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

Launched by UNIVERSITY OF FLORIDA · Sep 18, 2023

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ClinConnect Summary

This clinical trial is studying whether giving a medication called Fluoxetine right after a serious injury can help patients recover better. Fluoxetine is known to help with mood and anxiety, and the researchers believe that taking it soon after a traumatic injury may reduce symptoms like depression and PTSD. They also hope it can help lessen pain and reduce the need for stronger pain medications without changing the usual pain treatment provided in the hospital.

To be eligible for this study, participants must be admitted to UF Health with serious injuries, such as fractures that require surgery or multiple injuries affecting different parts of the body. They should also have a certain level of depression as measured by a simple questionnaire. However, people with severe brain injuries, certain psychiatric conditions, or those who are pregnant cannot participate. If you join the study, you will be randomly assigned to receive either Fluoxetine or a placebo (a pill with no active ingredients) during your hospital stay. This trial is currently recruiting participants, and your involvement would contribute to understanding how immediate treatment can support recovery after traumatic injuries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• * 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 Criteria:
• • 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)