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

Depression in Old Age Clinical Trial

— SNRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05851898
• Other study ID #: IRB00095504
• Status: Recruiting
• Phase: Phase 4
• Start date: April 8, 2024
• Est. completion date: February 2025

Study information

• Verified date: April 2024
• Source: Wake Forest University Health Sciences
• Contact: Erica Grochowski, MPH
• Phone: 704-403-4980
• Email: Erica.Grochowski[@]atriumhealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.)

Related Conditions & MeSH terms

• Depression
• Depression in Old Age
• Depressive Disorder
• Fractures, Bone
• Fragility Fracture

Intervention

Drug:
• Duloxetine 30 mg
Duloxetine 30mg daily prescribed at discharge

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Number of participants who undergo re-operation	Number of participants who undergo re-operation	Baseline, monthly up to 1 year
Secondary	Number of participants who are readmitted to the hospital	Number of participants who are readmitted to the hospital	Baseline, monthly up to 1 year
Secondary	Mortality Rate	Mortality Rate	Baseline, monthly up to 1 year
Secondary	Number of participants who re-fracture the study injury	Number of participants who re-fracture	Baseline, monthly up to 1 year