Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2026-02-23 @ 12:22 PM
Study NCT ID:
NCT02415166
Status:
TERMINATED
Last Update Posted:
2018-01-23
First Post:
2015-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Influenza Challenge in Mood Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007252', 'term': 'Influenza Vaccines'}], 'ancestors': [{'id': 'D014765', 'term': 'Viral Vaccines'}, {'id': 'D014612', 'term': 'Vaccines'}, {'id': 'D001688', 'term': 'Biological Products'}, {'id': 'D045424', 'term': 'Complex Mixtures'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jsavitz@laureateinstitute.org', 'phone': '918 502 5104', 'title': 'Jonathan Savitz', 'organization': 'LaurateInstitute'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': '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 tests. The study was terminated.'}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'VACCINE MDD', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'PLACEBO MDD', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'VACCINE HC', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'PLACEBO HC', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'THE TITER OF INFLUENZA ANTIBODIES', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VACCINE MDD', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG001', 'title': 'PLACEBO MDD', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}, {'id': 'OG002', 'title': 'VACCINE HC', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG003', 'title': 'PLACEBO HC', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}], 'timeFrame': 'ONE MONTH', 'description': 'Outcome data were not collected.\n\nThis 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.', 'reportingStatus': 'POSTED', 'populationDescription': 'Unmedicated outpatients with major depressive disorder. Outcome data not collected.'}, {'type': 'SECONDARY', 'title': 'THE INFLUENZA VIRUS-INDUCED PROLIFERATION OF CD4+ MEMORY T-CELLS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VACCINE MDD', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG001', 'title': 'PLACEBO MDD', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}, {'id': 'OG002', 'title': 'VACCINE HC', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG003', 'title': 'PLACEBO HC', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}], 'timeFrame': 'ONE MONTH', 'description': 'Data not collected.', 'reportingStatus': 'POSTED', 'populationDescription': 'Unmedicated participants with major depressive disorder. Data were not collected.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'IL-6 AND TNF PRODUCTION BY STIMULATED AND UNSTIMULATED MONOCYTE CELLS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VACCINE MDD', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG001', 'title': 'PLACEBO MDD', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}, {'id': 'OG002', 'title': 'VACCINE HC', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG003', 'title': 'PLACEBO HC', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}], 'timeFrame': '2 DAYS', 'reportingStatus': 'POSTED', 'populationDescription': 'Data not analyzed'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'DIFFERENCES IN RESTING STATE CEREBRAL BLOOD FLOW BETWEEN MDD AND HC GROUPS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VACCINE MDD', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG001', 'title': 'PLACEBO MDD', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}, {'id': 'OG002', 'title': 'VACCINE HC', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG003', 'title': 'PLACEBO HC', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}], 'timeFrame': '2 DAYS', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'DIAGNOSTIC GROUP DIFFERENCES IN THE BOLD RESPONSE (Using fMRI) TO MONETARY REWARDS IN THE VENTRAL STRIATUM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'VACCINE MDD', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG001', 'title': 'PLACEBO MDD', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}, {'id': 'OG002', 'title': 'VACCINE HC', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'OG003', 'title': 'PLACEBO HC', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}], 'timeFrame': '2 DAYS', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'VACCINE MDD', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'FG001', 'title': 'PLACEBO MDD', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}, {'id': 'FG002', 'title': 'VACCINE HC', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'FG003', 'title': 'PLACEBO HC', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was terminated after the recruitment of six participants'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'VACCINE MDD', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'BG001', 'title': 'PLACEBO MDD', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}, {'id': 'BG002', 'title': 'VACCINE HC', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.\n\nINFLUENZA VACCINE: THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER'}, {'id': 'BG003', 'title': 'PLACEBO HC', 'description': 'SALINE (0.5ML) DELIVERED I.M.