Recruiting

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

Sponsor:

University of Florida

Code:

NCT06046859

Conditions

Musculoskeletal Injury

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Fluoxetine

Placebo

Study Details

Brief summary:

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.

Conditions

Musculoskeletal Injury

Study ID

NCT06046859

Start date

Mar 1, 2024

Status verified date

Apr, 2026

Completion date

Mar 17, 2027

Anticipated

Primary completion date

Mar 17, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Subjects randomized to get Fluoxetine therapy

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

active comparator: Subjects randomized to 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

Interventions

Fluoxetine

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 measure

Beck Dression Inventory survey, in the post injury period for patients with musculoskeletal trauma. [ Time Frame: Baseline up to 12 months ]

Central Contacts and Locations

Central contacts

Jennifer Hagen, MD

352-273-7016 hagenje@ortho.ufl.edu

MaryBeth Horodyski, EdD

352-273-7074 horodmb@ortho.ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Principal Investigator:

Jennifer Hagen, MD

More Information

Sponsor

University of Florida

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-04-13.