Fluoxetine for Recovery After Bodily Trauma

This study is looking at whether taking Fluoxetine (an antidepressant) right after a serious injury can help prevent or lessen mental health problems like PTSD (Post-Traumatic Stress Disorder) and depression. It also aims to see if Fluoxetine can reduce pain, how much pain interferes with daily life, and the need for opioid pain medication. You might be able to join if you are 18 to 85 years old and have been admitted to UF Health for a serious injury like a broken bone needing surgery, a pelvic fracture, or a chest/abdominal injury needing surgery. You also need to have multiple injuries or a certain score on a depression survey. The study is currently unclear about its recruitment status and plans to enroll 200 people. Success will be measured by changes in depression scores over 12 months.

Study design
This is a double-blinded, placebo-controlled study, meaning neither you nor your doctors will know if you are receiving Fluoxetine or a placebo (an inactive substance). About 200 people are expected to participate.
What's involved
You would take either Fluoxetine (10mg daily for 14 days, then 20mg daily for 9 months) or a placebo by mouth. The study team will monitor you for side effects.
Compensation
Not stated in the trial record.
Follow-up
Your depression levels will be measured from when you start the study up to 12 months later.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06046859

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

Recruiting
PHASE4Ages 18–85InterventionalTreatment
University of Florida
~200 participants
Updated 2026-04-13 on ClinicalTrials.gov
What's tested:FluoxetinePlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Beck Dression Inventory survey, in the post injury period for patients with musculoskeletal trauma.
Measured over Baseline up to 12 months
Musculoskeletal Injury

NCT06046859

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • University of Florida

    Gainesville, Floridano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Jennifer Hagan, MD · PRINCIPAL_INVESTIGATOR · University of Florida

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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)
  • Beck Dression Inventory survey, in the post injury period for patients with musculoskeletal trauma.Baseline up to 12 months

    BDI-II Beck Depression Inventory: higher score means worse outcome; 0-63.