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Impact of Immune Challenge on Triple Network Connectivity in Humans

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02653235
Recruitment Status : Unknown
Verified January 2016 by NHS Greater Glasgow and Clyde.
Recruitment status was:  Not yet recruiting
First Posted : January 12, 2016
Last Update Posted : January 12, 2016
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

Brief Summary:

Acquiring, processing and utilising "information" is crucial to any mental function -including seemingly simple daily functions. Collectively called 'cognitive functions', these processes are a result of different regions of the brain acting together.

Disruption of these cognitive functions increases the risk of development of mental health problem. Recently it has been proposed that inflammatory pathways may contribute to disorders of cognition and behaviour like depression.

This is largely due to research showing that those with inflammatory conditions like arthritis are more likely to develop mental health problems like depression. Conversely, those who suffer from mental health problems (even in the absence of inflammatory conditions) have large amounts of inflammatory molecules in the blood. Studies in animals suggest that inflammation outside the brain can reach and affect the brain in a number of ways. So, does inflammation play a role in the development of cognitive and behavioural symptoms? What are the pathways involved?

The current project tries to address this question. Specifically, the investigators intend to use modern scanning techniques to examine the effect of inducing a low grade inflammation (using a commonly used typhoid vaccine) to see how the inflammation affects how different regions of the act together to perform cognitive functions.

Condition or disease Intervention/treatment Phase
Major Depression Biological: Salmonella typhi vaccination Biological: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Exploring the Impact of Peripheral Immune Challenge on the "Triple Network" and "Dorsal Nexus" Functional Connectivity in Humans
Study Start Date : January 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : January 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Arm Intervention/treatment
Active Comparator: Typhoid vaccination
Salmonella typhi vaccination
Biological: Salmonella typhi vaccination
Placebo Comparator: Placebo
0.9% sodium chloride
Biological: Placebo

Primary Outcome Measures :
  1. Functional connectivity measured using resting state functional MRI BOLD time series cross correlations between the network nodes. [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Correlation of functional connectivity measures with circulating serum cytokines and POMS/ BDI scores using multivariate general linear models [ Time Frame: 6 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Written informed consent
  2. Aged 18 - 50 years old
  3. Male

Exclusion Criteria:

  1. Female
  2. History/family history of medical or/and Axis I DSM IV condition
  3. Received typhoid vaccination within the last 3 years
  4. Taken oral antibiotics/antiinflammatory agents within the previous 2 weeks
  5. Current Smokers
  6. Contraindication for MRI scans
  7. Contraindication for Salmonella typhi vaccination
  8. Known hypersensitivity to a Vi antigen containing vaccine.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02653235

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Contact: Rajeev Krishnadas, MBBS, MRCPsych, MD, PhD rajeev.krishnadas@glasgow.ac.uk

Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT02653235    
Other Study ID Numbers: GN14NE490
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: January 12, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Depressive Disorder, Major
Depressive Disorder
Mood Disorders
Mental Disorders