Actively Recruiting
Study of Immediate Fluoxetine Treatment After Bodily Trauma to Improve Recovery and Reduce Psychiatric Symptoms
Led by University of Florida · Updated on 2026-04-13
200
Participants Needed
1
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating whether giving Fluoxetine immediately after bodily trauma can help reduce negative psychiatric symptoms like PTSD and depression. This study focuses on adults who have suffered musculoskeletal injuries such as fractures or serious chest and abdominal injuries. The trial aims to see if early use of Fluoxetine can also lessen pain, reduce pain interference, and lower opioid use without altering the standard pain medication regimen. Participants will be randomly assigned to receive either Fluoxetine or a placebo. Those in the Fluoxetine group will take 10 mg daily by mouth for the first 14 days, then 20 mg daily for nine months. The medication will be prescribed during the hospital stay, with the first supply given at discharge and refills provided at follow-up visits at 2 weeks, 3 months, and 6 months. The placebo will look identical to Fluoxetine and be dispensed in the same manner. During the study, participants will complete surveys including the Beck Depression Inventory and report pain scores using PROMIS Pain Interference measures from baseline up to 12 months. The research team will monitor participants for side effects and track opioid use. Follow-up visits will help assess recovery, psychiatric symptoms, pain levels, and medication adherence throughout the year-long study period.
CONDITIONS
Brief Title
Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
Research Team
J
Jennifer Hagen, MD
M
MaryBeth Horodyski, EdD
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