NCT05851898

Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures

The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot study is to learn about the feasibility about prescribing anti-depressants at discharge in patients aged 50 years and older with a lower extremity fragility fracture. The main questions it aims to answer are: * What are the obstacles to enrolling patients and prescribing anti-depressants among older adults? * Is it possible to start prescribing SNRI medication upon discharge? * What is the prevalence of depressive symptoms amongst patients with different types of injuries and weightbearing status? * What is a transition of care plan for patients who have geriatric depression and require further care? Participants will: * Undergo screening using the Geriatric Depression Scale * Start on Duloxetine 30mg daily at time of discharge * Report medication compliance and complete re-screening monthly * Complete patient reported outcome measures and 3 months, 6 months, and 1 year * Receive a referral to behavioral health, primary care, or psychiatrist for evaluation if they screen positive at any timepoint

Detailed description

As with many mental health diagnoses, there continues to be a stigma against receiving treatment and potentially even more so receiving prophylaxis16. Identifying these hurdles at the patient level will allow us to better educate patients and physicians about the benefits of this intervention. Secondly, this pilot study will help us determine if it is possible to start prescribing SNRI medication upon discharge. It will allow us to navigate the procurement of medications through Medicare, prescribing practices at discharge and address patient concerns regarding starting a new medication.

Conditions

• Depression in Old Age
• Fragility Fracture

Interventions

Type	Name	Description
DRUG	Duloxetine 30 mg	Duloxetine 30mg daily prescribed at discharge

Timeline

• Start date: 2024-04-08
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2023-05-10
• Last updated: 2026-03-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study