Fluoxetine for Post-Traumatic Mental Health in Musculoskeletal Injuries
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial does not specify whether you need to stop taking your current medications. However, if you have a history of certain mental health conditions and are on medication for them, you may be excluded from participating.
Is fluoxetine generally safe for humans?
How is the drug fluoxetine unique in treating post-traumatic mental health issues in musculoskeletal injuries?
Fluoxetine, commonly known as Prozac, is unique because it is a selective serotonin reuptake inhibitor (SSRI) that is primarily used to treat depression and anxiety disorders, but it is being explored for its potential to help with post-traumatic mental health issues in musculoskeletal injuries. This is novel as there are no standard treatments specifically for this condition, and fluoxetine's ability to improve mood and reduce stress may aid in recovery.46789
What data supports the effectiveness of the drug fluoxetine for post-traumatic mental health in musculoskeletal injuries?
Who Is on the Research Team?
Jennifer Hagen, MD
Principal Investigator
University of Florida
Are You a Good Fit for This Trial?
This trial is for adults over 18 with musculoskeletal trauma needing surgery, under the care of UF Orthopedic Trauma Division. It's not for those with traumatic brain injury, bipolar disorder or other managed mental health conditions, or who live too far from Gainesville to follow up.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Fluoxetine or Calcium supplementation during hospitalization and continue post-discharge
Follow-up
Participants are monitored for safety, mental well-being, and post-operative complications
What Are the Treatments Tested in This Trial?
Interventions
- Fluoxetine
Fluoxetine is already approved in United States, European Union for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Florida
Lead Sponsor