Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
Musculoskeletal Injury
About this trial
This is an interventional treatment trial for Musculoskeletal Injury
Eligibility Criteria
Inclusion Criteria: Admitted to UF Health for trauma resulting in: One or more extremity fractures requiring surgery Pelvic Fracture Chest/abdominal Injury requiring intervention in operating room Polytrauma (multiple organ systems/multiple fractures) or Beck Depression Inventory (BDI-II) ≥ 14 Exclusion Criteria: 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)
Sites / Locations
- University of Florida
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Subjects randomized to get Fluoxetine therapy
Subjects randomized to Placebo
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
When a patient is enrolled, the inpatient research pharmacy will dispense the appropriately randomized medication in a visually similar, over-encapsulated form as Fluoxetine