drugset / Trial / NCT04850222

Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma

NCT04850222

Phase 2 Completed 55 enrolled University of Florida
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2021-09-01
Primary completion
2025-02-17
Completion
2025-02-17

Drugs

EvaluationDrugModalityDoseRoute
Comparator Calcium carbonate Other / unclassified 1000 mg Oral
Subject Fluoxetine Small molecule 10 mg Oral