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

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

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

Study Overview

• Status: Recruiting
• Conditions: Depression in Old Age; Fragility Fracture
• Intervention / Treatment: Drug: Duloxetine 30 mg

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Erica Grochowski, MPH; Phone Number: 704-403-4980; Email: Erica.Grochowski@atriumhealth.org

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Recruiting
      • Wake Forest University Health Sciences
      • Contact: Erica, MPH; Phone Number: 704-403-4980; Email: Erica.Grochowski@atriumhealth.org
      • Principal Investigator: Rachel Seymour, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duloxetine 30mg; Duloxetine 30mg daily 90 day supply and 3 refills	Drug: Duloxetine 30 mg; Duloxetine 30mg daily prescribed at discharge; Other Names: Common brands: Irenka, Cymbalta

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Geriatric Depression Scale (Short Form) Scores	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.	Baseline
Geriatric Depression Scale (Short Form) Scores	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.	up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-29 Subscale Scores - Depression	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.	Month 3, Month 6, and Year 1
PROMIS-29 Subscale Scores - Physical Function	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	Month 3, Month 6, and Year 1
Number of patients who have side effects from the medication	Number of patients who have side effects from the medication	Baseline, monthly up to 1 year
Number of participants who undergo re-operation	Number of participants who undergo re-operation	Baseline, monthly up to 1 year
Number of participants who are readmitted to the hospital	Number of participants who are readmitted to the hospital	Baseline, monthly up to 1 year
Mortality Rate	Mortality Rate	Baseline, monthly up to 1 year
Number of participants who re-fracture the study injury	Number of participants who re-fracture	Baseline, monthly up to 1 year

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Rachel Seymour, PhD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2025

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): April 23, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Geriatrics; Serotonin-norepinephrine
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Wounds and Injuries; Depression; Depressive Disorder; Fractures, Bone; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: IRB00095504

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No