About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Fluoxetine
DrugSubjects 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
Placebo
DrugWhen a patient is enrolled, the inpatient research pharmacy will dispense the appropriately randomized medication in a visually similar, over-encapsulated form as Fluoxetine
Treatment groups
Trial outcomes
Primary outcomes
Beck Dression Inventory survey, in the post injury period for patients with musculoskeletal trauma.
BDI-II Beck Depression Inventory: higher score means worse outcome; 0-63.
Secondary outcomes
Patient reported pain scores, PROMIS Pain Interference, will be recorded at each visit.
PROMIS PI: Pain Interference; A score of 50 is average; Adaptive so no minimum/maximum values.
Sponsors and contacts
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