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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 is a Phase 2 study that has completed, run by University of Florida. The registered enrollment target is 55 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04850222
The ClinicalTrials.gov registry entry for NCT04850222 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Florida, which has 1,106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Fluoxetine is the first listed.
NCT04850222 reports 0 study locations.
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.
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