Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Frac… (NCT05851898) | Clinical Trial Compass
RecruitingPhase 4
Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures
United States100 participantsStarted 2024-04-08
Plain-language 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
Who can participate
Age range
65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.