Antidepressants for Depression in Orthopaedic Trauma Patients

Recruiting in Palo Alto (17 mi)

Overseen by Meghan K Wally, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Prior Safety Data

Trial Summary

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

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

I am 18 years old or older.

Exclusion Criteria

I am currently on medication for depression.

Endorse suicidal ideation

Contraindication/allergy to one of the study medications

Treatment Details

Interventions

• Duloxetine (Serotonin and norepinephrine reuptake inhibitors (SNRI))
• Fluoxetine (Selective serotonin reuptake inhibitors (SSRI))
• Observation (Other)

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

Group I: serotonin and norepinephrine reuptake inhibitors (SNRI) Experimental Treatment 1 Intervention

Duloxetine, 30mg once daily

Group II: Selective serotonin reuptake inhibitors (SSRI) Experimental Treatment 1 Intervention

Fluoxetine, 20mg once daily

Group III: Observational Experimental Treatment 1 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

Research Locations Nearby Select from list below to view details:

Wake Forest University Health Sciences Winston-Salem, NC

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1432

Patients Recruited

2,506,000+