Anxiety & Depression Association of America

Identifying and Treating Depression in the Orthopaedic Trauma Population

Purpose

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?

Condition

Depression

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

Patients presenting to an Orthopaedic trauma clinic for the first time following operative extremity fracture or any pelvis fracture - A score of greater than or equal to 5 on the Patient Health Questionnaire-9 (PHQ-9) at first post- operative visit - Age 18 or older - Speak English or Spanish

Exclusion Criteria

Currently taking medication to treat depression - Contraindication/allergy to one of the study medications - Bipolar disorder of psychotic disorder - Endorse suicidal ideation

Study Design

Phase: Phase 4
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients will be randomized to receive either an Selective serotonin reuptake inhibitors (SSRI) or serotonin and norepinephrine reuptake inhibitors (SNRI), and patients who are not interested in taking medication for their symptoms will be enrolled in an observational arm.
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Selective serotonin reuptake inhibitors (SSRI)	Fluoxetine, 20mg once daily	Drug: Fluoxetine 20 MG Fluoxetine 20 mg once daily Other names: Prozac Weekly, Sarafem, Prozac
Experimental serotonin and norepinephrine reuptake inhibitors (SNRI)	Duloxetine, 30mg once daily	Drug: Duloxetine 30 MG Duloxetine 30 mg once daily Other names: Irenka and Cymbalta
Other Observational	Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.	Other: Observation Referral to behavioral health and resources for addressing depressive symptoms Other names: Referral to behavioral health and resources

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Wake Forest University Health Sciences

Study Contact

Erica Grochowski, MPH
704-403-4980
Erica.Grochowski@atriumhealth.org

Detailed Description

Depression is common among orthopaedic trauma patients and associated with worsened outcomes including pain, opioid consumption, patient-reported outcomes ,complications, and length of stay. Addressing depression, therefore, should lead to improved outcomes. Orthopaedic surgeons may believe treating depression is outside their scope or that they lack tools to address depressive symptoms. In fact, only 45% of surgeons report they are likely to screen patients, and only 27% are likely to refer patients for psychological treatment.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.