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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
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05851898
Acronym
SNRI
Enrollment
100
Registered
2023-05-10
Start date
2024-04-08
Completion date
2028-12-01
Last updated
2026-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression in Old Age, Fragility Fracture

Keywords

Geriatrics, Serotonin-norepinephrine

Brief 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.

Interventions

Duloxetine 30mg daily prescribed at discharge

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Intervention model description

geriatric patients with operative lower extremity fragility fractures that will be started on Serotonin-norepinephrine reuptake inhibitor (SNRI) medication immediately after obtaining consent at index hospitalization or first post operative clinic appointment

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Geriatric Depression Scale (Short Form) ScoresBaselineThis scale will be used as the primary outcome in this study as an indicator of patients who develop depression post-operatively. Scores range from 1-15. A score of 5 or greater indicates depression.

Secondary

MeasureTime frameDescription
PROMIS-29 Subscale Scores - DepressionMonth 3, Month 6, and Year 1The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means higher depression.
PROMIS-29 Subscale Scores - Physical FunctionMonth 3, Month 6, and Year 1The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Possible scores range from 0 to 100, with higher scores representing better health status
Number of patients who have side effects from the medicationBaseline, monthly up to 1 yearNumber of patients who have side effects from the medication
Number of participants who undergo re-operationBaseline, monthly up to 1 yearNumber of participants who undergo re-operation
Number of participants who are readmitted to the hospitalBaseline, monthly up to 1 yearNumber of participants who are readmitted to the hospital
Mortality RateBaseline, monthly up to 1 yearMortality Rate
Number of participants who re-fracture the study injuryBaseline, monthly up to 1 yearNumber of participants who re-fracture

Countries

United States

Contacts

CONTACTErica Grochowski, MPH
Erica.Grochowski@advocatehealth.org704-403-4980
PRINCIPAL_INVESTIGATORRachel Seymour, PhD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 13, 2026