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NCT06046859 · ClinicalTrials.gov registry record · Phase 4
Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?
A Phase 4 study of Musculoskeletal Injury, sponsored by University of Florida.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 200
- Enrollment target
- 1
- Study location
NCT06046859: Recruiting Phase 4 study of Musculoskeletal Injury, sponsored by University of Florida.
NCT06046859 is a Phase 4 study of Musculoskeletal Injury that is actively recruiting participants, run by University of Florida. The registered enrollment target is 200 participants, below the 508-participant average among 15 other Musculoskeletal Injury trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06046859, a Phase 4 study of Musculoskeletal Injury, is actively recruiting participants, sponsored by University of Florida.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 200 participants
- Enrollment target
- 1
- Study location
Study Summary
With this prospective double-blinded, placebo controlled clinical trial we hypothesize that immediate (post-injury) intervention with Fluoxetine will prevent/mitigate the development of negative psychiatric symptomology such as PTSD and depression for victims of bodily trauma. We also hypothesize that immediate use of Fluoxetine will decrease subjects' pain, pain interference and opioid use without changing our standard of care post-injury pain medication regimen. Enrolled subjects will be randomized to Fluoxetine or placebo at their index hospitalization.
Primary Outcome
BDI-II Beck Depression Inventory: higher score means worse outcome; 0-63.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Fluoxetine
Study Locations (1)
Florida
- University of Florida - Gainesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2027-11-30 |
| Phase | Phase 4 |
What NCT06046859 shows while recruiting
NCT06046859 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 508-participant average among 15 other Musculoskeletal Injury trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Musculoskeletal Injury appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06046859 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT06046859 about?
NCT06046859 is a clinical study titled "Can Immediate Post-injury Fluoxetine Improve the Recovery Trajectories of Victims in Bodily Trauma?". With this prospective double-blinded, placebo controlled clinical trial we hypothesize that immediate (post-injury) intervention with Fluoxetine will prevent/mitigate the development of negative psychiatric symptomology such as PTSD and depression for victims of bodily trauma. We also hypothesize th...
What is the current status of trial NCT06046859?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2024-03-01. Estimated completion is 2027-11-30.
What conditions does trial NCT06046859 study?
This clinical trial studies the following conditions: Musculoskeletal Injury.
What interventions are being tested in trial NCT06046859?
The interventions under investigation include: Placebo (DRUG), Fluoxetine (DRUG).
Who is sponsoring clinical trial NCT06046859?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06046859 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06046859's enrollment target sits among peer trials
200 4th of 15 higher than 12 of 15 other Musculoskeletal Injury trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Musculoskeletal Injury trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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