Impact of Immune Challenge on Triple Network Connectivity in Humans

Major Depression Clinical Trial

Official title:

Exploring the Impact of Peripheral Immune Challenge on the "Triple Network" and "Dorsal Nexus" Functional Connectivity in Humans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02653235
• Other study ID #: GN14NE490
• Status: Not yet recruiting
• Phase: N/A
• First received: January 7, 2016
• Last updated: January 8, 2016
• Start date: January 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2016
• Source: NHS Greater Glasgow and Clyde
• Contact: Rajeev Krishnadas, MBBS, MRCPsych, MD, PhD
• Email: rajeev.krishnadas[@]glasgow.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Depressive Disorder, Major
• Major Depression

Intervention

Biological:
• Salmonella typhi vaccination

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde	University of Glasgow

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional connectivity measured using resting state functional MRI BOLD time series cross correlations between the network nodes.		6 hours	No
Secondary	Correlation of functional connectivity measures with circulating serum cytokines and POMS/ BDI scores using multivariate general linear models		6 hours	No