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Could a common antidepressant stop mental health decline after a broken bone?

NCT ID NCT04850222

Symptom relief Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether giving fluoxetine (Prozac) to people with serious bone fractures could prevent or reduce depression, anxiety, and other mental health issues that often follow such injuries. 55 adults with broken bones requiring surgery were randomly assigned to take either fluoxetine or a calcium supplement for 90 days. The goal was to see if a simple medication, prescribed by the surgical team, could improve recovery beyond just physical healing.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
fluoxetine
What this could lead to
If it works, this could point toward a simple, safe way for surgeons to help patients avoid lasting mental health issues after a serious injury.
What could go wrong
This is a very small pilot study with only 55 people, so results may not apply widely. Fluoxetine can cause side effects like nausea or sleep problems, and it may not help everyone.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

55 people

The number who actually took part.

Started

Sep 2021

Finished

Feb 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

bone fracture injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Musculoskeletal injury

Contacts and locations

Locations

  • University of Florida

    Gainesville, Florida, 32608, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.