Identifying and Treating Depression in the Orthopaedic Trauma Population

Trial tests depression treatment for bone fracture patients

NCT: NCT05976347 · Status: RECRUITING · Phase: Phase 4 · Sponsor: Wake Forest University Health Sciences · Started: 2025-06-25 · Est. Completion: 2026-05

Plain English Summary

Identifying and Treating Depression in the Orthopaedic Trauma Population is a Phase 4 clinical trial sponsored by Wake Forest University Health Sciences studying Depression. This study tests if common depression medications (SSRI/SNRI) help patients with bone fractures who also have depression. It is for adults (18+) who have had a recent bone fracture, are recovering from surgery, and show signs of depression. Participants will be screened for depression and may be offered medication or other support, with regular check-ins. Alternatives include seeking mental health support independently or discussing treatment options with your doctor. The trial aims to enroll 100 participants.

Official 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?

Who Can Participate

Here is what you need to know about eligibility for this trial. You can join if you are 18 or older, have had a recent bone fracture (extremity or pelvis) requiring surgery, and score above a certain level on a depression questionnaire. You cannot join if you are already taking depression medication, have bipolar or psychotic disorders, or have thoughts of harming yourself. You must be able to speak English or Spanish. Allergies or contraindications to the study medications will also exclude you. This trial is studying Depression, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.

What They're Measuring

The primary outcome measures track how much a patient's depression symptoms improve over a year, indicating how effective the treatments are in reducing feelings of sadness and hopelessness. The specific primary outcome measures are: Depressive Symptom Scores (Baseline); Depressive Symptom Scores (Month 3); Depressive Symptom Scores (Month 6); Depressive Symptom Scores (Month 9); Depressive Symptom Scores (Year 1). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.

About This Phase

This is a Phase 4 (post-marketing) study of a treatment that has already received FDA approval. Phase 4 trials monitor long-term safety, effectiveness in broader patient populations, and potential interactions with other treatments in real-world settings. These studies can involve thousands of patients and help identify rare side effects that may not have appeared in earlier, smaller trials.

Why This Trial Matters

This trial addresses a gap in care by integrating depression screening and treatment into orthopedic trauma care, aiming to improve recovery for patients with both physical and mental health challenge This research targets Depression, where improved treatment options are needed.

Investor Insight

This trial signals a growing focus on integrated care models, potentially expanding the market for mental health treatments within specialized medical fields and suggesting a need for accessible solut This treatment is already approved and on the market. This post-marketing study monitors real-world outcomes.

Is This Trial Right for Me?

Ask your doctor about the specific medications being tested and their potential side effects. Understand how your depression symptoms will be monitored throughout the study. Be prepared for regular follow-up appointments to assess your progress and any side effects. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.

AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.

Study Design

Interventions

Primary Outcomes

Secondary Outcomes

Full 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

Trial Locations

Frequently Asked Questions

What is clinical trial NCT05976347?

NCT05976347 is a Phase 4 INTERVENTIONAL study titled "Identifying and Treating Depression in the Orthopaedic Trauma Population." It is currently recruiting and is sponsored by Wake Forest University Health Sciences. The trial targets enrollment of 100 participants.

What conditions does NCT05976347 study?

This trial investigates treatments for Depression. The primary condition under study is Depression.

What treatments are being tested in NCT05976347?

The interventions being studied include: Fluoxetine 20 MG (DRUG), Duloxetine 30 MG (DRUG), Observation (OTHER). Fluoxetine 20 mg once daily

What does Phase 4 mean for NCT05976347?

Phase 4 trials occur after a treatment is already approved and on the market. They monitor long-term effectiveness and safety in larger populations under real-world conditions.

What is the current status of NCT05976347?

This trial is currently "Recruiting." It started on 2025-06-25. The estimated completion date is 2026-05.

Who is sponsoring NCT05976347?

NCT05976347 is sponsored by Wake Forest University Health Sciences. The sponsor is responsible for funding, designing, and overseeing the clinical trial.

How many people can participate in NCT05976347?

The trial aims to enroll 100 participants. The trial is currently recruiting and accepting new participants.

How is NCT05976347 designed?

This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.

What are the primary outcomes being measured in NCT05976347?

The primary outcome measures are: Depressive Symptom Scores (Baseline); Depressive Symptom Scores (Month 3); Depressive Symptom Scores (Month 6); Depressive Symptom Scores (Month 9); Depressive Symptom Scores (Year 1). These are the main endpoints researchers use to determine whether the treatment is effective.

Where is NCT05976347 being conducted?

This trial is being conducted at 1 site, including Winston-Salem, North Carolina (United States).

Where can I find official information about NCT05976347?

The official record for NCT05976347 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05976347. This government database provides the most up-to-date and detailed information about the trial.

What is NCT05976347 testing in simple terms?

This study tests if common depression medications (SSRI/SNRI) help patients with bone fractures who also have depression. It is for adults (18+) who have had a recent bone fracture, are recovering from surgery, and show signs of depression.

Why is this trial significant?

This trial addresses a gap in care by integrating depression screening and treatment into orthopedic trauma care, aiming to improve recovery for patients with both physical and mental health challenge

What are the potential risks of participating in NCT05976347?

Potential side effects of the study medications include nausea, insomnia, or changes in appetite. Some patients may not respond to the medication, or may experience worsening of symptoms. There is a risk of allergic reaction to the study drugs. As with any clinical trial, participants are closely monitored and can withdraw at any time.

Should I consider participating in NCT05976347?

Ask your doctor about the specific medications being tested and their potential side effects. Understand how your depression symptoms will be monitored throughout the study. Be prepared for regular follow-up appointments to assess your progress and any side effects. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.

What does NCT05976347 signal from an investment perspective?

This trial signals a growing focus on integrated care models, potentially expanding the market for mental health treatments within specialized medical fields and suggesting a need for accessible solut This is a Phase 4 trial, which is in early development stages.

What happens if the treatment in this trial doesn't work?

Participants will be screened for depression and may be offered medication or other support, with regular check-ins. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.

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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.