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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Florida

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Fluoxetine
  • Placebo

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators