Identifying and Treating Depression in the Orthopaedic Trauma Population

Wake Forest University (WFU)

Status and phase: Not yet enrolling; Phase 4

Conditions: Depression

Treatments: Drug: Fluoxetine 20 MG; Other: Observation; Drug: Duloxetine 30 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05976347

IRB00096491

MSKRSH040123 (Other Identifier)

Details and patient eligibility

About

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?

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 3 patient groups

Selective serotonin reuptake inhibitors (SSRI)

Experimental group

Description:

Fluoxetine, 20mg once daily

Treatment:

Drug: Fluoxetine 20 MG

serotonin and norepinephrine reuptake inhibitors (SNRI)

Experimental group

Description:

Duloxetine, 30mg once daily

Treatment:

Drug: Duloxetine 30 MG

Observational

Other group

Description:

Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.

Treatment:

Other: Observation