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

NCT05851898 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00095504
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Depression in Old Age; Fragility Fracture

Keywords

Geriatrics; Serotonin-norepinephrine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• PROMIS-29 Subscale Scores - Depression

  Month 3, Month 6, and Year 1

• PROMIS-29 Subscale Scores - Physical Function

  Month 3, Month 6, and Year 1

• Number of patients who have side effects from the medication

  Baseline, monthly up to 1 year

• Number of participants who undergo re-operation

  Baseline, monthly up to 1 year

• Number of participants who are readmitted to the hospital

  Baseline, monthly up to 1 year

Study Arms (1)

Duloxetine 30mg

EXPERIMENTAL

Duloxetine 30mg daily 90 day supply and 3 refills

Drug: Duloxetine 30 mg

Interventions

Duloxetine 30 mg DRUG

Duloxetine 30mg daily prescribed at discharge

Also known as: Common brands: Irenka, Cymbalta

Duloxetine 30mg

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Interventions

Duloxetine Hydrochloride

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Rachel Seymour, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Grochowski, MPH

CONTACT

704-403-4980; Erica.Grochowski@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: May 10, 2023
• Study Start: April 8, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)