Antidepressants for Depression in Orthopaedic Trauma Patients
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?
Is duloxetine generally safe for humans?
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either an SSRI or SNRI medication or are referred to behavioral health resources
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Duloxetine
- Fluoxetine
- Observation
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