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NCT05976347 · ClinicalTrials.gov registry record · Phase 4
Identifying and Treating Depression in the Orthopaedic Trauma Population
A Phase 4 study of Depression, sponsored by Wake Forest University Health Sciences.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT05976347: Recruiting Phase 4 study of Depression, sponsored by Wake Forest University Health Sciences.
NCT05976347 is a Phase 4 study of Depression that is actively recruiting participants, run by Wake Forest University Health Sciences. The registered enrollment target is 100 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05976347, a Phase 4 study of Depression, is actively recruiting participants, sponsored by Wake Forest University Health Sciences.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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?
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Observation
- DRUG Fluoxetine 20 MG
- DRUG Duloxetine 30 MG
Study Locations (1)
North Carolina
- Wake Forest University Health Sciences - Winston-Salem
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2025-06-25 |
| Est. Completion | 2026-05 |
| Phase | Phase 4 |
What NCT05976347 shows while recruiting
NCT05976347 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 786-participant average among 679 other Depression trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Depression appearing as the primary indexed condition, and to 3 interventions - of which Observation is the first listed.
NCT05976347 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT05976347 about?
NCT05976347 is a clinical study titled "Identifying and Treating Depression in the Orthopaedic Trauma Population". 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 eithe...
What is the current status of trial NCT05976347?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 100 participants. The study started on 2025-06-25. Estimated completion is 2026-05.
What conditions does trial NCT05976347 study?
This clinical trial studies the following conditions: Depression.
What interventions are being tested in trial NCT05976347?
The interventions under investigation include: Observation (OTHER), Fluoxetine 20 MG (DRUG), Duloxetine 30 MG (DRUG).
Who is sponsoring clinical trial NCT05976347?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05976347 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05976347's enrollment target sits among peer trials
100 326th of 679 higher than 331 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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