A Phase 4 interventional study of Duloxetine 30 mg in Depression in Old Age and Fragility Fracture, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-03-12.
Sponsored by Wake Forest University Health Sciences · Phase 4, Interventional, and Prevention
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:
Participants will:
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.
Wake Forest University Health Sciences is the lead sponsor of 1,320 studies on the registry; 199 are open to participants now.
Of its 323 completed or terminated interventional studies of FDA-regulated products, 243 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Duloxetine 30mg daily 90 day supply and 3 refills
Drug: Duloxetine 30 mg
Duloxetine 30mg daily prescribed at discharge
Also known as: Common brands: Irenka, Cymbalta
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: 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.
Time frame: up to 1 year
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 1
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 1
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 year
Number of participants who undergo re-operation
Number of participants who undergo re-operation
Time frame: Baseline, monthly up to 1 year
Number of participants who are readmitted to the hospital
Number of participants who are readmitted to the hospital
Time frame: Baseline, monthly up to 1 year
Mortality Rate
Mortality Rate
Time frame: Baseline, monthly up to 1 year
Number of participants who re-fracture the study injury
Number of participants who re-fracture
Time frame: Baseline, monthly up to 1 year
Plan to share: No
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Wake Forest University Health Sciences