Depression, Healthy
Conditions
Keywords
depression, Major Depressive Disorder, depressive
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.
Detailed description
The purpose of this study is to determine differences between the immune responses in healthy and depressed people. Specifically subjects are provided a mild immune stimulus, an influenza vaccine, and their responses are monitored. The goals are to determine whether patients with depression experience a temporary worsening of mood in response to the stimulus and whether this is associated with measurable differences in the cytokine response to the vaccine. Additionally, patients with depression may be less likely to mount a successful antibody response to vaccination as healthy people based on circumstantial evidence, and this study will assess whether this the case. This study aims to recruit a sample of 15 healthy and 60 depressed participants. The 15 healthy participants will be age and gender matched to the first 15 depressed participants recruited. Three more sets of age and gender matched depressed subjects will be recruited. This will result in 15 sets of quintuplets (4 depressed and one healthy), that are matched by age and gender. The study consists of four visits. The first visit is the baseline assessment where participants will receive the influenza vaccine. Participants will then return 1, 3 and 28 days after receiving the vaccine to assess their responses.
Interventions
BIOLOGICALInfluenza Vaccine
The appropriate quadrivalent influenza vaccine for the give year will be given to subjects.
Sponsors
University of Texas at Austin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Both healthy and depressed arms will receive the influenza vaccine.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Affect Schedules Score | 1 Day | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cytokine Concentration (pg/mL) | 3 Days | We will compute differences in cytokine (IFN- α, IFN-y, IL-6, IL1-β and TNF-α) values for each subject between baseline and day 1 and days 1 and 3. Using OLS regression we will compute regressions between hypothesis appropriate time points using baseline CRP, QIDS, PANAS score and BMI as covariates. |
| Difference in PGE4/LipoxinA4 Ratio | 3 Days | After determining the difference in the PGE4/LipoxinA4 ratio between days 1 and 3, we will perform a similar regression. |
| Tryptophan Metabolites | 1 Day | We will calculate difference between baseline and day 1 in the KYN/TRP and KYNA/QUIN ratios and us them in regression models as above, correcting for two tests. |
| HPA Axis | 3 Days | To test the hypothesis that ACTH/cortisol affects peak inflammatory cytokine levels in MDD, we will use similar OLS regression models including HPA-axis response as a covariate and examining its interaction with cytokines as the dependent variables. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Fold Change | 28 Days | : Fold change from pre- to 28 days post-vaccine will be calculated for each of the three influenza strains targeted by the vaccine. Fold change \> 4 to any one of the three strains will be considered success. Proportion of successful vaccination will be compared between HC and MDD using a linear model adjusted for age and pre-vaccination titer, which have been shown to affect antibody response. |
Countries
United States
Contacts
Primary ContactProject Coordinator
Backup ContactMaria Toups, M.D.
Outcome results
None listed