Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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
Locations
United States
Florida
University of Florida
RECRUITING
Gainesville
Contact Information
Primary
Jennifer Hagen, MD
hagenje@ortho.ufl.edu
352-273-7016
Backup
MaryBeth Horodyski, EdD
horodmb@ortho.ufl.edu
352-273-7074
Time Frame
Start Date:2024-03-01
Estimated Completion Date:2027-11-30
Participants
Target number of participants:200
Treatments
Experimental: Subjects randomized to get Fluoxetine therapy
Subjects will be randomized to take Fluoxetine (10mg by mouth per day for first 14 days then 20 mg by mouth for 9 months). The randomized drug will be prescribed by the study team on the day of randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy at the 2 week, 3 month, and 6 month follow-up visits
Active_comparator: Subjects randomized to Placebo
When a patient is enrolled, the inpatient research pharmacy will dispense the appropriately randomized medication in a visually similar, over-encapsulated form as Fluoxetine