100 Participants Needed

Antidepressants for Depression in Orthopaedic Trauma Patients

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Overseen ByErica Grochowski, MPH
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Wake Forest University Health Sciences
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

Trial Summary

Will I have to stop taking my current medications?

If you are currently taking medication to treat depression, you cannot participate in this trial.

What data supports the effectiveness of the drug duloxetine for depression in orthopedic trauma patients?

Duloxetine is effective in treating depression and has shown benefits in managing pain and improving quality of life in patients with knee osteoarthritis, which often co-occurs with depression. This suggests it may help orthopedic trauma patients who experience both pain and depression.12345

Is duloxetine generally safe for humans?

Duloxetine has been studied for various conditions, including depression and knee osteoarthritis, and is generally considered safe for humans. Some people may experience side effects like nausea, weight gain, or palpitations, but these are usually mild or moderate.12678

What makes the drug unique for depression in orthopedic trauma patients?

Duloxetine is unique because it is a dual reuptake inhibitor of serotonin and norepinephrine, which can provide more effective and faster antidepressant effects compared to other common medications. It is also used for a wide variety of conditions, including chronic musculoskeletal pain, which may be relevant for orthopedic trauma patients.1591011

What is the purpose of this trial?

The goal of this trial is to pilot a way for orthopaedic surgeons to safely screen for depression and provide treatment for depression with medication. The main questions it aims to answer are:1. What are the outcomes of patients who screen positive for depressive symptoms and are prescribed either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI).2. What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?

Research Team

MK

Meghan K Wally, PhD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for adults over 18 who speak English or Spanish, have had an orthopaedic trauma surgery, and show signs of depression but aren't currently on antidepressants or have bipolar/psychotic disorders. They must score at least a 5 on the PHQ-9 questionnaire.

Inclusion Criteria

I am seeing an orthopedic trauma specialist for the first time for a broken limb or pelvis.
A score of greater than or equal to 5 on the Patient Health Questionnaire-9 (PHQ-9) at first post-operative visit

Exclusion Criteria

I am currently on medication for depression.
Endorse suicidal ideation
Contraindication/allergy to one of the study medications
See 1 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person)

Treatment

Participants receive either an SSRI or SNRI medication or are referred to behavioral health resources

12 months
Monthly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months
Visits at months 3, 6, and 12

Treatment Details

Interventions

  • Duloxetine
  • Fluoxetine
  • Observation
Trial Overview The study tests if prescribing Fluoxetine (an SSRI) or Duloxetine (an SNRI), compared to no medication, helps with depression in patients after orthopaedic trauma surgery. It looks at patient outcomes based on these treatments.
Participant Groups
3Treatment groups
Experimental Treatment
Group I: serotonin and norepinephrine reuptake inhibitors (SNRI)Experimental Treatment1 Intervention
Duloxetine, 30mg once daily
Group II: Selective serotonin reuptake inhibitors (SSRI)Experimental Treatment1 Intervention
Fluoxetine, 20mg once daily
Group III: ObservationalExperimental Treatment1 Intervention
Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.

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

Adding duloxetine to the usual care for knee osteoarthritis (OA) patients with moderate pain is cost-effective, providing significant health benefits (31 additional quality-adjusted life years per 1,000 subjects) at a reasonable cost of $39,300 per quality-adjusted life year.
Implementing a depression screening strategy before prescribing duloxetine also proves beneficial, yielding 17 additional quality-adjusted life years per 1,000 subjects at a cost of $17,000 per quality-adjusted life year, making it a viable option for improving patient outcomes.
Does Screening for Depressive Symptoms Help Optimize Duloxetine Use in Knee Osteoarthritis Patients With Moderate Pain? A Cost-Effectiveness Analysis.Lenhard, NK., Sullivan, JK., Ross, EL., et al.[2023]
Duloxetine significantly reduces knee osteoarthritis pain and improves physical function, as shown in a systematic review of 6 studies with 2059 patients, indicating its efficacy as a treatment option.
Despite its effectiveness, duloxetine did not show a significant difference in serious adverse events compared to placebo, suggesting it may have a similar safety profile, but further well-controlled studies are needed.
An Updated Systematic Review and Meta-analysis of Duloxetine for Knee Osteoarthritis Pain.Chen, B., Duan, J., Wen, S., et al.[2023]
In a long-term study of duloxetine for major depressive disorder involving 177 patients, the treatment maintained efficacy with a mean Hamilton Depression Rating scale score below 7, indicating sustained improvement in depression symptoms over an average of 305 days.
Only 7% of patients experienced clinically significant worsening of depression leading to discontinuation, and while 11.9% discontinued due to adverse events, most were not unique to the long-term phase, suggesting duloxetine is generally well-tolerated.
Long-term tolerability and effectiveness of duloxetine in the treatment of major depressive disorder.Dunner, DL., Wilson, M., Fava, M., et al.[2015]

References

Does Screening for Depressive Symptoms Help Optimize Duloxetine Use in Knee Osteoarthritis Patients With Moderate Pain? A Cost-Effectiveness Analysis. [2023]
An Updated Systematic Review and Meta-analysis of Duloxetine for Knee Osteoarthritis Pain. [2023]
Efficacy and safety of duloxetine in osteoarthritis: a systematic review and meta-analysis. [2020]
Duloxetine: a review. [2009]
The efficacy and safety of duloxetine for the treatment of patients after TKA or THA: A systematic review and meta-analysis. [2023]
Long-term tolerability and effectiveness of duloxetine in the treatment of major depressive disorder. [2015]
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]
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 and Subacute Pain after Knee Arthroplasty when Added to a Multimodal Analgesic Regimen: A Randomized, Placebo-controlled, Triple-blinded Trial. [2018]
Duloxetine versus other anti-depressive agents for depression. [2022]
Current Opinions about the Use of Duloxetine: Results from a Survey Aimed at Psychiatrists. [2023]
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