Actively Recruiting

Phase 4
Age: 18Years - 85Years
All Genders
NCT06046859

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

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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

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Florida

Gainesville, Florida, United States, 32608

Actively Recruiting

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