Duloxetine for Depression after Broken Bones
(SNRI Trial)
Trial Summary
What is the purpose of 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
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are already taking SSRIs, SNRIs, or mood stabilizers.
What evidence supports the effectiveness of the drug duloxetine for depression after broken bones?
Is duloxetine generally safe for humans?
Duloxetine, also known as Cymbalta, has been studied for various conditions and is generally considered safe for humans when used as prescribed. Common side effects include nausea, dry mouth, fatigue, insomnia, and dizziness, but serious issues can occur with overdose. Long-term studies show that most side effects are mild to moderate, and no new safety concerns have been identified.12678
How does the drug duloxetine differ from other treatments for depression after broken bones?
Duloxetine is unique because it not only treats depression but also has a direct effect on reducing pain, which can be beneficial for patients experiencing both depression and pain after broken bones. This dual action makes it different from other treatments that may only address depression or pain separately.135910
Research Team
Rachel Seymour, PhD
Principal Investigator
Wake Forest University Health Sciences
Eligibility Criteria
This trial is for individuals aged 50 and older who have had a lower extremity fragility fracture (a broken bone from a fall at standing height or less) and are managed operatively. It's designed to see if starting an antidepressant, Duloxetine, when they leave the hospital can help prevent depression.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants start on Duloxetine 30mg daily at time of discharge and report medication compliance monthly
Follow-up
Participants complete patient-reported outcome measures at 3 months, 6 months, and 1 year
Referral and Evaluation
Participants receive a referral to behavioral health, primary care, or psychiatrist for evaluation if they screen positive at any timepoint
Treatment Details
Interventions
- Duloxetine
Duloxetine is already approved in United States, European Union, Canada for the following indications:
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Diabetic Peripheral Neuropathic Pain
- Fibromyalgia
- Stress Urinary Incontinence
- Major Depressive Disorder
- Generalized Anxiety Disorder
- Fibromyalgia
- Neuropathic Pain
- Chronic Musculoskeletal Pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
Wake Forest University Health Sciences
Lead Sponsor