Using Fluoxetine right after injury to help trauma victims recover better
Official title: Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
Run by University of Florida · NCT06046859 · Data updated 2026-11-12
This study is testing if giving Fluoxetine right after an injury can help trauma victims avoid PTSD and depression while also looking at pain levels and opioid use.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | University of Florida Academic / other |
| Locations | 1 site (Gainesville, Florida) |
| Status | Recruiting |
| Started | March 1, 2024 |
| Main results expected | March 17, 2027 |
| Study ends | March 17, 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT06046859 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals admitted for trauma with specific injuries such as extremity fractures, pelvic fractures, or chest/abdominal injuries requiring surgical intervention.
✕Probably not a fit
Patients with severe traumatic brain injuries, current psychiatric conditions on SSRI treatment, or those unable to provide informed consent may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates whether administering Fluoxetine immediately after bodily trauma can reduce the risk of developing negative psychiatric symptoms such as PTSD and depression. The study employs a prospective double-blinded, placebo-controlled design, where participants will be randomly assigned to receive either Fluoxetine or a placebo during their hospitalization. The aim is to assess not only the psychological outcomes but also the impact on pain levels and opioid use, while maintaining standard post-injury pain management protocols.
Why it matters
Potential benefit: If successful, this approach could significantly improve mental health outcomes and reduce pain for trauma victims, potentially decreasing reliance on opioids.
How similar studies have gone: While the use of Fluoxetine in this immediate post-injury context is novel, previous studies have shown promise in using SSRIs for PTSD and depression in trauma patients.
Who can join: the full rules
Show full inclusion / exclusion 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)
Where it's running
-
University of Florida
Gainesville, Florida, United States Recruiting
Study contacts
- Principal investigator: Jennifer Hagan, MD — University of Florida
- Study coordinator: Jennifer Hagen, MD
- Email: hagenje@ortho.ufl.edu
- Phone: 352-273-7016
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.