NCT02653235

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 12, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 12, 2016

Status Verified

January 1, 2016

Enrollment Period

8 months

First QC Date

January 7, 2016

Last Update Submit

January 8, 2016

Conditions

Major Depression

Outcome Measures

Primary Outcomes (1)

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

    6 hours

Secondary Outcomes (1)

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

    6 hours

Study Arms (2)

Typhoid vaccination

ACTIVE COMPARATOR

Salmonella typhi vaccination

Biological: Salmonella typhi vaccination

Placebo

PLACEBO COMPARATOR

0.9% sodium chloride

Biological: Placebo

Interventions

Salmonella typhi vaccinationBIOLOGICAL
Typhoid vaccination
PlaceboBIOLOGICAL
Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Written informed consent
  • Aged 18 - 50 years old
  • Male

You may not qualify if:

  • Female
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 32532687DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Central Study Contacts

Rajeev Krishnadas, MBBS, MRCPsych, MD, PhD

CONTACT

rajeev.krishnadas@glasgow.ac.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 12, 2016

Study Start

January 1, 2016

Primary Completion

September 1, 2016

Study Completion

January 1, 2017

Last Updated

January 12, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share