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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-85
SponsorUniversity of Florida

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Fluoxetine

    Drug

    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

  • Placebo

    Drug

    When 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

200 Participants
are divided into 2 treatment groups
Group A: Subjects randomized to get Fluoxetine therapyExperimental treatment 1 intervention
Group B: Subjects randomized to PlaceboActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline up to 12 months

Secondary outcomes

1

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.

Time frame
Baseline up to 12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.