Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-01 @ 5:57 PM
Study NCT ID:
NCT01674868
Status:
WITHDRAWN
Last Update Posted:
2015-06-16
First Post:
2012-08-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D001037', 'term': 'Aphasia'}], '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'}, {'id': 'D013064', 'term': 'Speech Disorders'}, {'id': 'D007806', 'term': 'Language Disorders'}, {'id': 'D003147', 'term': 'Communication 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005473', 'term': 'Fluoxetine'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], '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0}}, 'statusModule': {'whyStopped': 'unable to find patients meeting inclusion/exclusion criteria', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-06', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-14', 'studyFirstSubmitDate': '2012-08-24', 'studyFirstSubmitQcDate': '2012-08-28', 'lastUpdatePostDateStruct': {'date': '2015-06-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fugl-Meyer Motor Scale (FMMS)', 'timeFrame': 'baseline to 90 days', 'description': 'change in FMMS score'}, {'measure': 'Fugl-Meyer Motor Scale (FMMS)', 'timeFrame': 'baseline to 180 days', 'description': 'change in FMMS'}], 'secondaryOutcomes': [{'measure': 'Western Aphasia Battery', 'timeFrame': 'baseline to 90 days', 'description': 'change in Western Aphasia Quotient'}, {'measure': 'Behavioral Inattention Test (BIT)', 'timeFrame': 'baseline to 90 days', 'description': 'change in BIT'}, {'measure': 'Behavioral Inattention Test (BIT)', 'timeFrame': 'baseline to 180 days', 'description': 'change in BIT'}, {'measure': 'Functional Independence Measure', 'timeFrame': 'baseline to discharge', 'description': 'change in FIM'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': 'baseline to 90 days'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'baseline to 90 days'}, {'measure': 'Western Aphasia Battery', 'timeFrame': 'baseline to 180 days', 'description': 'change in Western Aphasia Quotient'}, {'measure': 'Beck Depression Inventory', 'timeFrame': 'baseline to 180 days'}, {'measure': 'Fatigue Severity Scale', 'timeFrame': 'baseline to 180 days'}, {'measure': 'modified Rankin Scale', 'timeFrame': 'baseline to 90 days'}, {'measure': 'modified Rankin Scale', 'timeFrame': 'baseline to 180 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stroke', 'recovery', 'fluoxetine', 'aphasia', 'neglect', 'motor'], 'conditions': ['Stroke']}, 'descriptionModule': {'briefSummary': 'This pilot study will recruit 25 subjects to assess the feasibility of replicating the FLAME study (Chollet, et al. Lancet 2011), a randomized controlled trial (RCT) that assessed the effect of fluoxetine vs placebo on motor recovery after ischemic stroke, in an American sample of post-acute stroke patients. This trial will in addition examine the effect of treatment with fluoxetine versus placebo on concurrent deficits in language and hemispatial attention, as well as post-stroke fatigue and will evaluate the durability of observed effects. The results of this pilot trial will be used to develop power estimates for a larger trial and to evaluate recruitment and intervention completion rates for subjects in an American post-acute environment. There are two additional substudies: the first will use MRI to assess structural changes at the beginning and end of the intervention; the second will examine the relationship of serum biomarkers of inflammation to the intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ischemic infarction within 15 days\n* Admission NIHSS item 5 score equal to or \\>2 -Able to give informed consent, with surrogate consent acceptable-\n\nExclusion Criteria:\n\n* Pre-stroke modified Rankin Scale score equal or .3\n* Pregnant or lactating\n* Taking an SSRI on admission to SRH\n* Taking a medication likely to have adverse interaction with an SSRI\n* Unable to return for follow-up testing days 90,180\n* Concurrent medial condition likely to worsen patient's functional status over next 6 months\n* Unable to competently participate in testing for 45min-2hrs with rest breaks\n* for MRI substudy: contraindication to MRI"}, 'identificationModule': {'nctId': 'NCT01674868', 'acronym': 'FLAN', 'briefTitle': 'Fluoxetine for Motor, Aphasia, and Neglect Recovery After Ischemic Stroke', 'organization': {'class': 'OTHER', 'fullName': 'Spaulding Rehabilitation Hospital'}, 'officialTitle': 'Pilot RCT of Fluoxetine vs Placebo to Treat Motor, Language and Unilateral Neglect After Ischemic Stroke', 'orgStudyIdInfo': {'id': 'FLAN SpauldingRH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fluoxetine', 'description': 'Subjects will take 20 mg fluoxetine daily for 90 days after stroke', 'interventionNames': ['Drug: fluoxetine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Subjects will take one pill daily for 90 days after stroke.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'fluoxetine', 'type': 'DRUG', 'description': '20 mg daily for 90 days starting day 5-10 after stroke.', 'armGroupLabels': ['Fluoxetine']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'subjects will take one pill po daily for 90 days.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Spaulding Rehabilitation Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Spaulding Rehabilitation Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Director, Stroke Program', 'investigatorFullName': 'Randie Black-Schaffer MD', 'investigatorAffiliation': 'Spaulding Rehabilitation Hospital'}}}}