Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
University of Florida
200 participants
Mar 1, 2024
INTERVENTIONAL
Summary
With this prospective double-blinded, placebo controlled clinical trial we hypothesize that immediate (post-injury) intervention with Fluoxetine will prevent/mitigate 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.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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)
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Interventions
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06046859