100 Participants Needed

Duloxetine for Depression after Broken Bones

(SNRI Trial)

EG
Overseen ByErica Grochowski, MPH
Age: 65+
Sex: Any
Trial Phase: Phase 4
Sponsor: Wake Forest University Health Sciences
Must be taking: SNRIs
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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?

Duloxetine is effective in treating major depressive disorder and has shown significant effects on reducing pain in conditions like diabetic peripheral neuropathic pain and fibromyalgia, suggesting it may help with both depression and pain after broken bones.12345

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 B. Seymour, PhD, MS | Wake ...

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

I am 65 years old or older.
I had surgery for a fragile bone fracture in my leg.

Exclusion Criteria

Polytrauma
I have had a fracture caused by a disease.
Patients on hospice
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Treatment

Participants start on Duloxetine 30mg daily at time of discharge and report medication compliance monthly

12 months
Monthly check-ins (virtual or in-person)

Follow-up

Participants complete patient-reported outcome measures at 3 months, 6 months, and 1 year

12 months
3 visits (in-person or virtual)

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
Trial OverviewThe study tests whether prescribing Duloxetine 30 mg daily upon discharge is feasible for these patients. It will also assess depressive symptoms over time using the Geriatric Depression Scale and track medication compliance with monthly re-screening.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Duloxetine 30mgExperimental Treatment1 Intervention
Duloxetine 30mg daily 90 day supply and 3 refills

Duloxetine is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Cymbalta for:
  • Major Depressive Disorder
  • Generalized Anxiety Disorder
  • Fibromyalgia
  • Neuropathic Pain
  • Chronic Musculoskeletal Pain
🇪🇺
Approved in European Union as Cymbalta / Yentreve for:
  • Major Depressive Disorder
  • Generalized Anxiety Disorder
  • Diabetic Peripheral Neuropathic Pain
  • Fibromyalgia
  • Stress Urinary Incontinence
🇨🇦
Approved in Canada as Cymbalta for:
  • 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

Trials
1,432
Recruited
2,506,000+

Findings from Research

Duloxetine is an effective treatment for major depressive disorder (MDD), showing significant improvements in both emotional and painful physical symptoms, with noticeable effects after just 1-2 weeks at a dosage of 60 mg per day.
In terms of efficacy, duloxetine is comparable to other antidepressants like paroxetine and escitalopram over both short-term (up to 15 weeks) and longer-term (6-8 months) treatments, and it is generally well tolerated, although starting at 60 mg/day may lead to higher discontinuation rates due to side effects.
Duloxetine: a review of its use in the treatment of major depressive disorder.Frampton, JE., Plosker, GL.[2018]
In a 6-week clinical trial involving 148 children and adolescents with major depressive disorder, duloxetine did not demonstrate significant efficacy compared to placebo, with similar changes in depression scores between the two groups.
The safety profile of duloxetine was consistent with previous findings, showing a higher incidence of treatment-emergent adverse events (TEAEs) in the duloxetine group (78.7%) compared to placebo (62.2%), although most were mild or moderate in severity.
Efficacy and Safety of Duloxetine in Children and Adolescents with Major Depressive Disorder in Japan: A Randomized Double-Blind Placebo-Controlled Clinical Trial Followed by an Open-Label Long-Term Extension Trial.Saito, T., Ishida, M., Nishiyori, A., et al.[2022]
In a post-hoc analysis of six trials involving duloxetine for major depressive disorder, significant pain relief was observed within 2 weeks, which occurred faster than the onset of antidepressant effects as measured by the HAMD(17) scale.
The study found that the analgesic effect of duloxetine operates independently from its antidepressant effect, suggesting that the two mechanisms do not influence each other in terms of response time.
The relationship between antidepressant and analgesic responses: findings from six placebo-controlled trials assessing the efficacy of duloxetine in patients with major depressive disorder.Fishbain, DA., Detke, MJ., Wernicke, J., et al.[2019]

References

Duloxetine: a review of its use in the treatment of major depressive disorder. [2018]
Efficacy and Safety of Duloxetine in Children and Adolescents with Major Depressive Disorder in Japan: A Randomized Double-Blind Placebo-Controlled Clinical Trial Followed by an Open-Label Long-Term Extension Trial. [2022]
The relationship between antidepressant and analgesic responses: findings from six placebo-controlled trials assessing the efficacy of duloxetine in patients with major depressive disorder. [2019]
Does Screening for Depressive Symptoms Help Optimize Duloxetine Use in Knee Osteoarthritis Patients With Moderate Pain? A Cost-Effectiveness Analysis. [2023]
Efficacy of duloxetine in painful symptoms: an analgesic or antidepressant effect? [2015]
Acute massive pulmonary thromboembolism due to acute intoxication by duloxetine: a case report. [2015]
Long-term tolerability and effectiveness of duloxetine in the treatment of major depressive disorder. [2015]
Once-daily duloxetine 60 mg in the treatment of major depressive disorder: multicenter, double-blind, randomized, paroxetine-controlled, non-inferiority trial in China, Korea, Taiwan and Brazil. [2022]
Duloxetine: a review of its use in the management of major depressive disorder in older adults. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Duloxetine and Subacute Pain after Knee Arthroplasty when Added to a Multimodal Analgesic Regimen: A Randomized, Placebo-controlled, Triple-blinded Trial. [2018]