RecruitingPhase 4NCT05976347

Identifying and Treating Depression in the Orthopaedic Trauma Population


Sponsor

Wake Forest University Health Sciences

Enrollment

100 participants

Start Date

Jun 25, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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?


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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 Criteria4

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

Interventions

DRUGFluoxetine 20 MG

Fluoxetine 20 mg once daily

DRUGDuloxetine 30 MG

Duloxetine 30 mg once daily

OTHERObservation

Referral to behavioral health and resources for addressing depressive symptoms


Locations(1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

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NCT05976347


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