Recruiting

Influenza Vaccine

Sponsor:

University of Texas at Austin

Code:

NCT03756246

Conditions

Depression

Healthy

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Interventions

Influenza Vaccine

Study Details

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.

Conditions

Depression

Healthy

Study ID

NCT03756246

Start date

Jun 10, 2019

Status verified date

Jun, 2019

Completion date

May, 2021

Anticipated

Primary completion date

May, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Accepted

Inclusion Criteria:

Inclusion Criteria for all subjects

  • 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

Inclusion Criteria for depressed subjects

  • 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

Inclusion Criteria for healthy Subjects

  • No lifetime Axis I diagnosis on the MINI
  • QIDS-SR score <6 indicating no depression
  • CRP at screening of <1mg/L.

Exclusion Criteria:

Exclusion Criteria for all subjects

  • 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.
  • Taking medications that have a significant effect on the immune system. This includes daily Non-steroidal Anti-inflammatory medications (NSAIDs). As needed NSAIDs will not be exclusionary but subjects will be asked to refrain from NSAID usage for 48 hours prior to the vaccination visit and through the day 3 visit.
  • 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

Exclusion Criteria for Depressed Subjects

  • 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.

No Exclusion Criteria for Healthy Subjects

Study Design

Enrollment

75 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Depression Subjects: Influenza Vaccine

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

active comparator: Healthy Subjects: Influenza Vaccine

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

Interventions

Influenza Vaccine

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

Primary outcome measure

  • Positive and Negative Affect Schedules Score [ Time Frame: 1 Day ]

Central Contacts and Locations

Locations

Marisa Toups

Recruiting

Austin, Texas, United States, 78701

Contacts

Principal Investigator:

Marisa Toups, MD

More Information

Sponsor

University of Texas at Austin

Last update posted

Jun 27, 2019

Last verified

Jun, 2019

Keywords

  • depression
  • Major Depressive Disorder
  • depressive

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas at Austin on 2019-06-27.