Identifying and Treating Depression in Orthopaedic Trauma Patients

This study aims to find better ways for orthopaedic surgeons to identify and treat depression in patients who have experienced a bone fracture requiring surgery. Researchers want to see how patients who screen positive for depression respond to either Fluoxetine 20 MG or Duloxetine 30 MG, which are medications commonly used for depression. They will also look at outcomes for patients who choose not to take medication but are referred to behavioral health resources. You might be able to join if you are 18 or older, speak English or Spanish, have recently had an orthopaedic trauma, and score 5 or higher on a depression screening questionnaire (PHQ-9). The study will measure changes in your depression symptoms over 6 months. The current status of this study is unclear, and it plans to enroll 100 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment or intervention. It plans to enroll 100 participants.
What's involved
Your depressive symptom scores will be measured at the start of the study, and then again at 3 months and 6 months.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 6 months after starting the study.

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NCT05976347

Identifying and Treating Depression in the Orthopaedic Trauma Population

Recruiting
PHASE4Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~100 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Fluoxetine 20 MGDuloxetine 30 MGObservation

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Depressive Symptom Scores
Measured over Baseline
+4 more outcomes measured
Depression

NCT05976347

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolinastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Meghan K Wally, PhD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

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Eligibility criteria

Inclusion

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

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

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.

  • Depressive Symptom ScoresMonth 3

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.

  • Depressive Symptom ScoresMonth 6

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.

  • Depressive Symptom ScoresMonth 9

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.

  • Depressive Symptom ScoresYear 1

    Improvement in depressive symptoms, indication by either remission (PHQ-9 score \<5) or a 50% reduction in PHQ-9 score. The Patient Health Questionnaire (PHQ-9) is a self-report tool that incorporates DSM-IV depression diagnostic criteria with other leading major depressive symptoms. The too rates the frequency of the symptoms which factors into the scoring severity index. PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe and severe depression.