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Serotonin-norepinephrine Reuptake Inhibitor

Duloxetine for Depression after Broken Bones (SNRI Trial)

Phase 4
Recruiting
Led By Rachel Seymour, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 3, month 6, and year 1
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

Summary

This trial will study if anti-depressants can be prescribed to older adults with a lower extremity fracture at discharge to reduce depressive symptoms. #Depression #Fracture #OlderAdults #Prescribing

Who is the study for?
This trial is for individuals aged 50 and older who have had a lower extremity fragility fracture (a broken bone from a fall at standing height or less) and are managed operatively. It's designed to see if starting an antidepressant, Duloxetine, when they leave the hospital can help prevent depression.
What is being tested?
The study tests whether prescribing Duloxetine 30 mg daily upon discharge is feasible for these patients. It will also assess depressive symptoms over time using the Geriatric Depression Scale and track medication compliance with monthly re-screening.
What are the potential side effects?
Duloxetine may cause nausea, dry mouth, sleepiness, fatigue, constipation, loss of appetite, sweating more than usual. Some people might feel dizzy when getting up too fast from sitting or lying down.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 3, month 6, and year 1
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 3, month 6, and year 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Geriatric Depression Scale (Short Form) Scores
Secondary study objectives
Mortality Rate
Number of participants who are readmitted to the hospital
Number of participants who re-fracture the study injury
+4 more

Side effects data

From 2015 Phase 4 trial • 106 Patients • NCT02005601
2%
Atrial fibrillation
2%
Nausea
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Duloxetine

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Duloxetine 30mgExperimental Treatment1 Intervention
Duloxetine 30mg daily 90 day supply and 3 refills

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,392 Previous Clinical Trials
2,452,755 Total Patients Enrolled
Rachel Seymour, PhDPrincipal InvestigatorWake Forest University Health Sciences
4 Previous Clinical Trials
1,663 Total Patients Enrolled

Media Library

Duloxetine (Serotonin-norepinephrine Reuptake Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05851898 — Phase 4
Fragility Fractures Research Study Groups: Duloxetine 30mg
Fragility Fractures Clinical Trial 2023: Duloxetine Highlights & Side Effects. Trial Name: NCT05851898 — Phase 4
Duloxetine (Serotonin-norepinephrine Reuptake Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05851898 — Phase 4
~22 spots leftby Feb 2025
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