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

Wake Forest University (WFU) logo

Wake Forest University (WFU)

Status and phase

Enrolling
Phase 4

Conditions

Depression in Old Age
Fragility Fracture

Treatments

Drug: Duloxetine 30 mg

Study type

Interventional

Funder types

Other

Identifiers

NCT05851898
IRB00095504

Details and patient eligibility

About

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

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Geriatric (greater than or equal to 65 years old)
  • Lower extremity fragility fractures managed operatively

Exclusion criteria

  • Polytrauma
  • Pathological fractures
  • Patients on hospice
  • Patients with previously diagnosed psychiatric disorders
  • Patients with previously diagnosed dementia
  • Patients already taking Selective serotonin reuptake inhibitors (SSRI)s and Serotonin- norepinephrine reuptake inhibitors (SNRI)s
  • Patients already taking mood stabilizing medication
  • Unable to provide informed consent (no use of a legal authorized representative)
  • Patients with pre-existing life limiting diagnoses (cancer, etc.)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

100 participants in 1 patient group

Duloxetine 30mg
Experimental group
Description:
Duloxetine 30mg daily 90 day supply and 3 refills
Treatment:
Drug: Duloxetine 30 mg

Trial contacts and locations

1

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Central trial contact

Erica Grochowski, MPH

Data sourced from clinicaltrials.gov

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