Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma

Completed · Phase 2

Conditions studied: Musculoskeletal Injury

In brief

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.

Key facts

Study ID

NCT04850222

Run by

University of Florida

People needed

55

Starts

2021-09-01

Expected to finish

2025-02-17

Last updated by the study team

2026-05-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of Florida — Gainesville, Florida, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.