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

Primary Purpose

Depression in Old Age, Fragility Fracture

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Duloxetine 30 mg
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Depression in Old Age focused on measuring Geriatrics, Serotonin-norepinephrine

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine 30mg

Arm Description

Duloxetine 30mg daily 90 day supply and 3 refills

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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
Number of patients who have side effects from the medication
Number of patients who have side effects from the medication
Number of participants who undergo re-operation
Number of participants who undergo re-operation
Number of participants who are readmitted to the hospital
Number of participants who are readmitted to the hospital
Mortality Rate
Mortality Rate
Number of participants who re-fracture the study injury
Number of participants who re-fracture

Full Information

First Posted
May 1, 2023
Last Updated
August 29, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05851898
Brief Title
Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Old Age, Fragility Fracture
Keywords
Geriatrics, Serotonin-norepinephrine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine 30mg
Arm Type
Experimental
Arm Description
Duloxetine 30mg daily 90 day supply and 3 refills
Intervention Type
Drug
Intervention Name(s)
Duloxetine 30 mg
Other Intervention Name(s)
Common brands: Irenka, Cymbalta
Intervention Description
Duloxetine 30mg daily prescribed at discharge
Primary Outcome Measure Information:
Title
Geriatric Depression Scale (Short Form) Scores
Description
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.
Time Frame
Baseline
Title
Geriatric Depression Scale (Short Form) Scores
Description
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.
Time Frame
up to 1 year
Secondary Outcome Measure Information:
Title
PROMIS-29 Subscale Scores - Depression
Description
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.
Time Frame
Month 3, Month 6, and Year 1
Title
PROMIS-29 Subscale Scores - Physical Function
Description
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
Time Frame
Month 3, Month 6, and Year 1
Title
Number of patients who have side effects from the medication
Description
Number of patients who have side effects from the medication
Time Frame
Baseline, monthly up to 1 year
Title
Number of participants who undergo re-operation
Description
Number of participants who undergo re-operation
Time Frame
Baseline, monthly up to 1 year
Title
Number of participants who are readmitted to the hospital
Description
Number of participants who are readmitted to the hospital
Time Frame
Baseline, monthly up to 1 year
Title
Mortality Rate
Description
Mortality Rate
Time Frame
Baseline, monthly up to 1 year
Title
Number of participants who re-fracture the study injury
Description
Number of participants who re-fracture
Time Frame
Baseline, monthly up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Erica Grochowski, MPH
Phone
704-403-4980
Email
Erica.Grochowski@atriumhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rachel Seymour, PhD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica, MPH
Phone
704-403-4980
Email
Erica.Grochowski@atriumhealth.org
First Name & Middle Initial & Last Name & Degree
Rachel Seymour, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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