Actively Recruiting

Phase 4
Age: 65Years +
All Genders
ID05851898

The Role of SNRI's in Preventing Depression Following Lower Extremity Fragility Fractures in Older Adults

Led by Wake Forest University Health Sciences · Updated on 2026-03-12

100

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the feasibility of prescribing anti-depressants at discharge for patients aged 50 years and older who have experienced lower extremity fragility fractures. This pilot study aims to understand obstacles to enrolling patients and prescribing serotonin-norepinephrine reuptake inhibitors (SNRIs), assess the possibility of starting SNRI medication upon discharge, and investigate the prevalence of depressive symptoms among different injury types and weightbearing statuses. It also seeks to develop a transition of care plan for older patients with depression requiring further support. Participants will receive Duloxetine 30mg daily prescribed at discharge, with a 90-day supply plus three refills. They will be monitored over a year, with monthly reports on medication compliance and rescreening using the Geriatric Depression Scale. Referrals to behavioral health, primary care, or psychiatry will be given if depressive symptoms are detected. The study addresses medication procurement challenges and patient concerns related to starting new treatment after injury. During the study, participants will undergo initial and periodic depression screenings and complete patient-reported outcome measures at 3 months, 6 months, and 1 year. Researchers will monitor physical function, side effects, hospital readmissions, re-operations, mortality, and re-fractures. The study's primary measurements involve tracking Geriatric Depression Scale scores at baseline and up to one year. Participation spans at least one year from discharge, with ongoing assessments to understand the impact of early SNRI use in this population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 65 years or older
  • Have operatively managed lower extremity fragility fractures
Not Eligible

You will not qualify if you...

  • Polytrauma
  • Pathological fractures
  • Patients receiving hospice care
  • Previously diagnosed psychiatric disorders
  • Previously diagnosed dementia
  • Currently taking SSRIs or SNRIs
  • Currently taking mood stabilizing medication
  • Unable to provide informed consent without a legal representative
  • Pre-existing life-limiting illnesses such as cancer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 90 days with 3 refills

Participants receive Duloxetine 30mg daily prescribed at discharge to prevent depression following lower extremity fragility fractures.

Monthly visits for up to 3 months

Follow-up

Duration - Up to 1 year

Participants are monitored for depression symptoms, side effects, re-operations, hospital readmissions, mortality, and re-fractures for up to 1 year after starting treatment.

Monthly visits up to 1 year

Trial Site Locations

Total: 1 location

1

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

E

Erica Grochowski, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

PREVENTION

Number of Arms

1

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