DepressionPhase 4NCT05976347
Identifying and Treating Depression in the Orthopaedic Trauma Population
A Phase 4 study testing Fluoxetine 20 MG, Duloxetine 30 MG and Observation in people with Depression, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Fluoxetine 20 MG, Duloxetine 30 MG and Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jun 2025to May 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Currently taking medication to treat depression
- Contraindication/allergy to one of the study medications
- Bipolar disorder of psychotic disorder
- Endorse suicidal ideation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Erica Grochowski, MPH, 704-403-4980, Erica.Grochowski@atriumhealth.org
About this study
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:
- 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).
- What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?
Read the detailed description
Depression is common among orthopaedic trauma patients and associated with worsened outcomes including pain, opioid consumption, patient-reported outcomes ,complications, and length of stay. Addressing depression, therefore, should lead to improved outcomes. Orthopaedic surgeons may believe treating depression is outside their scope or that they lack tools to address depressive symptoms. In fact, only 45% of surgeons report they are likely to screen patients, and only 27% are likely to refer patients for psychological treatment.
- Conditions
- Depression
- Being tested
- Fluoxetine 20 MG, Duloxetine 30 MG, Observation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoxetine 20 MGDrug
Also called Prozac Weekly, Sarafem, Prozac
Fluoxetine 20 mg once daily
Duloxetine 30 MGDrug
Also called Irenka and Cymbalta
Duloxetine 30 mg once daily
ObservationOther
Also called Referral to behavioral health and resources
Referral to behavioral health and resources for addressing depressive symptoms
| Study group | Role | What they receive |
|---|---|---|
| Selective serotonin reuptake inhibitors (SSRI) | Experimental | Fluoxetine, 20mg once daily Receives: Drug: Fluoxetine 20 MG |
| serotonin and norepinephrine reuptake inhibitors (SNRI) | Experimental | Duloxetine, 30mg once daily Receives: Drug: Duloxetine 30 MG |
| Observational | Other | Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Year 1
Secondary outcomes (9)
Adherence to Treatment Percentage
Adherence to treatment and side effects or adverse events associated with the medications will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of prescriptions filled).
Measured: Months 3, 6, and 12
Utilization of non-pharmaceutical tools and resources Percentage
Engagement with behavioral health resources will be collected using patient logs, study visit questionnaires, and the medical record (i.e., number of visits with Behavioral Health).
Measured: Months 3, 6, and 12
Patient Reported Outcome Measures - PROMIS-29 Scores
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean a higher level of disability.
Measured: Months 3, 6, and 12
Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores
The Work Productivity and Activity Impairment questionnaire measures how work productivity and activities are impaired by a specific health condition or disease. Scores are expressed as a percentage of impairment/productivity loss, a high score indicates greater impairment.
Measured: Months 3, 6, and 12
Patient Reported Outcome Measures - Brief Pain Inventory Scores
Assesses the severity of pain and the impact of pain on daily functions. Assesses the severity of and impact of pain on daily function. Patients are asked to rate their current symptoms, average experiences of pain, and the minimum and maximum intensities of their symptoms on scales that range from 1-10. A total pain severity score can be found by averaging these items or a single items can be treated as the primary outcome. Higher scores indicate greater severity and more interference.
Measured: Months 3, 6, and 12
Healthcare Utilization - The number of hospitalizations and ED visits
The number of hospitalizations and ED visits
Measured: Months 3, 6, and 12
Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9)
A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression. The higher the score, the more symptoms of depression experienced, and the more severe the depression is.
Measured: Months 3, 6, and 12
Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12)
Measures health related quality of life across 7 domains. The answers are summarized into two scores - a Physical Component Score and a Mental Component Score.
Measured: Months 3, 6, and 12
Qualitative Interview Information
Patients in the observational arm will participate in semi-structured interviews. Interviews will be recorded and transcribed verbatim within one week. Field notes will be written within one week of each interview, and the interview guide will be revised as appropriate.
Measured: One time between 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start25 Jun 2025
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan K Wally, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05976347
- Sponsor's protocol ID
- IRB00096491
- Other IDs
- MSKRSH040123
- Status last verified
- Apr 2026
- First submitted
- 28 Jul 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying and Treating Depression in the Orthopaedic Trauma Population
- ClinicalTrials.gov ID
- NCT05976347
- Acronym / sponsor ID
- IRB00096491
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- What are the outcomes of patients who screen positive for depressive symptoms and choose not to pursue treatment with medication?
Detailed description
Depression is common among orthopaedic trauma patients and associated with worsened outcomes including pain, opioid consumption, patient-reported outcomes ,complications, and length of stay. Addressing depression, therefore, should lead to improved outcomes. Orthopaedic surgeons may believe treating depression is outside their scope or that they lack tools to address depressive symptoms. In fact, only 45% of surgeons report they are likely to screen patients, and only 27% are likely to refer patients for psychological treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Selective serotonin reuptake inhibitors (SSRI) | Experimental | Drug: Fluoxetine 20 MGFluoxetine, 20mg once daily |
| serotonin and norepinephrine reuptake inhibitors (SNRI) | Experimental | Drug: Duloxetine 30 MGDuloxetine, 30mg once daily |
| Observational | Other | Other: ObservationReferral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Currently taking medication to treat depression
- Contraindication/allergy to one of the study medications
- Bipolar disorder of psychotic disorder
- Endorse suicidal ideation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoxetine 20 MGAlso: Prozac Weekly, Sarafem, ProzacFluoxetine 20 mg once daily | Drug | Selective serotonin reuptake inhibitors (SSRI) |
| Duloxetine 30 MGAlso: Irenka and CymbaltaDuloxetine 30 mg once daily | Drug | serotonin and norepinephrine reuptake inhibitors (SNRI) |
| ObservationAlso: Referral to behavioral health and resourcesReferral to behavioral health and resources for addressing depressive symptoms | Other | Observational |
Primary outcome
Depressive Symptom Scores
Time frame: Baseline
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.
Depressive Symptom Scores
Time frame: Month 3
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.
Depressive Symptom Scores
Time frame: Month 6
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.
Depressive Symptom Scores
Time frame: Month 9
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.
Depressive Symptom Scores
Time frame: Year 1
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.
9 secondary outcomes
Adherence to Treatment Percentage
Time frame: Months 3, 6, and 12
Utilization of non-pharmaceutical tools and resources Percentage
Time frame: Months 3, 6, and 12
Patient Reported Outcome Measures - PROMIS-29 Scores
Time frame: Months 3, 6, and 12
Patient Reported Outcome Measures - Work Productivity and Activity Impairment Questionnaire Scores
Time frame: Months 3, 6, and 12
Patient Reported Outcome Measures - Brief Pain Inventory Scores
Time frame: Months 3, 6, and 12
Healthcare Utilization - The number of hospitalizations and ED visits
Time frame: Months 3, 6, and 12
Patient Reported Outcome Measures: Patient Health Questionnaire 9 (PHQ-9)
Time frame: Months 3, 6, and 12
Patient Reported Outcome Measures - Veterans RAND 12 Item Health Survey (VR-12)
Time frame: Months 3, 6, and 12
Qualitative Interview Information
Time frame: One time between 6-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meghan K Wally, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluoxetine 20 MG, Duloxetine 30 MG and Observation in people with Depression, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erica Grochowski, MPH (704-403-4980, Erica.Grochowski@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive Symptom Scores (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.