What side effects are associated with this type of intervention?

Common treatments for musculoskeletal injuries, particularly SSRIs like Fluoxetine, can cause side effects such as nausea, headache, dizziness, insomnia, sexual dysfunction, and an increased risk of bone fractures. SSRIs may also lower the seizure threshold, which is important for patients with CNS diseases. Other similar treatments, such as SNRIs, may cause gastrointestinal issues and increased blood pressure.

What prior FDA approvals exist?

The FDA has approved several treatments for musculoskeletal injuries, including SSRIs like Fluoxetine, which is being studied for its potential to improve mood and reduce pain perception. Other related drugs include SNRIs such as duloxetine and venlafaxine, which have analgesic properties and are used to manage pain, including neuropathic pain. Tricyclic antidepressants (TCAs) like amitriptyline and nortriptyline are also used for their pain-relieving effects. These medications work by increasing levels of neurotransmitters in the brain, which can help improve mood and reduce the perception of pain.

What other types of research exist?

Promising alternatives to Fluoxetine for musculoskeletal injuries include Duloxetine and Venlafaxine, both of which are Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) that have shown efficacy in pain management and mood improvement. Additionally, Amitriptyline, a tricyclic antidepressant, has been effective in reducing pain and improving sleep, though it has a higher side effect profile. These alternatives have been supported by recent clinical trials and meta-analyses.

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Selective Serotonin Reuptake Inhibitor

Fluoxetine for Bodily Trauma Recovery

Phase 4

Recruiting

Led By Jennifer Hagan, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

One or more extremity fractures requiring surgery

Pelvic Fracture

Must not have

Other psychiatric conditions on current medical management (SSRI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 12 months

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests whether using Fluoxetine soon after an injury can prevent or reduce PTSD and depression in people who have been physically hurt. The medication works by boosting a 'feel-good' chemical in the brain to help improve mood and reduce anxiety. Fluoxetine is an antidepressant that has been shown to be effective in treating PTSD.

Who is the study for?

This trial is for trauma patients at UF Health with injuries like fractures needing surgery, pelvic or chest/abdominal injuries requiring OR intervention, polytrauma, or those feeling moderately depressed (BDI-II ≥ 14). It's not for those with severe brain injury, pregnant/in jail individuals, people who can't consent due to language/cognitive barriers, on SSRI treatment for other psychiatric conditions, unlikely to survive past 90 days or with a history of substance abuse.

What is being tested?

The study tests if Fluoxetine given right after bodily trauma can help prevent PTSD and depression. It also looks at whether it reduces pain and the need for opioids without changing usual pain treatments. Participants are randomly assigned to get either Fluoxetine or a placebo during their initial hospital stay.

What are the potential side effects?

Fluoxetine may cause side effects such as nausea, headaches, sleep disturbances, sexual dysfunction and increased risk of bleeding. Some might experience emotional changes like nervousness or mood swings.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I need surgery for one or more broken bones in my arms or legs.

Select...

I have had a pelvic fracture.

Select...

I needed surgery for a chest or abdominal injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently taking medication for a psychiatric condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Beck Dression Inventory survey, in the post injury period for patients with musculoskeletal trauma.

Secondary study objectives

Patient reported pain scores, PROMIS Pain Interference, will be recorded at each visit.

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635

Weight Loss

Stomach Pains

Silliness/Feeling too happy

Trouble Sleeping

Nausea

Menstrual Cramps

Insomnia

Nightmares

Emotional

Suicidal Behavior

Lit Paper on Fire

Fatigue

Decreased Appetite

Sweating

Agitated/Restlessness

Dry Mouth

Headache

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Fluoxetine

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

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 for first 14 days then 20 mg by mouth for 9 months). The randomized drug will be prescribed by the study team on the day of 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 at the 2 week, 3 month, and 6 month follow-up visits

Group II: Subjects randomized to PlaceboActive Control1 Intervention

When a patient is enrolled, the inpatient research pharmacy will dispense the appropriately randomized medication in a visually similar, over-encapsulated form as Fluoxetine

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fluoxetine

2005

Completed Phase 4

~2370

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Selective Serotonin Reuptake Inhibitors (SSRIs) like Fluoxetine work by increasing serotonin levels in the brain, which can improve mood and reduce pain perception. This is particularly important for musculoskeletal injury patients, as chronic pain often leads to depression and anxiety, further exacerbating pain. By improving mood and modulating pain pathways in the central nervous system, SSRIs can provide both psychological and physical relief, making them a valuable option in the comprehensive management of musculoskeletal injuries.

Does the Initiation of Fluoxetine Postacute Stroke Result in Improved Functional Recovery?: A Critically Appraised Topic.Fluoxetine and Fractures After Stroke: Exploratory Analyses From the FOCUS Trial.