Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures
Launched by WAKE FOREST UNIVERSITY HEALTH SCIENCES · May 9, 2023
Trial Information
Current as of August 25, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the use of a specific type of antidepressant, called Duloxetine, to see if it can help prevent depression in older adults who have had a lower extremity fragility fracture, which means a break in a bone from a fall or minor injury. The trial aims to find out if doctors can easily prescribe this medication when patients are discharged from the hospital, and to understand how common depressive symptoms are among patients with different types of injuries. It also explores what kind of ongoing care these patients might need after leaving the hospital.
To participate, you need to be 65 years or older and have had a lower leg fracture that was treated with surgery. During the trial, participants will complete a depression screening before starting the medication and will take Duloxetine daily after discharge. They will be asked to report how well they are taking the medication and will fill out additional surveys about their mood over the next year. If any patient shows signs of depression at any point, they will be referred to a healthcare professional for further help. The trial is currently recruiting participants, and it is important to note that people with certain conditions, like severe mental health issues or those on specific medications, cannot participate.
Gender
ALL
Eligibility criteria
- 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.)
About Wake Forest University Health Sciences
Wake Forest University Health Sciences is a leading academic research institution dedicated to advancing healthcare through innovative clinical trials and translational research. With a strong emphasis on multidisciplinary collaboration, the organization leverages its extensive expertise in medical research, patient care, and education to develop and evaluate new therapies and interventions. Committed to improving patient outcomes and public health, Wake Forest University Health Sciences fosters a dynamic environment for scientific inquiry, engaging in a wide range of clinical studies that address pressing health challenges. Through its rigorous methodologies and ethical standards, the institution aims to contribute significantly to the medical field and enhance the quality of life for diverse populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Winston Salem, North Carolina, United States
Patients applied
Trial Officials
Rachel Seymour, PhD
Principal Investigator
Wake Forest University Health Sciences
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported