Your session is about to expire
← Back to Search
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 up to 1 year
Awards & highlights
SNRI 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.Check my eligibility
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.See study design
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.
SNRI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Geriatric Depression Scale (Short Form) Scores
Secondary outcome measures
Mortality Rate
Number of participants who are readmitted to the hospital
Number of participants who re-fracture the study injury
+4 moreSide effects data
From 2015 Phase 4 trial • 106 Patients • NCT020056012%
Atrial fibrillation
2%
Nausea
2%
Headache
100%
80%
60%
40%
20%
0%
Study treatment Arm
Control
Duloxetine
SNRI 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
1,243 Previous Clinical Trials
1,004,626 Total Patients Enrolled
Rachel Seymour, PhDPrincipal InvestigatorWake Forest University Health Sciences
4 Previous Clinical Trials
1,663 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a fracture caused by a disease.I have a serious health condition that could shorten my life.I am 65 years old or older.I had surgery for a fragile bone fracture in my leg.I am currently taking medication for depression or anxiety.I am currently on medication for mood stabilization.
Research Study Groups:
This trial has the following groups:- Group 1: Duloxetine 30mg
Awards:
This trial has 3 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the US Food and Drug Administration recognize Duloxetine 30mg as a safe treatment?
"On a scale of 1 to 3, duloxetine 30mg scored a 3 due to its status as an approved treatment in Phase 4 clinical trials."
Answered by AI
Is enrollment for this research still taking place?
"The clinicaltrials.gov website indicates that this particular medical study is not presently recruiting participants; the trial was initially announced on June 1st 2023, and the details were most recently edited on May 9th 2023. Nonetheless, there are upwards of 1715 other studies actively seeking patient involvement at present."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger