Overview

Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma

Status:
Not yet recruiting
Trial end date:
2022-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Florida
Treatments:
Calcium
Fluoxetine
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.