CClinicalTrials.gg
Status unknownNCT02653235Updated Jan 12, 2016

Impact of Immune Challenge on Triple Network Connectivity in Humans

An interventional study of Salmonella typhi vaccination and Placebo in Major Depression, sponsored by NHS Greater Glasgow and Clyde. Status unknown. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-01-12.

Sponsored by NHS Greater Glasgow and Clyde · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Jan 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

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Conditions studied

  • Major Depression
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In context

Depressive Disorder, Major

2,741 studies on the registry are indexed under Depressive Disorder, Major; 558 are open to participants now.

This study's planned enrollment of 20 is below the median of 80 across 2,282 interventional studies indexed under Depressive Disorder, Major.

Browse Depressive Disorder, Major studies →

Lead sponsor

NHS Greater Glasgow and Clyde is the lead sponsor of 215 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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.
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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
20 participants (estimated)

Study arms

  • Active comparator
    Typhoid vaccination

    Salmonella typhi vaccination

    Biological: Salmonella typhi vaccination

  • Placebo comparator
    Placebo

    0.9% sodium chloride

    Biological: Placebo

Interventions

  • BiologicalSalmonella typhi vaccination
  • BiologicalPlacebo
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What researchers measure

Primary outcomes

  1. Functional connectivity measured using resting state functional MRI BOLD time series cross correlations between the network nodes.

    Time frame: 6 hours

Secondary outcomes

  1. Correlation of functional connectivity measures with circulating serum cytokines and POMS/ BDI scores using multivariate general linear models

    Time frame: 6 hours

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Stefanov K, McLean J, McColl A, Basu N, Cavanagh J, Krishnadas R. Mild Inflammation in Healthy Males Induces Fatigue Mediated by Changes in Effective Connectivity Within the Insula. Biol Psychiatry Cogn Neurosci Neuroimaging. 2020 Sep;5(9):865-874. doi: 10.1016/j.bpsc.2020.04.005. Epub 2020 Apr 22. PubMed 32532687 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 12, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02653235
Lead sponsor
NHS Greater Glasgow and Clyde
Collaborators
University of Glasgow
Responsible party
Sponsor
First posted
Jan 12, 2016
Start date
Jan 2016
Primary completion
Sep 2016 (estimated)
Completion
Jan 2017 (estimated)
Last update
Jan 12, 2016

Study contacts

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

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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