Identifying and Treating Depression in the Orthopaedic Trauma Population

NCT05976347 | Recruiting Phase 4 FDA Drug

• 2 other identifiers: IRB00096491MSKRSH040123
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?

Conditions

Depression

Outcome Measures

Primary Outcomes (5)

• Depressive Symptom Scores

  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.

  Baseline

• Depressive Symptom Scores

  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.

  Month 3

• Depressive Symptom Scores

  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.

  Month 6

• Depressive Symptom Scores

  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.

  Month 9

• Depressive Symptom Scores

  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.

  Year 1

Secondary Outcomes (9)

• Adherence to Treatment Percentage

  Months 3, 6, and 12

• Utilization of non-pharmaceutical tools and resources Percentage

  Months 3, 6, and 12

• Patient Reported Outcome Measures - PROMIS-29 Scores

  Months 3, 6, and 12

• Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores

  Months 3, 6, and 12

• Patient Reported Outcome Measures - Brief Pain Inventory Scores

  Months 3, 6, and 12

Study Arms (3)

Selective serotonin reuptake inhibitors (SSRI)

EXPERIMENTAL

Fluoxetine, 20mg once daily

Drug: Fluoxetine 20 MG

serotonin and norepinephrine reuptake inhibitors (SNRI)

EXPERIMENTAL

Duloxetine, 30mg once daily

Drug: Duloxetine 30 MG

Observational

OTHER

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

Other: Observation

Interventions

Fluoxetine 20 MG DRUG

Fluoxetine 20 mg once daily

Also known as: Prozac Weekly, Sarafem, Prozac

Selective serotonin reuptake inhibitors (SSRI)

Duloxetine 30 MG DRUG

Duloxetine 30 mg once daily

Also known as: Irenka and Cymbalta

serotonin and norepinephrine reuptake inhibitors (SNRI)

Observation OTHER

Referral to behavioral health and resources for addressing depressive symptoms

Also known as: Referral to behavioral health and resources

Observational

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

RECRUITING

MeSH Terms

Conditions

Depression

Interventions

Fluoxetine; Duloxetine Hydrochloride; Observation; Health Resources

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Thiophenes; Sulfur Compounds; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methods; Investigative Techniques; Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Meghan K Wally, PhD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erica Grochowski, MPH

CONTACT

704-403-4980; Erica.Grochowski@advocatehealth.org

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: June 25, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: April 8, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)