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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to 12 months

Awards & highlights

Study Summary

This trial will investigate if Fluoxetine can prevent/mitigate PTSD & depression in trauma victims, and reduce pain & opioid use without changing meds. Subjects will be randomized to Fluoxetine/placebo.

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.Check my eligibility

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.See study design

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

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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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

Side effects data

From 2012 Phase 4 trial • 43 Patients • NCT00245635

Stomach Pains

Weight Loss

Nausea

Trouble Sleeping

Insomnia

Nightmares

Menstrual Cramps

Silliness/Feeling too happy

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

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,341 Previous Clinical Trials

715,446 Total Patients Enrolled

1 Trials studying Musculoskeletal Injuries

150 Patients Enrolled for Musculoskeletal Injuries

Jennifer Hagan, MDPrincipal InvestigatorUniversity of Florida

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research protocol open to individuals over 25 years of age?

"This clinical trial requires that all participants be aged between 18 and 85."

Answered by AI

For what type of individual is this medical experiment most suitable?

"This clinical study is searching for 200 individuals suffering from musculoskeletal injuries, ranging in age from 18 to 85. If you meet the criteria, you may be accepted into this trial."

Answered by AI

Are there any vacancies for this research trial?

"At the present time, this medical research is not seeking additional volunteers. As reported on clinicaltrials.gov, the trial was first posted November 1st 2023 and last updated September 18th of that same year. Although no longer recruiting patients, 794 other investigations are looking for participants currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?

2024. "Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06046859.

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