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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
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial

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.
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.
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 weeks
Treatment ~ Varies
Follow Up ~year 1
This trial's timeline: 3 weeks for screening, Varies for treatment, 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
Depressive Symptom Scores
Secondary study objectives
Adherence to Treatment Percentage
Healthcare Utilization - The number of hospitalizations and ED visits
Patient Reported Outcome Measures - Brief Pain Inventory Scores
+6 more

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

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
Duloxetine 30 MG
2021
Completed Phase 2
~330
Fluoxetine 20 MG
2021
N/A
~100

Find a Location

Who is running the clinical trial?

Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,459,936 Total Patients Enrolled
38 Trials studying Depression
35,926 Patients Enrolled for Depression
Meghan K Wally, PhDPrincipal InvestigatorWake Forest University Health Sciences

Media Library

Duloxetine (Serotonin and norepinephrine reuptake inhibitors (SNRI)) Clinical Trial Eligibility Overview. Trial Name: NCT05976347 — Phase 4
Depression Research Study Groups: Selective serotonin reuptake inhibitors (SSRI), Observational, serotonin and norepinephrine reuptake inhibitors (SNRI)
Depression Clinical Trial 2023: Duloxetine Highlights & Side Effects. Trial Name: NCT05976347 — Phase 4
Duloxetine (Serotonin and norepinephrine reuptake inhibitors (SNRI)) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05976347 — Phase 4
~67 spots leftby Dec 2025
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