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Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?

Who can join

Ages 18 to 85 · All sexes

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)

About the study

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.

What is being tested

• Fluoxetine (drug)
• Placebo (drug)

Sponsor: University of Florida · Participants: 200 · Started: Mar 1, 2024

Contact the study team

• Jennifer Hagen, MD · Phone: 352-273-7016
• MaryBeth Horodyski, EdD · Phone: 352-273-7074

Official record on ClinicalTrials.gov — NCT06046859

Locations in the U.S.

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.