Depression in Old AgePhase 4SNRINCT05851898
Serotonin-norepinephrine Reuptake Inhibitor in Prophylaxis of Depression Following Fragility Fractures
A Phase 4 study testing Duloxetine 30 mg in people with Depression in Old Age and Fragility Fracture, run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Depression in Old Age, Fragility Fracture
- What is being tested?
- Duloxetine 30 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Apr 2024to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Geriatric (greater than or equal to 65 years old)
- Lower extremity fragility fractures managed operatively
Who cannot join
- 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
Show all 9Show fewer
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
Erica, MPH, 704-403-4980, Erica.Grochowski@atriumhealth.org
Rachel Seymour, PhD
About this study
Official title: The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients
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?
Read more
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
Read the detailed description
As with many mental health diagnoses, there continues to be a stigma against receiving treatment and potentially even more so receiving prophylaxis16. Identifying these hurdles at the patient level will allow us to better educate patients and physicians about the benefits of this intervention. Secondly, this pilot study will help us determine if it is possible to start prescribing SNRI medication upon discharge. It will allow us to navigate the procurement of medications through Medicare, prescribing practices at discharge and address patient concerns regarding starting a new medication.
- Conditions
- Depression in Old Age, Fragility Fracture
- Being tested
- Duloxetine 30 mg
- Keywords
- Geriatrics, Serotonin-norepinephrine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Duloxetine 30 mgDrug
Also called Common brands: Irenka, Cymbalta
Duloxetine 30mg daily prescribed at discharge
| Study group | Role | What they receive |
|---|---|---|
| Duloxetine 30mg | Experimental | Duloxetine 30mg daily 90 day supply and 3 refills Receives: Drug: Duloxetine 30 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geriatric Depression Scale (Short Form) Scores
This scale will be used as the primary outcome in this study as an indicator of patients who develop depression post-operatively. Scores range from 1-15. A score of 5 or greater indicates depression.
Measured: Baseline
Geriatric Depression Scale (Short Form) Scores
This scale will be used as the primary outcome in this study as an indicator of patients who develop depression post-operatively. Scores range from 1-15. A score of 5 or greater indicates depression.
Measured: up to 1 year
Secondary outcomes (7)
PROMIS-29 Subscale Scores - Depression
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores means higher depression.
Measured: Month 3, Month 6, and Year 1
PROMIS-29 Subscale Scores - Physical Function
The PROMIS-29 scales will be scored using a T-score metric method. A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Possible scores range from 0 to 100, with higher scores representing better health status
Measured: Month 3, Month 6, and Year 1
Number of patients who have side effects from the medication
Number of patients who have side effects from the medication
Measured: Baseline, monthly up to 1 year
Number of participants who undergo re-operation
Number of participants who undergo re-operation
Measured: Baseline, monthly up to 1 year
Number of participants who are readmitted to the hospital
Number of participants who are readmitted to the hospital
Measured: Baseline, monthly up to 1 year
Mortality Rate
Mortality Rate
Measured: Baseline, monthly up to 1 year
Number of participants who re-fracture the study injury
Number of participants who re-fracture
Measured: Baseline, monthly up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start8 Apr 2024
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression in Old AgeStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- geriatric patients with operative lower extremity fragility fractures that will be started on Serotonin-norepinephrine reuptake inhibitor (SNRI) medication immediately after obtaining consent at index hospitalization or first post operative clinic appointment
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Seymour, PhD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05851898
- Sponsor's protocol ID
- IRB00095504
- Acronym
- SNRI
- Status last verified
- Mar 2026
- First submitted
- 1 May 2023
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of SNRI's in the Prophylaxis of Depression in the First Year Following Lower Extremity Fragility Fractures in Geriatric Patients
- ClinicalTrials.gov ID
- NCT05851898
- Acronym / sponsor ID
- SNRI / IRB00095504
- Conditions
- Depression in Old Age, Fragility Fracture
- Keywords
- Geriatrics, Serotonin-norepinephrine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 8 Apr 2024 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
As with many mental health diagnoses, there continues to be a stigma against receiving treatment and potentially even more so receiving prophylaxis16. Identifying these hurdles at the patient level will allow us to better educate patients and physicians about the benefits of this intervention. Secondly, this pilot study will help us determine if it is possible to start prescribing SNRI medication upon discharge. It will allow us to navigate the procurement of medications through Medicare, prescribing practices at discharge and address patient concerns regarding starting a new medication.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- geriatric patients with operative lower extremity fragility fractures that will be started on Serotonin-norepinephrine reuptake inhibitor (SNRI) medication immediately after obtaining consent at index hospitalization or first post operative clinic appointment
| Arm | Type | Receives |
|---|---|---|
| Duloxetine 30mg | Experimental | Drug: Duloxetine 30 mgDuloxetine 30mg daily 90 day supply and 3 refills |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Geriatric (greater than or equal to 65 years old)
- Lower extremity fragility fractures managed operatively
Key exclusion criteria (9 listed)
- Polytrauma
- Pathological fractures
- Patients on hospice
- Patients with previously diagnosed psychiatric disorders
- Patients with previously diagnosed dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Duloxetine 30 mgAlso: Common brands: Irenka, CymbaltaDuloxetine 30mg daily prescribed at discharge | Drug | Duloxetine 30mg |
Primary outcome
Geriatric Depression Scale (Short Form) Scores
Time frame: Baseline
This scale will be used as the primary outcome in this study as an indicator of patients who develop depression post-operatively. Scores range from 1-15. A score of 5 or greater indicates depression.
Geriatric Depression Scale (Short Form) Scores
Time frame: up to 1 year
This scale will be used as the primary outcome in this study as an indicator of patients who develop depression post-operatively. Scores range from 1-15. A score of 5 or greater indicates depression.
7 secondary outcomes
PROMIS-29 Subscale Scores - Depression
Time frame: Month 3, Month 6, and Year 1
PROMIS-29 Subscale Scores - Physical Function
Time frame: Month 3, Month 6, and Year 1
Number of patients who have side effects from the medication
Time frame: Baseline, monthly up to 1 year
Number of participants who undergo re-operation
Time frame: Baseline, monthly up to 1 year
Number of participants who are readmitted to the hospital
Time frame: Baseline, monthly up to 1 year
Mortality Rate
Time frame: Baseline, monthly up to 1 year
Number of participants who re-fracture the study injury
Time frame: Baseline, monthly up to 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rachel Seymour, PhD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Duloxetine 30 mg in people with Depression in Old Age and Fragility Fracture, run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erica Grochowski, MPH (704-403-4980, Erica.Grochowski@advocatehealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geriatric Depression Scale (Short Form) Scores (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2026.