Impact of Immune Challenge on Triple Network Connectivity in Humans
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|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
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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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|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|
Active Comparator: Typhoid vaccination
Salmonella typhi vaccination
Biological: Salmonella typhi vaccination
Placebo Comparator: Placebo
0.9% sodium chloride
- Functional connectivity measured using resting state functional MRI BOLD time series cross correlations between the network nodes. [ Time Frame: 6 hours ]
- 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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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||Male|
|Accepts Healthy Volunteers:||Yes|
- Written informed consent
- Aged 18 - 50 years old
- History/family history of medical or/and Axis I DSM IV condition
- Received typhoid vaccination within the last 3 years
- Taken oral antibiotics/antiinflammatory agents within the previous 2 weeks
- Current Smokers
- Contraindication for MRI scans
- Contraindication for Salmonella typhi vaccination
- Known hypersensitivity to a Vi antigen containing vaccine.
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
|Contact: Rajeev Krishnadas, MBBS, MRCPsych, MD, PhDfirstname.lastname@example.org|
|Responsible Party:||NHS Greater Glasgow and Clyde|
|Other Study ID Numbers:||
|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|
Depressive Disorder, Major