\n\nNaCl-saline placebo: placebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '6', 'groupId': 'BG000'}, {'value': '35', 'spread': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-27', 'studyFirstSubmitDate': '2015-04-08', 'resultsFirstSubmitDate': '2017-04-28', 'studyFirstSubmitQcDate': '2015-04-13', 'lastUpdatePostDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-30', 'studyFirstPostDateStruct': {'date': '2015-04-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'IL-6 AND TNF PRODUCTION BY STIMULATED AND UNSTIMULATED MONOCYTE CELLS', 'timeFrame': '2 DAYS'}, {'measure': 'DIFFERENCES IN RESTING STATE CEREBRAL BLOOD FLOW BETWEEN MDD AND HC GROUPS', 'timeFrame': '2 DAYS'}, {'measure': 'DIAGNOSTIC GROUP DIFFERENCES IN THE BOLD RESPONSE (Using fMRI) TO MONETARY REWARDS IN THE VENTRAL STRIATUM', 'timeFrame': '2 DAYS'}], 'primaryOutcomes': [{'measure': 'THE TITER OF INFLUENZA ANTIBODIES', 'timeFrame': 'ONE MONTH', 'description': 'Outcome data were not collected.\n\nThis 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.'}], 'secondaryOutcomes': [{'measure': 'THE INFLUENZA VIRUS-INDUCED PROLIFERATION OF CD4+ MEMORY T-CELLS', 'timeFrame': 'ONE MONTH', 'description': 'Data not collected.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['MAJOR DEPRESSIVE DISORDER']}, 'referencesModule': {'references': [{'pmid': '17360153', 'type': 'BACKGROUND', 'citation': 'Irwin MR, Miller AH. Depressive disorders and immunity: 20 years of progress and discovery. Brain Behav Immun. 2007 May;21(4):374-83. doi: 10.1016/j.bbi.2007.01.010. Epub 2007 Mar 13.'}, {'pmid': '20955778', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '18073775', 'type': 'BACKGROUND', 'citation': "Dantzer R, O'Connor JC, Freund GG, Johnson RW, Kelley KW. From inflammation to sickness and depression: when the immune system subjugates the brain. Nat Rev Neurosci. 2008 Jan;9(1):46-56. doi: 10.1038/nrn2297."}, {'pmid': '19693001', 'type': 'BACKGROUND', 'citation': 'Price JL, Drevets WC. Neurocircuitry of mood disorders. Neuropsychopharmacology. 2010 Jan;35(1):192-216. doi: 10.1038/npp.2009.104.'}, {'pmid': '22420038', 'type': 'BACKGROUND', 'citation': 'Robinson OJ, Cools R, Carlisi CO, Sahakian BJ, Drevets WC. Ventral striatum response during reward and punishment reversal learning in unmedicated major depressive disorder. Am J Psychiatry. 2012 Feb;169(2):152-9. doi: 10.1176/appi.ajp.2011.11010137.'}, {'pmid': '19428491', 'type': 'BACKGROUND', 'citation': 'Savitz J, Drevets WC. Bipolar and major depressive disorder: neuroimaging the developmental-degenerative divide. Neurosci Biobehav Rev. 2009 May;33(5):699-771. doi: 10.1016/j.neubiorev.2009.01.004. Epub 2009 Jan 21.'}, {'pmid': '20719303', 'type': 'BACKGROUND', 'citation': 'Eisenberger NI, Berkman ET, Inagaki TK, Rameson LT, Mashal NM, Irwin MR. Inflammation-induced anhedonia: endotoxin reduces ventral striatum responses to reward. Biol Psychiatry. 2010 Oct 15;68(8):748-54. doi: 10.1016/j.biopsych.2010.06.010. Epub 2010 Aug 16.'}, {'pmid': '19423079', 'type': 'BACKGROUND', 'citation': 'Harrison NA, Brydon L, Walker C, Gray MA, Steptoe A, Critchley HD. Inflammation causes mood changes through alterations in subgenual cingulate activity and mesolimbic connectivity. Biol Psychiatry. 2009 Sep 1;66(5):407-14. doi: 10.1016/j.biopsych.2009.03.015. Epub 2009 May 7.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Psychological stress has been shown to impair the efficacy of the influenza vaccine, particularly in older individuals (\\> 60 years). However, the effect of depression (as opposed to stress per se) on vaccine response has not been measured, especially in younger people. One possible cause of this putative impaired vaccine response is suppression of the immune system in a subgroup of individuals with depression. Major depressive disorder (MDD) has been associated with a decline in total numbers of circulating B-cells, T-cells, and natural killer cells (NKC), a reduction in the proliferative responses of NKC and T-cells in vitro that is ameliorated by administration of selective serotonin reuptake inhibitors (SSRIs), increased susceptibility to various viral infections, and a decline in the efficacy of the herpes zoster vaccine in the elderly (1, 2). On the other hand, MDD appears also to be characterized by immunological abnormalities that manifest both as low-grade inflammation, including over-activity of the innate immune system (3). Whether inflammation and immune suppression are two different manifestations of the same underlying abnormality (unitary model) or whether inflammation and immune suppression are distinct phenomena occurring in different MDD subtypes (independent model) is not known.