Phase 2
N=55
Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma
Musculoskeletal Injury
Bottom Line
View on ClinicalTrials.gov: NCT04850222 ↗Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Apr 2026
Primary outcome: Primary: BDI-II - Beck Depression Inventory-II — 11.4; 12.8; 9.6; 11.5 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluoxetine (Drug); Calcium (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BDI-II - Beck Depression Inventory-II |
11.4; 12.8; 9.6; 11.5; 8.1; 12.2 | — |
| PRIMARY BAI - Beck Anxiety Inventory |
12.7; 11.5; 9.9; 12.5; 10.5; 10.8 | — |
| PRIMARY PSQI - Pittsburgh Sleep Quality Index |
7; 9.4; 7.1; 7.3; 7.1; 6.6 | — |
| PRIMARY PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5 |
21.9; 15.1; 15.9; 19.3; 14.8; 17.3 | — |
| PRIMARY PROMIS Social Isolation - Patient-Reported Outcomes Measurement Information System |
43.7; 47.7; 45.9; 49; 50.8; 47.8 | — |
| SECONDARY PEG - Pain, Enjoyment of Life, and General Activity Scale |
5.7; 4.9; 5.3; 6.1; 3.9; 4.2 | — |
Summary
Musculoskeletal trauma is one of the leading causes of disability in the United States and its negative quality of life impact extends beyond that of physical recovery. More than 50% of victims of musculoskeletal trauma suffer lasting mental health issues following their injury. These symptoms can develop across all spectrums of patients with a variety of injury severities. Previously, this research team developed a ten-step program with the aim of developing fostering coping mechanisms in trauma patients. We were unable to demonstrate a measurable benefit to their mental health or physical function. This has been mirrored in other studies as well; talk therapy and support groups are not a strong enough intervention for some patients.
We hypothesize that a subset of the trauma population would benefit from medical treatment for their depressive and anxious symptoms in the early recovery period. Given the limited resources of mental health systems, it would be ideal for their surgical providers to be able to manage safely their post-injury mental health issues during their surgical follow up. This is a pragmatic pilot study to develop an effective, acceptable, time-limited treatment strategy that could be safely implemented by non-mental health care providers for victims of musculoskeletal trauma.
Eligibility Criteria
Inclusion Criteria
- patients 18 and older under the care of the UF Orthopedic Trauma Division admitted to UF Health for trauma resulting in one or more extremity or pelvic fractures requiring surgery will be screened.
Exclusion Criteria
- patients with Traumatic Brain Injury or a past medical history of bipolar or other mental health conditions on current medical management will be excluded
- patients unlikely to follow up (live in at a distance from Gainesville, incarcerated etc.) will also be excluded.
Data sourced from ClinicalTrials.gov (NCT04850222). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.