Actively Recruiting
Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
Led by University of Florida · Updated on 2026-04-13
200
Participants Needed
1
Research Sites
158 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults admitted to UF Health for trauma with one or more extremity fractures requiring surgery
- Adults admitted with pelvic fracture
- Adults admitted with chest or abdominal injury requiring surgery
- Adults with polytrauma (multiple organ systems or fractures) or Beck Depression Inventory score of 14 or higher
You will not qualify if you...
- Severe traumatic brain injury or unable to participate in surveys (Glasgow Coma Scale 3-8)
- Current psychiatric treatment with SSRIs
- Incarceration or pregnancy
- Expected survival less than 90 days due to injury
- Medical or physical conditions preventing safe study participation
- Unable to provide informed consent due to language or other barriers
- Current or previous substance abuse excluding cannabinoids and alcohol
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Florida
Gainesville, Florida, United States, 32608
Actively Recruiting
Research Team
J
Jennifer Hagen, MD
CONTACT
M
MaryBeth Horodyski, EdD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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