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Depression Subjects: Influenza Vaccine for Depression

Phase 4
Waitlist Available
Research Sponsored by University of Texas at Austin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

The purpose of this study is to determine differences between the immune responses in healthy and depressed people. Participants will receive the influenza vaccine and their responses will be monitored. This study will recruit 15 healthy and 60 depressed participants.

Eligible Conditions
  • Depression
  • Healthy Subjects

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Positive and Negative Affect Schedules Score
Secondary study objectives
Cytokine
Difference in PGE4/LipoxinA4 Ratio
HPA Axis
+1 more
Other study objectives
Fold Change

Side effects data

From 2015 Phase 4 trial • 985 Patients • NCT02290691
64%
Tenderness
48%
Pain
35%
Redness
29%
Swelling
24%
Itching
20%
Muscle Ache
15%
Headache
12%
Fatigue
10%
Bruising
5%
Chills
4%
Nausea
1%
Fever
1%
Vomiting
100%
80%
60%
40%
20%
0%
Study treatment Arm
Needle- Free
Needle and Syringe

Awards & Highlights

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.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Depression Subjects: Influenza VaccineExperimental Treatment1 Intervention
Subjects will receive a quadrivalent inactivated influenza vaccine, for the appropriate season/year of enrollment. The vaccine will be administered by the PI or similarly trained clinician, into the deltoid muscle as directed
Group II: Healthy Subjects: Influenza VaccineActive Control1 Intervention
Subjects will receive a quadrivalent inactivated influenza vaccine, for the appropriate season/year of enrollment. The vaccine will be administered by the PI or similarly trained clinician, into the deltoid muscle as directed
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Influenza Vaccine
2022
Completed Phase 4
~16570

Find a Location

Who is running the clinical trial?

University of Texas at AustinLead Sponsor
374 Previous Clinical Trials
86,100 Total Patients Enrolled
33 Trials studying Depression
5,247 Patients Enrolled for Depression
~12 spots leftby Nov 2025