\n\nMDD is also characterized by neurophysiological abnormalities of striatal, cortical midline, and limbic brain structures that regulate hormonal, autonomic, and emotional responses to reward and stress (4-6). Yet, it remains unclear how immune function relates to these depression-associated functional neuroimaging abnormalities. Studies of healthy volunteers (HCs) administered endotoxin or the typhoid vaccine have reported inflammation-associated increases in negative affect along with neurophysiological changes in brain regions comprising the affective and reward circuitry (7-8). However, because these studies were limited to HCs, it is possible that the observed inflammation-induced neurophysiological changes were adaptive and therefore not applicable to MDD populations. That is, it remains unclear whether any experimentally-induced immune abnormalities in MDD are correlated and therefore potentially causally-related to the neuroimaging abnormalities observed in MDD.\n\nIn order to address these questions, we use a parallel group, placebo-controlled influenza vaccine challenge to induce transient inflammation that peaks 2-days post vaccination in MDD subjects and HCs. Subjects may complete a pre-and-post vaccination MRI scan, the latter during the peak inflammatory response.\n\nAim 1: To examine whether influenza vaccine effectiveness is compromised in a young-to-middle-aged sample (18-55 years of age) of individuals with MDD.\n\nHypothesis 1.1. Compared with HCs (n=40), individuals with MDD (n=40) will display reduced vaccine titers and reduced influenza virus-induced CD4+ memory T-cell proliferation four weeks post vaccination (T2).\n\nHypothesis 1.2. A greater number of MDD subjects than HCs will fail to show a four-fold increase in antibody titer, the conventional standard for determining a clinically significant response to a viral vaccine.\n\nAim 2: To test the competing models of immune dysfunction in MDD.\n\nHypothesis 2.1. At T0 and T1, stimulated and unstimulated monocytes from MDD subjects will show increased interleukin 6 (IL-6) and tumor necrosis factor (TNF) production compared with HCs. The effect will be most salient at T1 in individuals receiving vaccine.\n\nHypothesis 2.2. Consistent with the unitary model, monocyte IL-6 and/or TNF production at T0 and T1 will be inversely correlated with antibody titers at T2 in the MDD group.\n\nAim 3: To test for neurophysiological differences between MDD patients and HCs in resting state cerebral blood flow (with arterial spin labeling), resting EEG activity, and BOLD response to monetary rewards and interoceptive stimuli (with fMRI) at T0 and T1, and to correlate depression-associated perfusion, EEG activity, reward response, and interoceptive function with immune function at T0 and T1.\n\nHypothesis 3.1: Compared with HCs, the MDD subjects will display reduced perfusion of the subgenual anterior cingulate cortex (sgACC) and/or pregenual ACC (pgACC), hemispheric asymmetry in the alpha (8-13 Hz) power band (left prefrontal cortex hypoactivation), as well as reduced hemodynamic response to anticipatory reward in the ventral striatum. These differences will be most salient at T1 in the MDD group receiving vaccine versus the HCs receiving vaccine.\n\nHypothesis 3.2: The functional imaging abnormalities in the MDD group at T0 and/or T1 will be correlated with the abnormalities in monocyte activation in the MDD group at T0 and/or T1.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMajor 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.\n\nHealthy 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.\n\nExclusion Criteria:\n\nInability 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.\n\nSubjects 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).'}, 'identificationModule': {'nctId': 'NCT02415166', 'briefTitle': 'Influenza Challenge in Mood Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Laureate Institute for Brain Research, Inc.'}, 'officialTitle': 'Influenza Challenge in Mood Disorders', 'orgStudyIdInfo': {'id': 'LIBR # 2015-001-00'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'VACCINE MDD', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.', 'interventionNames': ['Biological: INFLUENZA VACCINE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO MDD', 'description': 'SALINE (0.5ML) DELIVERED I.M.', 'interventionNames': ['Other: NaCl-saline placebo']}, {'type': 'EXPERIMENTAL', 'label': 'VACCINE HC', 'description': 'SEASONAL INFLUENZA VACCINE (0.5ML) DELIVERED I.M.', 'interventionNames': ['Biological: INFLUENZA VACCINE']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'PLACEBO HC', 'description': 'SALINE (0.5ML) DELIVERED I.M.', 'interventionNames': ['Other: NaCl-saline placebo']}], 'interventions': [{'name': 'INFLUENZA VACCINE', 'type': 'BIOLOGICAL', 'description': 'THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER', 'armGroupLabels': ['VACCINE HC', 'VACCINE MDD']}, {'name': 'NaCl-saline placebo', 'type': 'OTHER', 'description': 'placebo', 'armGroupLabels': ['PLACEBO HC', 'PLACEBO MDD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74136', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Laureate Institute for Brian Research', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Jonathan B Savitz, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laureate Institute for Brain Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laureate Institute for Brain Research, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}