[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06046859":3,"trial-entities:NCT06046859":97,"trial-summary:NCT06046859":100},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":39,"secondary_outcomes":44,"sex":48,"minimum_age":49,"maximum_age":50,"healthy_volunteers":14,"eligibility_criteria":51,"std_ages":67,"locations":70,"central_contacts":83,"overall_officials":92,"references":95,"see_also_links":96},"NCT06046859","IRB202301506","Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?","RECRUITING","2027-03-17","2026-04","2026-04-13","2024-03-01","University of Florida","OTHER",false,"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.","Upwards of 40-85% survivors of bodily trauma (in the civilian world most commonly motor vehicle accidents, falls and assaults), develop moderate to severe negative psychiatric symptomology following their injuries. (2,7) This symptomology can persist for years; at least 20% of patients with musculoskeletal trauma, specifically, display symptomology consistent with post-traumatic stress disorder (PTSD) symptomology up to three years following their injury. (8) Poor mental health outcomes are an independent risk factor for poor physical and social outcomes. (9,10) These symptoms, which are highly impairing, are complicated and heightened by loss of work\u002Fincome following trauma, limited financial and social resources, and a large percentage of the population being uninsured\u002Funderinsured. Research has demonstrated that the pressures of poverty and low socioeconomic status alone predispose to PTSD symptomology and poor coping mechanisms, and this is compounded by decreased ability to obtain and pay for mental health care by those impoverished. There are significant barriers to mental health care for many adults, and these hurdles are even more insurmountable for those under or uninsured, minorities, and those in rural communities. (11) Very few victims of trauma who screen positive for psychological disorder receive mental health services following injury (12% at 3-months from injury), and if so, it is far removed from the injury (22% at 24-months from injury).",[18],"Musculoskeletal Injury",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE4",{"count":25,"type":26},200,"ESTIMATED",[28,34],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","Fluoxetine","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",[33],"Subjects randomized to get Fluoxetine therapy",{"type":29,"name":35,"description":36,"armGroupLabels":37},"Placebo","When a patient is enrolled, the inpatient research pharmacy will dispense the appropriately randomized medication in a visually similar, over-encapsulated form as Fluoxetine",[38],"Subjects randomized to Placebo",[40],{"measure":41,"description":42,"timeFrame":43},"Beck Dression Inventory survey, in the post injury period for patients with musculoskeletal trauma.","BDI-II Beck Depression Inventory: higher score means worse outcome; 0-63.","Baseline up to 12 months",[45],{"measure":46,"description":47,"timeFrame":43},"Patient reported pain scores, PROMIS Pain Interference, will be recorded at each visit.","PROMIS PI: Pain Interference; A score of 50 is average; Adaptive so no minimum\u002Fmaximum values.","ALL","18 Years","85 Years",{"inclusion":52,"exclusion":58,"raw_text":66},[53,54,55,56,57],"Admitted to UF Health for trauma resulting in:","One or more extremity fractures requiring surgery","Pelvic Fracture","Chest\u002Fabdominal Injury requiring intervention in operating room","Polytrauma (multiple organ systems\u002Fmultiple fractures) or Beck Depression Inventory (BDI-II) ≥ 14",[59,60,61,62,63,64,65],"Severe Traumatic Brain Injury or cognitively not able to participate in surveys. (Glasgow Coma Scale 3-8)","Other psychiatric conditions on current medical management (SSRI)","Incarceration or Pregnancy","Expected Injury Survival of less than 90 days","Medical or physical condition in opinion of investigators that would preclude safe study participation","Unable to provide informed consent due to language or other barriers","Current or previous substance abuse (excluding cannabinoids and alcohol)","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)",[68,69],"ADULT","OLDER_ADULT",[71],{"facility":12,"status":7,"city":72,"state":73,"zip":74,"country":75,"contacts":76,"geoPoint":80},"Gainesville","Florida","32608","United States",[77],{"name":78,"role":79},"Jennifer Hagen, MD","PRINCIPAL_INVESTIGATOR",{"lat":81,"lon":82},29.65163,-82.32483,[84,88],{"name":78,"role":85,"phone":86,"email":87},"CONTACT","352-273-7016","hagenje@ortho.ufl.edu",{"name":89,"role":85,"phone":90,"email":91},"MaryBeth Horodyski, EdD","352-273-7074","horodmb@ortho.ufl.edu",[93],{"name":94,"affiliation":12,"role":79},"Jennifer Hagan, MD",[],[],{"nct_id":4,"conditions":98,"biomarkers":99},[18],[],{"nct_id":4,"found":101,"summary":102,"prompt_version":112},true,{"design":103,"status":104,"heading":105,"summary":106,"follow_up":107,"word_count":108,"commitments":109,"compensation":110,"drugs_mentioned":111},"This is a double-blinded, placebo-controlled study, meaning neither you nor your doctors will know if you are receiving Fluoxetine or a placebo (an inactive substance). About 200 people are expected to participate.","completed","Fluoxetine for Recovery After Bodily Trauma","This study is looking at whether taking Fluoxetine (an antidepressant) right after a serious injury can help prevent or lessen mental health problems like PTSD (Post-Traumatic Stress Disorder) and depression. It also aims to see if Fluoxetine can reduce pain, how much pain interferes with daily life, and the need for opioid pain medication. You might be able to join if you are 18 to 85 years old and have been admitted to UF Health for a serious injury like a broken bone needing surgery, a pelvic fracture, or a chest\u002Fabdominal injury needing surgery. You also need to have multiple injuries or a certain score on a depression survey. The study is currently unclear about its recruitment status and plans to enroll 200 people. Success will be measured by changes in depression scores over 12 months.","Your depression levels will be measured from when you start the study up to 12 months later.",136,"You would take either Fluoxetine (10mg daily for 14 days, then 20mg daily for 9 months) or a placebo by mouth. The study team will monitor you for side effects.","Not stated in the trial record.",[30],"v2"]