RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-03-01
Study Completion:2026-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06046859

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Admitted to UF Health for trauma resulting in:
  2. * One or more extremity fractures requiring surgery
  3. * Pelvic Fracture
  4. * Chest/abdominal Injury requiring intervention in operating room
  5. * Polytrauma (multiple organ systems/multiple fractures) or Beck Depression Inventory (BDI-II) ≥ 14
  1. * Severe Traumatic Brain Injury or cognitively not able to participate in surveys. (Glasgow Coma Scale 3-8)
  2. * Other psychiatric conditions on current medical management (SSRI)
  3. * Incarceration or Pregnancy
  4. * Expected Injury Survival of less than 90 days
  5. * Medical or physical condition in opinion of investigators that would preclude safe study participation
  6. * Unable to provide informed consent due to language or other barriers
  7. * Current or previous substance abuse (excluding cannabinoids and alcohol)

Contacts and Locations

Study Contact

Jennifer Hagen, MD
CONTACT
352-273-7016
hagenje@ortho.ufl.edu
MaryBeth Horodyski, EdD
CONTACT
352-273-7074
horodmb@ortho.ufl.edu

Principal Investigator

Jennifer Hagan, MD
PRINCIPAL_INVESTIGATOR
University of Florida

Study Locations (Sites)

University of Florida
Gainesville, Florida, 32608
United States

Collaborators and Investigators

Sponsor: University of Florida

  • Jennifer Hagan, MD, PRINCIPAL_INVESTIGATOR, University of Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2026-11-30

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2026-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Musculoskeletal Injury