Identifying and Treating Depression in the Orthopaedic Trauma Population
Part of paid clinical trials in Winston-Salem, North Carolina.
- Sponsor
- Wake Forest University Health Sciences
- Study ID
- NCT05976347
- Phase
- PHASE4
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Fluoxetine 20 MG — DRUGFluoxetine 20 mg once daily
- Duloxetine 30 MG — DRUGDuloxetine 30 mg once daily
- Observation — OTHERReferral to behavioral health and resources for addressing depressive symptoms
Study Details
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?
Key Dates
- Start date
- Jun 25, 2025
- Status verified
- Apr 2026
- Primary completion
- May 31, 2027
- Completion
- May 31, 2027
Study Design
- Enrollment
- 100 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Selective serotonin reuptake inhibitors (SSRI)Fluoxetine, 20mg once daily
- Experimental: serotonin and norepinephrine reuptake inhibitors (SNRI)Duloxetine, 30mg once daily
- Other: ObservationalReferral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.
Primary Outcome Measure
Depressive Symptom Scores [ Time Frame: Baseline ]
Central Contacts
- Erica Grochowski, MPH704-403-4980
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 |
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