{"protocolSection":{"identificationModule":{"nctId":"NCT02737930","orgStudyIdInfo":{"id":"RSRB00058133"},"organization":{"fullName":"University of Rochester","class":"OTHER"},"briefTitle":"Fluoxetine for Visual Recovery After Ischemic Stroke","officialTitle":"Fluoxetine for Visual Recovery After Ischemic Stroke","acronym":"FLUORESCE"},"statusModule":{"statusVerifiedDate":"2021-09","overallStatus":"TERMINATED","whyStopped":"Slow recruitment and lack of funding to expand to other sites.","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2016-05"},"primaryCompletionDateStruct":{"date":"2020-08","type":"ACTUAL"},"completionDateStruct":{"date":"2020-08","type":"ACTUAL"},"studyFirstSubmitDate":"2016-04-01","studyFirstSubmitQcDate":"2016-04-13","studyFirstPostDateStruct":{"date":"2016-04-14","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-08-04","resultsFirstSubmitQcDate":"2021-09-16","resultsFirstPostDateStruct":{"date":"2021-10-13","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-09-16","lastUpdatePostDateStruct":{"date":"2021-10-13","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR_INVESTIGATOR","investigatorFullName":"Bogachan Sahin","investigatorTitle":"Assistant Professor of Neurology","investigatorAffiliation":"University of Rochester"},"leadSponsor":{"name":"Bogachan Sahin","class":"OTHER"}},"oversightModule":{"isFdaRegulatedDrug":true,"isFdaRegulatedDevice":false},"descriptionModule":{"briefSummary":"The purpose of this study is to determine whether fluoxetine, a selective serotonin reuptake inhibitor commonly used for depression, enhances visual recovery after an acute ischemic stroke."},"conditionsModule":{"conditions":["Acute Stroke","Visual Field Loss"],"keywords":["Acute ischemic stroke","Homonymous hemianopia","Homonymous quadrantanopia","Visual field loss","Post-stroke recovery","Fluoxetine","Selective serotonin reuptake inhibitor"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE2"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"QUADRUPLE","whoMasked":["PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR"]}},"enrollmentInfo":{"count":17,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"Fluoxetine","type":"EXPERIMENTAL","description":"20 mg fluoxetine capsule by mouth once daily for 90 days","interventionNames":["Drug: Fluoxetine"]},{"label":"Placebo","type":"PLACEBO_COMPARATOR","description":"Matching placebo","interventionNames":["Drug: Placebo"]}],"interventions":[{"type":"DRUG","name":"Fluoxetine","armGroupLabels":["Fluoxetine"],"otherNames":["Prozac","Sarafem"]},{"type":"DRUG","name":"Placebo","armGroupLabels":["Placebo"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Percent Change in the Bionocularly Averaged Perimetric Mean Deviation","description":"24-2 Humphrey perimetry was completed for each eye (Zeiss HFAIIi, Swedish Interactive Threshold Algorithm (SITA) Standard, size III white target, fixation enforced, corrected for near vision). 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Natural history of homonymous hemianopia. Neurology. 2006 Mar 28;66(6):901-5. doi: 10.1212/01.wnl.0000203338.54323.22."},{"pmid":"36166771","type":"DERIVED","citation":"Schneider CL, Prentiss EK, Busza A, Williams ZR, Mahon BZ, Sahin B. FLUORESCE: A Pilot Randomized Clinical Trial of Fluoxetine for Vision Recovery After Acute Ischemic Stroke. J Neuroophthalmol. 2023 Jun 1;43(2):237-242. doi: 10.1097/WNO.0000000000001654. Epub 2022 Jul 8."},{"pmid":"33230035","type":"DERIVED","citation":"Saionz EL, Feldon SE, Huxlin KR. Rehabilitation of cortically induced visual field loss. Curr Opin Neurol. 2021 Feb 1;34(1):67-74. doi: 10.1097/WCO.0000000000000884."}]}},"resultsSection":{"participantFlowModule":{"preAssignmentDetails":"5 participants were consented but 1 screen failed and 4 withdrew from the study before being randomized to an arm, received the intervention and before any data was collected.","groups":[{"id":"FG000","title":"Fluoxetine","description":"20 mg fluoxetine capsule by mouth once daily for 90 days\n\nFluoxetine"},{"id":"FG001","title":"Placebo","description":"Matching placebo\n\nPlacebo"}],"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"7"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"5"},{"groupId":"FG001","numSubjects":"6"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"1"}]}],"dropWithdraws":[{"type":"Withdrawal by 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