\n3. A specific SERT genotype is associated with a higher risk of post stroke depression.\n\n600 stroke patients will be randomised to either escitalopram or placebo treatment in a 1:1 ratio and genotyped according to SERT polymorphisms. The treatment and follow up period is 6 months. During these 6 months there will be 2 clinical follow up visits, one telephone control and one visit to evaluate compliance regarding medication. Patients who had an MRI as a part of the routine investigations done upon admission (approximately 300 patients) will have a control MRI after 6 months.\n\nAdditionally 400 patients, not eligible for participation i the randomised controlled trial, will be genotyped and answer questionnaires after 1 and 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* First ever ischemic stroke\n* Age 18 years or above\n\nExclusion Criteria\n\n* Hemorrhagic stroke\n* Dementia or other neurodegenerative disease\n* Antidepressant treatment within 6 months of admission\n* Acute need for antidepressant treatment\n* Drug abuse or other conditions that may indicate noncompliant behavior\n* Liver failure (increased liver enzyme levels up to or more than 2 times upper limit)\n* Renal failure (GFR under 30)\n* Hyponatremia (S-potassium below 130 mmol/l)\n* Actively bleeding ulcer\n* Fatal stroke or other severe co morbidity that markedly decreases expected life span\n* Prolonged QT interval (QTc above 500 ms)\n* Ongoing treatment with drugs known to prolong the QT interval'}, 'identificationModule': {'nctId': 'NCT01561092', 'acronym': 'ESTIAS', 'briefTitle': 'Escitalopram Treatment In Acute Stroke', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Efficacy of Escitalopram Treatment in Acute Stroke and the Role of SERT Genotype in Stroke', 'orgStudyIdInfo': {'id': '397-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Escitalopram', 'interventionNames': ['Drug: Escitalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Non active drug', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Escitalopram', 'type': 'DRUG', 'otherNames': ['SSRI', 'Cipralex'], 'description': '5 or 10 mg escitalopram tablets administered orally once daily', 'armGroupLabels': ['Escitalopram']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Tablets', 'armGroupLabels': ['Non active drug']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Aalborg', 'country': 'Denmark', 'facility': 'Neurology Department, Aalborg Hospital', 'geoPoint': {'lat': 57.048, 'lon': 9.9187}}, {'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Neurology Department, University Hospital of Aarhus', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Neurology Department, Glostrup Hospital', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Grethe Andersen, Prof. DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Aarhus, Neurology Dept.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}