Clinical Trial

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

Recruiting Phase 4
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-09-18; most recent amendment 2026-04-06.
Status change: Not Yet Recruiting → Recruiting 2024-03-12
Trial Details
NCT Number NCT06046859
Lead Sponsor University of Florida
Conditions Musculoskeletal Injury
Enrollment 200 participants
Start Date 2024-03-01
Primary Completion 2027-03-17 (estimated)
Study Completion 2027-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-13