Recruiting

Depression with Medication

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05976347

Conditions

Depression

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fluoxetine 20 MG

Duloxetine 30 MG

Observation

Study Details

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?

Conditions

Depression

Study ID

NCT05976347

Start date

Jun 25, 2025

Status verified date

Apr, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Selective serotonin reuptake inhibitors (SSRI)

Fluoxetine, 20mg once daily

experimental: serotonin and norepinephrine reuptake inhibitors (SNRI)

Duloxetine, 30mg once daily

other: Observational

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

Interventions

Fluoxetine 20 MG

Fluoxetine 20 mg once daily

Duloxetine 30 MG

Duloxetine 30 mg once daily

Observation

Referral to behavioral health and resources for addressing depressive symptoms

Primary outcome measure

  • Depressive Symptom Scores [ Time Frame: Baseline ]
  • Depressive Symptom Scores [ Time Frame: Month 3 ]
  • Depressive Symptom Scores [ Time Frame: Month 6 ]
  • Depressive Symptom Scores [ Time Frame: Month 9 ]
  • Depressive Symptom Scores [ Time Frame: Year 1 ]

Central Contacts and Locations

Central contacts

Erica Grochowski, MPH

704-403-4980Erica.Grochowski@advocatehealth.org

Locations

Wake Forest University Health Sciences

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Erica Grochowski, MPH

704-403-4980Erica.Grochowski@atriumhealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

May 22, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-05-22.