Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Duloxetine 30 mg.
- Who it may be relevant to
- Registry conditions: Depression in Old Age, Fragility Fracture. Basic parameters: from 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients
Overview
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.
Interventions
- Drug Duloxetine 30 mg
Duloxetine 30mg daily prescribed at discharge
Primary outcome measures
- Geriatric Depression Scale (Short Form) Scores [Time frame: Baseline]
- Geriatric Depression Scale (Short Form) Scores [Time frame: up to 1 year]
Secondary outcome measures (7)
- PROMIS-29 Subscale Scores - Depression [Time frame: Month 3, Month 6, and Year 1]
- PROMIS-29 Subscale Scores - Physical Function [Time frame: Month 3, Month 6, and Year 1]
- Number of patients who have side effects from the medication [Time frame: Baseline, monthly up to 1 year]
- Number of participants who undergo re-operation [Time frame: Baseline, monthly up to 1 year]
- Number of participants who are readmitted to the hospital [Time frame: Baseline, monthly up to 1 year]
- Mortality Rate [Time frame: Baseline, monthly up to 1 year]
- Number of participants who re-fracture the study injury [Time frame: Baseline, monthly up to 1 year]
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.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- Wake Forest University Health Sciences — Winston-Salem
Identifiers
NCT: NCT05851898 · IRB00095504