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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
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 belowSelect...
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
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 • NCT002456358%
Weight Loss
8%
Stomach Pains
4%
Menstrual Cramps
4%
Silliness/Feeling too happy
4%
Trouble Sleeping
4%
Nausea
4%
Insomnia
4%
Nightmares
4%
Emotional
4%
Suicidal Behavior
4%
Lit Paper on Fire
4%
Fatigue
4%
Decreased Appetite
4%
Sweating
4%
Agitated/Restlessness
4%
Dry Mouth
4%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Fluoxetine
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
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.
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.
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Who is running the clinical trial?
University of FloridaLead Sponsor
1,385 Previous Clinical Trials
762,403 Total Patients Enrolled
1 Trials studying Musculoskeletal Injuries
150 Patients Enrolled for Musculoskeletal Injuries
Jennifer Hagan, MDPrincipal InvestigatorUniversity of Florida
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