Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxi... | NCT05851898

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

NCT05851898

Sponsor

Wake Forest University Health Sciences

Status

Recruiting

Last Update Posted

Mar 12, 2026Actual

Enrollment

100Estimated

Phase

Phase 4

Conditions

Depression in Old Age
Fragility Fracture

Interventions

Duloxetine 30 mg

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2024Actual

Primary Completion Date

Dec 2028Estimated

Completion Date

Dec 2028Estimated

First Submitted Date

May 1, 2023

First Submission Date that Met QC Criteria

May 9, 2023

First Posted Date

May 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 11, 2026

Last Update Posted Date

Mar 12, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Duloxetine 30mg	Experimental	Duloxetine 30mg daily 90 day supply and 3 refills	Drug: Duloxetine 30 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Duloxetine 30 mg	Drug	Duloxetine 30mg daily prescribed at discharge	Duloxetine 30mg

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Erica Grochowski, MPH	Contact	704-403-4980		Erica.Grochowski@advocatehealth.org

Overall Officials

Name	Affiliation	Role
Rachel Seymour, PhD	Wake Forest University Health Sciences	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wake Forest University Health Sciences	Recruiting	Winston-Salem	North Carolina	27157	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068736	Duloxetine Hydrochloride

Ancestor Terms

ID	Term
D013876	Thiophenes
D013457	Sulfur Compounds
D009930	Organic Chemicals
D006573	Heterocyclic Compounds, 1-Ring

Browse Leaves

Not provided

Browse Branches

Not provided

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