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NCT Number: NCT05851898

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

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

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Key information

Conditions

Depression in Old Age Fragility Fracture

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location status: Recruiting

Location contact

Erica, MPH

CONTACT

[email protected]

704-403-4980

Rachel Seymour, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Duloxetine 30 MG

Drug

Duloxetine 30mg daily prescribed at discharge

Other names: Common brands: Irenka, Cymbalta

Primary outcomes

  1. Geriatric Depression Scale (Short Form) Scores

    Time frame: Baseline

    This 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.

  2. Geriatric Depression Scale (Short Form) Scores

    Time frame: up to 1 year

    This 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 outcomes

  1. PROMIS-29 Subscale Scores - Depression

    Time frame: Month 3, Month 6, and Year 1

    The 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.

  2. PROMIS-29 Subscale Scores - Physical Function

    Time frame: Month 3, Month 6, and Year 1

    The 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

  3. Number of patients who have side effects from the medication

    Time frame: Baseline, monthly up to 1 year

    Number of patients who have side effects from the medication

  4. Number of participants who undergo re-operation

    Time frame: Baseline, monthly up to 1 year

    Number of participants who undergo re-operation

  5. Number of participants who are readmitted to the hospital

    Time frame: Baseline, monthly up to 1 year

    Number of participants who are readmitted to the hospital

  6. Mortality Rate

    Time frame: Baseline, monthly up to 1 year

    Mortality Rate

  7. Number of participants who re-fracture the study injury

    Time frame: Baseline, monthly up to 1 year

    Number of participants who re-fracture

Study contacts

Contact information is provided by the study sponsor or research team.

Erica Grochowski, MPH

CONTACT

[email protected]

704-403-4980

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

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

Acronym: SNRI

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
May 10, 2023
Registry last updated
Mar 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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