NCT06046859 · University of Florida
Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
What this study is about
With this forward-looking 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.
View original scientific description
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.
Interventions
DRUG
Fluoxetine
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
DRUG
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
Primary outcome measures
Beck Dression Inventory survey, in the post injury period for patients with musculoskeletal trauma.
Time frame: Baseline up to 12 months
BDI-II Beck Depression Inventory: higher score means worse outcome; 0-63.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- Gainesville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations