Fluoxetine Mitigation Mental Health Study for Patients With Musculoskeletal Trauma

NCT04850222 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: IRB202100808OCR40926
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Musculoskeletal Injury

Outcome Measures

Primary Outcomes (5)

• BDI-II - Beck Depression Inventory-II

  Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of depressive symptoms.

  Baseline, 2 weeks, 6 weeks,3 months, 6 months, 1 year

• BAI - Beck Anxiety Inventory

  Score range 0-63. Higher scores indicate worse outcomes, reflecting greater severity of anxiety symptoms.

  Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year

• PSQI - Pittsburgh Sleep Quality Index

  Score range 0-21. Higher scores indicate worse outcomes, representing poorer sleep quality.

  2 weeks, 6 weeks, 3 months

• PSS-SR5 - PTSD Symptom Scale-Self-Report for DSM-5

  Score range 0-80. Higher scores indicate worse outcomes, representing greater PTSD symptom severity.

  Baseline, 2 weeks, 6 weeks, 6 months, 1 year

• PROMIS Social Isolation - Patient-Reported Outcomes Measurement Information System

  Scores are typically reported as T-scores, which generally range from about 20-80 (population mean = 50, standard deviation = 10). Higher scores indicate worse outcomes, meaning greater perceived social isolation, a higher PROMIS Social Isolation score reflects feeling more isolated, excluded, or disconnected from others, while lower scores indicate better social connectedness and less isolation.

  6 weeks, 3 months,6 months, 1 year

Secondary Outcomes (1)

• PEG - Pain, Enjoyment of Life, and General Activity Scale

  Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 1 year

Study Arms (2)

Subjects randomized to get Fluoxetine therapy

EXPERIMENTAL

Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day 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.

Drug: Fluoxetine

Subjects randomized to get Calcium Supplmentation

ACTIVE COMPARATOR

Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day 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.

Drug: Calcium

Interventions

Fluoxetine DRUG

Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day 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.

Subjects randomized to get Fluoxetine therapy

Calcium DRUG

Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day 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.

Subjects randomized to get Calcium Supplmentation

Eligibility Criteria

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

You may qualify if:

• patients 18 and older under the care of the UF Orthopedic Trauma Division admitted to UF Health for trauma resulting in one or more extremity or pelvic fractures requiring surgery will be screened.

You may not qualify if:

• patients with Traumatic Brain Injury or a past medical history of bipolar or other mental health conditions on current medical management will be excluded
• patients unlikely to follow up (live in at a distance from Gainesville, incarcerated etc.) will also be excluded.

Sponsors & Collaborators

• University of Florida: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32608, United States

Location

Related Publications (1)

• Lossada-Soto E, Pazik M, Horodyski MB, Vasilopoulos T, de Faria LB, Mathews C, Hagen J. Can fluoxetine mitigate mental health decline in musculoskeletal trauma patients: a pilot single-center randomized clinical trial. Pilot Feasibility Stud. 2022 Aug 17;8(1):184. doi: 10.1186/s40814-022-01119-8.

  PMID: 35978446 DERIVED

MeSH Terms

Interventions

Fluoxetine; Calcium

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Metals, Alkaline Earth; Elements; Inorganic Chemicals; Metals; Blood Coagulation Factors; Biological Factors

Results Point of Contact

• Title: Dr. Jennifer Hagen
• Organization: University of Florida

hagenje@ortho.ufl.edu

(352) 273-7013

Study Officials

• Jennifer Hagen, MD

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: April 14, 2021
• First Posted: April 20, 2021
• Study Start: September 1, 2021
• Primary Completion: February 17, 2025
• Study Completion: February 17, 2025
• Last Updated: April 14, 2026
• Results First Posted: April 14, 2026

Record last verified: 2025-08

Locations

US (1)