NCT05976347 Identifying and Treating Depression in the Orthopaedic Trauma Population
| NCT ID | NCT05976347 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-25 |
| Primary Completion | 2027-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2025-06-25 with a primary completion date of 2027-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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. 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?
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
Contact & Investigator
Meghan K Wally, PhD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT05976347 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05976347 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05976347 currently recruiting?
Yes, NCT05976347 is actively recruiting participants. Contact the research team at Erica.Grochowski@advocatehealth.org for enrollment information.
Where is the NCT05976347 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT05976347 clinical trial?
NCT05976347 is sponsored by Wake Forest University Health Sciences. The principal investigator is Meghan K Wally, PhD at Wake Forest University Health Sciences. The trial plans to enroll 100 participants.
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