[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100519692":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":33,"locations":43,"responsibleParty":59,"collaborators":25,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":25,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":25,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Subjects randomized to get Fluoxetine therapy","EXPERIMENTAL","Subjects will be randomized to take Fluoxetine (10mg by mouth per day for first 14 days then 20 mg by mouth for 9 months). The randomized drug will be prescribed by the study team on the day of randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy at the 2 week, 3 month, and 6 month follow-up visits",[13],"Drug: Fluoxetine",{"label":15,"type":16,"description":17,"interventionNames":18},"Subjects randomized to Placebo","ACTIVE_COMPARATOR","When a patient is enrolled, the inpatient research pharmacy will dispense the appropriately randomized medication in a visually similar, over-encapsulated form as Fluoxetine",[19],"Drug: Placebo",[21,26],{"type":22,"name":23,"description":11,"armGroupLabels":24,"otherNames":25},"DRUG","Fluoxetine",[9],null,{"type":22,"name":27,"description":17,"armGroupLabels":28,"otherNames":25},"Placebo",[15],[30],{"name":31,"affiliation":5,"role":32},"Jennifer Hagan, MD","PRINCIPAL_INVESTIGATOR",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":25,"email":38},"Jennifer Hagen, MD","CONTACT","352-273-7016","hagenje@ortho.ufl.edu",{"name":40,"role":36,"phone":41,"phoneExt":25,"email":42},"MaryBeth Horodyski, EdD","352-273-7074","horodmb@ortho.ufl.edu",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Gainesville","Florida","32608","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-82.32483,29.65163,{"lat":55,"lon":54},[58],{"name":35,"role":32,"phone":25,"phoneExt":25,"email":25},{"type":60,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100519692","phase-4-can-immediate-post-injury-fluoxetine-improve-the-recovery-trajectories-of-victims-in-bodily-trauma-100519692",false,"NCT06046859","Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?","Inclusion Criteria:\n\n* Admitted to UF Health for trauma resulting in:\n\n  * One or more extremity fractures requiring surgery\n  * Pelvic Fracture\n  * Chest\u002Fabdominal Injury requiring intervention in operating room\n* Polytrauma (multiple organ systems\u002Fmultiple fractures) or Beck Depression Inventory (BDI-II) ≥ 14\n\nExclusion Criteria:\n\n* Severe Traumatic Brain Injury or cognitively not able to participate in surveys. (Glasgow Coma Scale 3-8)\n* Other psychiatric conditions on current medical management (SSRI)\n* Incarceration or Pregnancy\n* Expected Injury Survival of less than 90 days\n* Medical or physical condition in opinion of investigators that would preclude safe study participation\n* Unable to provide informed consent due to language or other barriers\n* Current or previous substance abuse (excluding cannabinoids and alcohol)","ALL","18 Years","85 Years",{"count":71,"type":72},200,"ESTIMATED","INTERVENTIONAL",[75],"PHASE4","With this prospective double-blinded, placebo controlled clinical trial we hypothesize that immediate (post-injury) intervention with Fluoxetine will prevent\u002Fmitigate the development of negative psychiatric symptomology such as PTSD and depression for victims of bodily trauma. We also hypothesize that immediate use of Fluoxetine will decrease subjects' pain, pain interference and opioid use without changing our standard of care post-injury pain medication regimen. Enrolled subjects will be randomized to Fluoxetine or placebo at their index hospitalization.",[78],"Musculoskeletal Injury","2026-04-06",{"date":81,"type":82},"2026-04-13","ACTUAL",{"date":84,"type":82},"2024-03-01",{"date":86,"type":72},"2027-03-17",{"name":5,"class":6},1]