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NCT04850222 · ClinicalTrials.gov registry record · Phase 2
Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma
A Phase 2 study, sponsored by University of Florida.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT04850222: Completed Phase 2 study, sponsored by University of Florida.
NCT04850222 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 55 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04850222, a Phase 2 study, has completed, sponsored by University of Florida.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
Musculoskeletal trauma is one of the leading causes of disability in the United States and its negative quality of life impact extends beyond that of physical recovery. More than 50% of victims of musculoskeletal trauma suffer lasting mental health issues following their injury. These symptoms can develop across all spectrums of patients with a variety of injury severities. Previously, this research team developed a ten-step program with the aim of developing fostering coping mechanisms in trauma patients. We were unable to demonstrate a measurable benefit to their mental health or physical function. This has been mirrored in other studies as well; talk therapy and support groups are not a strong enough intervention for some patients. We hypothesize that a subset of the trauma population would benefit from medical treatment for their depressive and anxious symptoms in the early recovery period. Given the limited resources of mental health systems, it would be ideal for their surgical providers to be able to manage safely their post-injury mental health issues during their surgical follow up. This is a pragmatic pilot study to develop an effective, acceptable, time-limited treatment strategy that could be safely implemented by non-mental health care providers for victims of musculoskeletal trauma.
Primary Outcome
Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of depressive symptoms.
Interventions
- DRUG Fluoxetine
- DRUG Calcium
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-09-01 |
| Est. Completion | 2025-02-17 |
| Phase | Phase 2 |
What the finished NCT04850222 record still lists
NCT04850222 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (59% lower).
The record links to 0 conditions, and to 2 interventions - of which Fluoxetine is the first listed.
NCT04850222 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04850222 about?
NCT04850222 is a clinical study titled "Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma". Musculoskeletal trauma is one of the leading causes of disability in the United States and its negative quality of life impact extends beyond that of physical recovery. More than 50% of victims of musculoskeletal trauma suffer lasting mental health issues following their injury. These symptoms can d...
What is the current status of trial NCT04850222?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2021-09-01. Estimated completion is 2025-02-17.
What interventions are being tested in trial NCT04850222?
The interventions under investigation include: Fluoxetine (DRUG), Calcium (DRUG).
Who is sponsoring clinical trial NCT04850222?
This trial is sponsored by University of Florida, which has 1,106 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04850222's enrollment target sits among peer trials
55 1153rd of 2000 higher than 841 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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