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

NCT06046859 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB202301506
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Injury

Outcome Measures

Primary Outcomes (1)

• Beck Dression Inventory survey, in the post injury period for patients with musculoskeletal trauma.

  BDI-II Beck Depression Inventory: higher score means worse outcome; 0-63.

  Baseline up to 12 months

Secondary Outcomes (1)

• Patient reported pain scores, PROMIS Pain Interference, will be recorded at each visit.

  Baseline up to 12 months

Study Arms (2)

Subjects randomized to get Fluoxetine therapy

EXPERIMENTAL

Subjects will be randomized to take Fluoxetine (10mg by mouth per day for first 14 days then 20 mg by mouth for 9 months). The randomized drug will be prescribed by the study team on the day of randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy at the 2 week, 3 month, and 6 month follow-up visits

Drug: Fluoxetine

Subjects randomized to Placebo

ACTIVE COMPARATOR

When a patient is enrolled, the inpatient research pharmacy will dispense the appropriately randomized medication in a visually similar, over-encapsulated form as Fluoxetine

Drug: Placebo

Interventions

Fluoxetine DRUG

Subjects will be randomized to take Fluoxetine (10mg by mouth per day for first 14 days then 20 mg by mouth for 9 months). The randomized drug will be prescribed by the study team on the day of randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy at the 2 week, 3 month, and 6 month follow-up visits

Subjects randomized to get Fluoxetine therapy

Placebo DRUG

When a patient is enrolled, the inpatient research pharmacy will dispense the appropriately randomized medication in a visually similar, over-encapsulated form as Fluoxetine

Subjects randomized to Placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Admitted to UF Health for trauma resulting in:
• One or more extremity fractures requiring surgery
• Pelvic Fracture
• Chest/abdominal Injury requiring intervention in operating room
• Polytrauma (multiple organ systems/multiple fractures) or Beck Depression Inventory (BDI-II) ≥ 14

You may not qualify if:

• Severe Traumatic Brain Injury or cognitively not able to participate in surveys. (Glasgow Coma Scale 3-8)
• Other psychiatric conditions on current medical management (SSRI)
• Incarceration or Pregnancy
• Expected Injury Survival of less than 90 days
• Medical or physical condition in opinion of investigators that would preclude safe study participation
• Unable to provide informed consent due to language or other barriers
• Current or previous substance abuse (excluding cannabinoids and alcohol)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

RECRUITING

MeSH Terms

Interventions

Fluoxetine

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Jennifer Hagan, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer Hagen, MD

CONTACT

352-273-7016; hagenje@ortho.ufl.edu

MaryBeth Horodyski, EdD

CONTACT

352-273-7074; horodmb@ortho.ufl.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Researchers collecting survey data will be blinded to patients' intervention status.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2023
• First Posted: September 21, 2023
• Study Start: March 1, 2024
• Primary Completion (Estimated): March 17, 2027
• Study Completion (Estimated): March 17, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)