NCT03756246

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P25-P50 for phase_4 depression

Timeline
Completed

Started Jun 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 14, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 28, 2018

Completed
6 months until next milestone

Study Start

First participant enrolled

June 10, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2020

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

June 27, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

November 14, 2018

Last Update Submit

June 25, 2019

Conditions

DepressionHealthy

Keywords

depressionMajor Depressive Disorderdepressive

Outcome Measures

Primary Outcomes (1)

  • Positive and Negative Affect Schedules Score

    We will compute change in scores on the PANAS-x subscales between baseline and day 1. Self reported assessment that contains both positive and negative words and phrases that describe different feelings and emotions. Subjects read each item and mark the appropriate answer for how they feel right now as they fill out the form. Possible answers and the associated score are: (1) Not at all, (2) A little, (3) Moderately, (4) Quite a bit, (5) Extremely. To rate, responses to items in each scale are summed. The scales in the PANAS are listed below with the number of items in that scale in parentheses followed by the total range of the scale. General Dimensions Negative Affect (10) 10-50 General Dimensions of Positive Affect (10) 10-50 Negative Emotion Fear (6) 6-30 Hostility (6): 6-30 Guilt (6): 6-30 Sadness (5) 5- 25 Positive Emotion Joviality (8) 8-40 Self-Assurance (6) 6-30 Attentiveness (4) 4-20 Other Affective States Shyness (4) 4-20 Fatigue (4) 4-20 Serenity (3) 3-15

    1 Day

Secondary Outcomes (4)

  • Change in Cytokine Concentration (pg/mL)

    3 Days

  • Difference in PGE4/LipoxinA4 Ratio

    3 Days

  • Tryptophan Metabolites

    1 Day

  • HPA Axis

    3 Days

Other Outcomes (1)

  • Fold Change

    28 Days

Study Arms (2)

Depression Subjects: Influenza Vaccine

EXPERIMENTAL

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

Biological: Influenza Vaccine

Healthy Subjects: Influenza Vaccine

ACTIVE COMPARATOR

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

Biological: Influenza Vaccine

Interventions

Influenza VaccineBIOLOGICAL

The appropriate quadrivalent influenza vaccine for the give year will be given to subjects.

Also known as: flu shot, flu vaccine
Depression Subjects: Influenza VaccineHealthy Subjects: Influenza Vaccine

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults age 18-60
  • Able to provide written informed consent directly, without use of a proxy
  • Able to speak and write in English sufficiently to undergo consent and to complete self reports
  • Currently meets criteria for a Depressive Episode and a diagnosis of MDD according Mini International Neuropsychiatric Interview (MINI)
  • Depressive severity of ≥ 12 on the Quick Inventory of Depression Symptomatology, Clinician Rated (QIDS-C), corresponding to more than mild depression severity, but \<21, indicating not severe
  • No lifetime Axis I diagnosis on the MINI
  • QIDS-SR score \<6 indicating no depression
  • CRP at screening of \<1mg/L.

You may not qualify if:

  • Active, unstable, or serious medical illness (e.g. requiring urgent out-patient or higher level of care) as determined by history and lab examination at screening. For example, subjects with untreated cardiovascular disease (blood pressure above 140/80 on repeated measurements, history of cardiac event without medical follow up) or untreated diabetes (based on symptoms and elevated fasting blood sugar at screening) will be excluded.
  • Has received the influenza vaccine for the current season or within the last 12 months
  • Infection with fever or otherwise clinically significant in the last two weeks. Subjects with elevated white blood cell count at screening will also be excluded.
  • Current and within the last 3 months meeting criteria for tobacco use disorder.
  • Previous severe adverse event associated with IIV
  • History of allergy to any component of the IIV
  • History of Guillain-Barre Syndrome
  • Pregnancy
  • Otherwise judged unable to comply with study procedures or unsafe to participate by study clinician
  • Life-time history of mania, hypomania, or psychosis on the MINI
  • Meets or has met criteria for substance abuse or dependence in the last 6 months (3 months for nicotine)
  • Meets or has met criteria for any eating disorder in the last 6 months
  • Baseline suicidal ideation above "passive" defined as thoughts of death or dying (e.g. wish for natural death) without thoughts of active methods (e.g. overdose) or intent to die, as determined using the Concise Health Risk Tracking Scale (CHRT) (assessment interval "the last week") and clinician interview.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marisa Toups

Austin, Texas, 78701, United States

RECRUITING

MeSH Terms

Conditions

DepressionDepressive Disorder, Major

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Central Study Contacts

Project Coordinator

CONTACT

512-495-5595behavioral.immunology.lab@dellmed.utexas.edu

Maria Toups, M.D.

CONTACT

512-494-4672marisa.toups@austin.utexas.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Both healthy and depressed arms will receive the influenza vaccine.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2018

First Posted

November 28, 2018

Study Start

June 10, 2019

Primary Completion

May 1, 2020

Study Completion

May 1, 2021

Last Updated

June 27, 2019

Record last verified: 2019-06

Locations

US(1)