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Serotonin and norepinephrine reuptake inhibitors (SNRI)
Antidepressants for Depression in Orthopaedic Trauma Patients
Phase 4
Waitlist Available
Led By Meghan K Wally, 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 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up year 1
Awards & highlights
Study Summary
This trial will look at how to safely screen orthopaedic patients for depression and if medication can help treat it.
Who is the study for?
This trial is for adults over 18 who speak English or Spanish, have had an orthopaedic trauma surgery, and show signs of depression but aren't currently on antidepressants or have bipolar/psychotic disorders. They must score at least a 5 on the PHQ-9 questionnaire.Check my eligibility
What is being tested?
The study tests if prescribing Fluoxetine (an SSRI) or Duloxetine (an SNRI), compared to no medication, helps with depression in patients after orthopaedic trauma surgery. It looks at patient outcomes based on these treatments.See study design
What are the potential side effects?
Possible side effects include nausea, headache, sleep disturbances, sexual dysfunction for SSRIs like Fluoxetine; and dry mouth, fatigue, constipation for SNRIs like Duloxetine.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ year 1
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~year 1
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Depressive Symptom Scores
Secondary outcome measures
Adherence to Treatment Percentage
Healthcare Utilization - The number of hospitalizations and ED visits
Patient Reported Outcome Measures - Brief Pain Inventory Scores
+6 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: serotonin and norepinephrine reuptake inhibitors (SNRI)Experimental Treatment1 Intervention
Duloxetine, 30mg once daily
Group II: Selective serotonin reuptake inhibitors (SSRI)Experimental Treatment1 Intervention
Fluoxetine, 20mg once daily
Group III: ObservationalExperimental Treatment1 Intervention
Referral to behavioral health per standard practice and provision of resources for strategices to address depressive symptoms.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fluoxetine 20 MG
2021
N/A
~100
Duloxetine 30 MG
2021
Completed Phase 2
~330
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,240 Previous Clinical Trials
1,004,107 Total Patients Enrolled
33 Trials studying Depression
32,814 Patients Enrolled for Depression
Meghan K Wally, PhDPrincipal InvestigatorWake Forest University Health Sciences
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently on medication for depression.I am seeing an orthopedic trauma specialist for the first time for a broken limb or pelvis.I am 18 years old or older.I can communicate in English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Selective serotonin reuptake inhibitors (SSRI)
- Group 2: Observational
- Group 3: serotonin and norepinephrine reuptake inhibitors (SNRI)
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.
Are there any potential risks associated with utilizing Selective serotonin reuptake inhibitors (SSRI)?
"Due to its approval as a Phase 4 drug, Selective serotonin reuptake inhibitors (SSRI) earned a score of 3 in our team's safety assessment."
Answered by AI
Does this research study have any open enrollment slots for participants?
"This investigation, which was first posted to clinicaltrials.gov on August 1st 2023 and updated lastly on July 28th 2023, is not presently enrolling patients at this present time. Nonetheless, there are 1340 other studies that have open recruitment for potential participants."
Answered by AI
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