Status:
RECRUITING
Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
Lead Sponsor:
University of Florida
Conditions:
Musculoskeletal Injury
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
Brief 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 psych...
Detailed Description
Upwards of 40-85% survivors of bodily trauma (in the civilian world most commonly motor vehicle accidents, falls and assaults), develop moderate to severe negative psychiatric symptomology following t...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06046859
Start Date
March 1 2024
End Date
November 30 2027
Last Update
March 26 2025
Active Locations (1)
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1
University of Florida
Gainesville, Florida, United States, 32608