What is Fluoxetine studying for musculoskeletal injury recovery?

Fluoxetine is being studied to see if starting it immediately after bodily trauma can reduce negative psychiatric symptoms like PTSD and depression. Researchers also want to find out if it can decrease pain and opioid use without changing standard pain care. The University of Florida is leading this clinical trial to improve recovery outcomes.

Who may be eligible for this musculoskeletal injury clinical trial?

Adults aged 18 to 85 who have experienced trauma resulting in certain fractures or chest/abdominal injury may be eligible. People with severe brain injury, current psychiatric medication management, pregnancy, incarceration, or substance abuse history may not qualify. This trial accepts all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this musculoskeletal injury clinical trial?

Study-related care, including the study drug or placebo and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and might not be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase 4

Age: 18Years - 85Years

All Genders

ID06046859

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

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.