Recruiting

Duloxetine

Sponsor:

Wake Forest University Health Sciences

Code:

NCT05851898

Conditions

Depression in Old Age

Fragility Fracture

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

Duloxetine 30 mg

Study Details

Brief summary:

The goal of this pilot study is to learn about the feasibility about prescribing anti-depressants at discharge in patients aged 50 years and older with a lower extremity fragility fracture. The main questions it aims to answer are:

  • What are the obstacles to enrolling patients and prescribing anti-depressants among older adults?
  • Is it possible to start prescribing SNRI medication upon discharge?
  • What is the prevalence of depressive symptoms amongst patients with different types of injuries and weightbearing status?
  • What is a transition of care plan for patients who have geriatric depression and require further care?

Participants will:

  • Undergo screening using the Geriatric Depression Scale
  • Start on Duloxetine 30mg daily at time of discharge
  • Report medication compliance and complete re-screening monthly
  • Complete patient reported outcome measures and 3 months, 6 months, and 1 year
  • Receive a referral to behavioral health, primary care, or psychiatrist for evaluation if they screen positive at any timepoint

Conditions

Depression in Old Age

Fragility Fracture

Study ID

NCT05851898

Start date

Apr 8, 2024

Status verified date

Mar, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Geriatric (greater than or equal to 65 years old)
  • Lower extremity fragility fractures managed operatively

Exclusion Criteria:

  • Polytrauma
  • Pathological fractures
  • Patients on hospice
  • Patients with previously diagnosed psychiatric disorders
  • Patients with previously diagnosed dementia
  • Patients already taking Selective serotonin reuptake inhibitors (SSRI)s and Serotonin- norepinephrine reuptake inhibitors (SNRI)s
  • Patients already taking mood stabilizing medication
  • Unable to provide informed consent (no use of a legal authorized representative)
  • Patients with pre-existing life limiting diagnoses (cancer, etc.)

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Duloxetine 30mg

Duloxetine 30mg daily 90 day supply and 3 refills

Interventions

Duloxetine 30 mg

Duloxetine 30mg daily prescribed at discharge

Primary outcome measure

  • Geriatric Depression Scale (Short Form) Scores [ Time Frame: Baseline ]
  • Geriatric Depression Scale (Short Form) Scores [ Time Frame: up to 1 year ]

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, MPH

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

Principal Investigator:

Rachel Seymour, PhD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 12, 2026

Last verified

Mar, 2026

Keywords

  • Geriatrics
  • Serotonin-norepinephrine

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 2026-03-12.