Using antidepressants to prevent depression after fragility fractures in older adults
The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients
This study is testing if giving antidepressants to older adults with leg fractures when they leave the hospital can help prevent depression.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Wake Forest University Health Sciences Academic / other |
| Locations | 1 site (Winston-Salem, North Carolina) |
| Trial ID | NCT05851898 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility of prescribing serotonin-norepinephrine reuptake inhibitors (SNRIs) to older patients with lower extremity fragility fractures at the time of discharge. It will explore barriers to patient enrollment and medication prescription, evaluate the prevalence of depressive symptoms in this population, and develop a transition of care plan for those requiring further mental health support. Participants will be screened for depression, prescribed Duloxetine, and monitored for medication compliance and outcomes over a year.
Who should consider this trial
Good fit: Ideal candidates are geriatric patients aged 65 and older who have sustained lower extremity fragility fractures managed operatively.
Not a fit: Patients with pre-existing psychiatric disorders, dementia, or those on certain mood stabilizing medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of depression in older adults recovering from fragility fractures.
How similar studies have performed: While the approach of using SNRIs for depression prophylaxis in this specific context is novel, similar studies have shown promise in addressing depression in older adults.
Eligibility criteria
Show full inclusion / exclusion 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.)
Where this trial is running
Winston-Salem, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Rachel Seymour, PhD — Wake Forest University Health Sciences
- Study coordinator: Erica Grochowski, MPH
- Email: Erica.Grochowski@advocatehealth.org
- Phone: 704-403-4980
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.