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Recruiting NCT05976347

Identifying and Treating Depression in the Orthopaedic Trauma Population

Phase IV Interventional Depression

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Fluoxetine 20 MG, Duloxetine 30 MG, Observation.
Who it may be relevant to
Registry conditions: Depression. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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?

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.

Interventions

  • Drug Fluoxetine 20 MG
    Fluoxetine 20 mg once daily
  • Drug Duloxetine 30 MG
    Duloxetine 30 mg once daily
  • Other Observation
    Referral to behavioral health and resources for addressing depressive symptoms

Primary outcome measures

  • Depressive Symptom Scores [Time frame: Baseline]
  • Depressive Symptom Scores [Time frame: Month 3]
  • Depressive Symptom Scores [Time frame: Month 6]
  • Depressive Symptom Scores [Time frame: Month 9]
  • Depressive Symptom Scores [Time frame: Year 1]
Secondary outcome measures (9)
  • Adherence to Treatment Percentage [Time frame: Months 3, 6, and 12]
  • Utilization of non-pharmaceutical tools and resources Percentage [Time frame: Months 3, 6, and 12]
  • Patient Reported Outcome Measures - PROMIS-29 Scores [Time frame: Months 3, 6, and 12]
  • Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores [Time frame: Months 3, 6, and 12]
  • Patient Reported Outcome Measures - Brief Pain Inventory Scores [Time frame: Months 3, 6, and 12]
  • Healthcare Utilization - The number of hospitalizations and ED visits [Time frame: Months 3, 6, and 12]
  • Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9) [Time frame: Months 3, 6, and 12]
  • Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12) [Time frame: Months 3, 6, and 12]
  • Qualitative Interview Information [Time frame: One time between 6-12 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Wake Forest University Health Sciences — Winston-Salem

Identifiers

NCT: NCT05976347 · IRB00096491 · MSKRSH040123

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