Screening and treating depression in orthopedic trauma patients
Official title: Identifying and Treating Depression in the Orthopaedic Trauma Population
Run by Wake Forest University Health Sciences · NCT05976347 · Data updated 2026-11-12
This pilot will test whether screening orthopedic trauma patients for depression and offering fluoxetine or duloxetine improves depressive symptoms and recovery compared with choosing no medication.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Status | Recruiting |
| Started | June 25, 2025 |
| Main results expected | May 2027 |
| Study ends | May 2027 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT05976347 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18+) presenting to the Wake Forest orthopedic trauma clinic after operative extremity or pelvic fracture with a PHQ-9 score ≥5 who are not currently taking antidepressants and who speak English or Spanish.
✕Probably not a fit
Patients already on antidepressant therapy, those with bipolar or psychotic disorders, active suicidal ideation, or contraindications to fluoxetine/duloxetine are unlikely to benefit from this protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Wake Forest investigators will pilot a protocol in which orthopedic trauma patients are screened with the PHQ-9 at their first post-operative visit and those scoring ≥5 are offered fluoxetine 20 mg, duloxetine 30 mg, or observation. Patients already on antidepressants, with bipolar or psychotic disorders, active suicidal ideation, or contraindications to study drugs are excluded. Outcomes tracked include change in depressive symptoms, pain, opioid consumption, patient-reported functional outcomes, complications, and length of stay over follow-up visits. The trial is single-site and limited to adults who speak English or Spanish and present after operative extremity or pelvic fracture.
Why it matters
Potential benefit: If successful, this approach could reduce depression symptoms and improve pain control, opioid use, and functional recovery for orthopedic trauma patients.
How similar studies have gone: Prior work shows treating depression in medical and surgical populations can improve mood and recovery, but integrating antidepressant prescribing into orthopedic trauma clinics has been less widely tested.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States Recruiting
Study contacts
- Principal investigator: Meghan K Wally, PhD — Wake Forest University Health Sciences
- Study coordinator: Erica Grochowski, MPH
- Email: Erica.Grochowski@advocatehealth.org
- Phone: 704-403-4980
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.