Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age65+
SponsorWake Forest University Health Sciences
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Geriatric (greater than or equal to 65 years old)
Lower extremity fragility fractures managed operatively
Disqualifiers
Polytrauma
Pathological fractures
Patients on hospice
Patients with previously diagnosed psychiatric disorders
Trial design
Design model
Single group
Treatments tested in this trial
Duloxetine 30 mg
DrugDuloxetine 30mg daily prescribed at discharge
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Duloxetine 30mgExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
up to 1 yearSecondary outcomes
1
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.
Time frame
Month 3, Month 6, and Year 12
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
Time frame
Month 3, Month 6, and Year 13
Number of patients who have side effects from the medication
Number of patients who have side effects from the medication
Time frame
Baseline, monthly up to 1 year4
Number of participants who undergo re-operation
Number of participants who undergo re-operation
Time frame
Baseline, monthly up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov