Fluoxetine for Post-Traumatic Mental Health in Musculoskeletal Injuries

Recruiting in Palo Alto (17 mi)

Overseen byJennifer Hagen, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Florida

No Placebo Group

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

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.

Eligibility Criteria

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

I am 18 or older with a fracture needing surgery, under UF Orthopedic Trauma care.

Exclusion Criteria

patients unlikely to follow up (live in at a distance from Gainesville, incarcerated etc.) will also be excluded.

I do not have a traumatic brain injury or a managed mental health condition.

Participant Groups

The study tests if Fluoxetine (an antidepressant) and Calcium can help improve mental health in patients recovering from musculoskeletal injuries. The goal is to find a treatment that surgical teams can manage without specialized mental health providers.

2Treatment groups

Experimental Treatment

Active Control

Group I: Subjects randomized to get Fluoxetine therapyExperimental Treatment1 Intervention

Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.

Group II: Subjects randomized to get Calcium SupplmentationActive Control1 Intervention

Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.

Fluoxetine is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Prozac for: