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

StatusRecruiting
PhasePhase 4
Started2024-03-01
View on ClinicalTrials.gov ↗

Amendment history

2026-04-06
minor
Study Status v4
Primary completion date2027-11-30→2027-03-17
Completion date2027-11-30→2027-03-17
2025-03-25
minor
Study Status v3
Primary completion date2026-11-30→2027-11-30
Completion date2026-11-30→2027-11-30
2024-03-12
notable
Not Yet Recruiting→Recruiting Study Status, Study Design, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
PhaseEarly Phase 1→Phase 4
Study sitesdetails revised at 1 of 1 site
2024-02-14
minor
Study Status v1
Start date2023-11-01→2024-03-01
2023-09-18
minor
Original filing
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.
Trial Details
NCT Number NCT06046859
Lead Sponsor University of Florida
Conditions Musculoskeletal Injury
Enrollment 200 participants
Start Date 2024-03-01
Primary Completion 2027-03-17 (estimated)
Study Completion 2027-03-17 (estimated)
Updated on ClinicalTrials.gov 2026-04-13