Clincosm LogoSign in Get a demo

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

Sponsor
Wake Forest University Health Sciences (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05851898
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
18
Anticipated Duration (Months)
5.5
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Duloxetine 30 mg
 Phase 4

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
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 appointmentgeriatric 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)
Primary Purpose:
Prevention
Official Title:
The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Geriatric Depression Scale (Short Form) Scores [Baseline]

      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.

    2. Geriatric Depression Scale (Short Form) Scores [up to 1 year]

      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

    1. PROMIS-29 Subscale Scores - Depression [Month 3, Month 6, and Year 1]

      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.

    2. PROMIS-29 Subscale Scores - Physical Function [Month 3, Month 6, and Year 1]

      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

    3. Number of patients who have side effects from the medication [Baseline, monthly up to 1 year]

      Number of patients who have side effects from the medication

    4. Number of participants who undergo re-operation [Baseline, monthly up to 1 year]

      Number of participants who undergo re-operation

    5. Number of participants who are readmitted to the hospital [Baseline, monthly up to 1 year]

      Number of participants who are readmitted to the hospital

    6. Mortality Rate [Baseline, monthly up to 1 year]

      Mortality Rate

    7. Number of participants who re-fracture the study injury [Baseline, monthly up to 1 year]

      Number of participants who re-fracture

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Health Sciences Winston-Salem North Carolina United States 27157

    Sponsors and Collaborators

    • Wake Forest University Health Sciences

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Wake Forest University Health Sciences
    ClinicalTrials.gov Identifier:
    NCT05851898
    Other Study ID Numbers:
    • IRB00095504
    First Posted:
    May 10, 2023
    Last Update Posted:
    May 10, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Wake Forest University Health Sciences
    Geriatrics
    Serotonin-norepinephrine
    Additional relevant MeSH terms:
    Fractures, Bone
    Depression
    Depressive Disorder
    Duloxetine Hydrochloride

    Study Results

    No Results Posted as of May 10, 2023