MAJOR DEPRESSIVE DISORDER Clinical Trial
Official title:
Influenza Challenge in Mood Disorders
Verified date | December 2017 |
Source | Laureate Institute for Brain Research, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this project is to evaluate the efficacy of the influenza vaccine in individuals with major depressive disorder (MDD) as well as to elucidate the nature of the immunological abnormalities in MDD using a quasi-experimental design. Specifically, the investigators plan to induce transient, mild inflammation in medically-healthy study participants using the influenza vaccine. Initially the investigators will conduct a pilot project with up to 20 individuals in order to evaluate the time-point at which the peak inflammatory response to the vaccine occurs. Subjects will receive the seasonal influenza vaccine and provide blood samples 4 hours, 2 days, and 30 days post vaccination. Subsequent to the pilot study, both depressed and psychiatrically-healthy participants will be randomized in a parallel group, double-blind design so that they receive either influenza vaccine (seasonal vaccine) or saline (i.m). At baseline, subjects will provide a blood sample, complete a number of rating scales to measure mood and fatigue, and may complete approximately one hour of MRI scanning with or without simultaneous EEG recording. Two-days post vaccination, they will provide a second blood sample, complete more clinical ratings and may complete another identical MRI session with or without simultaneous EEG. Four weeks later, participants will be asked to return to provide a third blood sample and complete additional clinical ratings. The blood samples will be used to measure both innate and adaptive immune function and may be used to correlate the vaccine-induced immunological changes to neurophysiological changes in the brain measured by MRI and/or EEG.
Status | Terminated |
Enrollment | 6 |
Est. completion date | March 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: Major Depressive Disorder Patient Group - Currently Depressed: Subjects will have met Diagnostic and Statistical Manual of the American Psychiatric Association (DSM-V) criteria for primary MDD in a current major depressive episode and current Hamilton Depression Rating Scale (HAM-D) or Montgomery Asberg Depression Rating Scale (MADRS) score in the mild-to-severely depressed range and will have been deemed to be medically stable by a physician listed on this protocol. Subjects who do not wish to receive treatment with psychotropic medication in the future and have not taken psychotropic medication for at least 3 weeks will be included in the study. Healthy Comparison Group: Subjects will be selected who have not met criteria for any Axis I psychiatric disorder, have no known first-degree relatives with mood or anxiety disorders, and have a current score on the HAM-D or MADRS in the non-depressed range. Exclusion Criteria: Inability to provide informed consent, pregnant or nursing women, known hypersensitivity to vaccines, age of onset of MDD > 40 years, metal implants or other factors that would preclude MRI scanning, serious risk of suicide, delusions or hallucinations, medical or neurological illnesses (such as diabetes, autoimmune disorders or inflammatory bowel disease) that affect brain structure, function or immune measurements, previous head injury with loss of consciousness, abuse of drugs or alcohol within the previous year or a lifetime history of substance dependence, treatment with medications that impact immune function (e.g. prednisone), HIV or other chronic infection, a recent acute illness (e.g. influenza), receipt of a vaccine within 3 months of commencing the study. Subjects whose first major depressive episodes arose temporally after other major medical or psychiatric conditions will also be excluded, since their functional imaging results generally differ from those reported in primary MDD. Subjects will be asked not to take any over-the-counter non-steroidal anti-inflammatory drugs or drink alcohol for 48 hr. before each study day. The use of oral contraceptives and menstrual phase or status are not exclusion criteria but this information will be recorded. The same exclusion criteria apply to healthy controls with the added criterion that first-degree relatives should be free of major psychiatric illness as assessed with the Family Interview for Genetic Studies (FIGS). |
Country | Name | City | State |
---|---|---|---|
United States | Laureate Institute for Brian Research | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Laureate Institute for Brain Research, Inc. |
United States,
Blume J, Douglas SD, Evans DL. Immune suppression and immune activation in depression. Brain Behav Immun. 2011 Feb;25(2):221-9. doi: 10.1016/j.bbi.2010.10.008. Epub 2010 Oct 16. Review. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | IL-6 AND TNF PRODUCTION BY STIMULATED AND UNSTIMULATED MONOCYTE CELLS | 2 DAYS | ||
Other | DIFFERENCES IN RESTING STATE CEREBRAL BLOOD FLOW BETWEEN MDD AND HC GROUPS | 2 DAYS | ||
Other | DIAGNOSTIC GROUP DIFFERENCES IN THE BOLD RESPONSE (Using fMRI) TO MONETARY REWARDS IN THE VENTRAL STRIATUM | 2 DAYS | ||
Primary | THE TITER OF INFLUENZA ANTIBODIES | Outcome data were not collected. This was a failed study as all participants, including those who were putatively vaccine-naive had antibodies to influenza at baseline and therefore the original hypothesis could not be tested. The study was terminated. |
ONE MONTH | |
Secondary | THE INFLUENZA VIRUS-INDUCED PROLIFERATION OF CD4+ MEMORY T-CELLS | Data not collected. | ONE MONTH |
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