Identifying and Treating Depression in the Orthopaedic Trauma Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-25

Study Completion Date

2026-05-31

Brief Summary

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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?

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Detailed Description

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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

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Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Selective serotonin reuptake inhibitors (SSRI)

Fluoxetine, 20mg once daily

Group Type EXPERIMENTAL

Fluoxetine 20 MG

Intervention Type DRUG

Fluoxetine 20 mg once daily

serotonin and norepinephrine reuptake inhibitors (SNRI)

Duloxetine, 30mg once daily

Group Type EXPERIMENTAL

Duloxetine 30 MG

Intervention Type DRUG

Duloxetine 30 mg once daily

Observational

Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.

Group Type OTHER

Observation

Intervention Type OTHER

Referral to behavioral health and resources for addressing depressive symptoms

Interventions

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Fluoxetine 20 MG

Fluoxetine 20 mg once daily

Intervention Type DRUG

Duloxetine 30 MG

Duloxetine 30 mg once daily

Intervention Type DRUG

Observation

Referral to behavioral health and resources for addressing depressive symptoms

Intervention Type OTHER

Other Intervention Names

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Prozac Weekly, Sarafem, Prozac Irenka and Cymbalta Referral to behavioral health and resources

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No