Major DepressionNCT02653235
Impact of Immune Challenge on Triple Network Connectivity in Humans
A study testing Salmonella typhi vaccination in people with Major Depression, run by NHS Greater Glasgow and Clyde.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Major Depression
- What is being tested?
- Salmonella typhi vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Written informed consent
- Aged 18 - 50 years old
- Male
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
Rajeev Krishnadas, MBBS, MRCPsych, MD, PhD contact
About this study
Official title: Exploring the Impact of Peripheral Immune Challenge on the "Triple Network" and "Dorsal Nexus" Functional Connectivity in Humans
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.
Read more
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.
- Conditions
- Major Depression
- Being tested
- Salmonella typhi vaccination, Placebo
- Medical subject headings
- Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salmonella typhi vaccinationBiological
PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| Typhoid vaccination | Active comparator | Salmonella typhi vaccination Receives: Biological: Salmonella typhi vaccination |
| Placebo | Placebo comparator | 0.9% sodium chloride Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional connectivity measured using resting state functional MRI BOLD time series cross correlations between the network nodes.
Measured: 6 hours
Secondary outcomes (1)
Correlation of functional connectivity measures with circulating serum cytokines and POMS/ BDI scores using multivariate general linear models
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionSep 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NHS Greater Glasgow and Clyde
- Sponsor type
- University, hospital or other
- Collaborators
- University of Glasgow
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02653235
- Sponsor's protocol ID
- GN14NE490
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 12 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Impact of Peripheral Immune Challenge on the "Triple Network" and "Dorsal Nexus" Functional Connectivity in Humans
- ClinicalTrials.gov ID
- NCT02653235
- Acronym / sponsor ID
- GN14NE490
- Conditions
- Major Depression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- NHS Greater Glasgow and ClydeUniversity, hospital or other
- Collaborators
- University of Glasgow
- Study start
- Jan 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 12 Jan 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Typhoid vaccination | Active comparator | Biological: Salmonella typhi vaccinationSalmonella typhi vaccination |
| Placebo | Placebo comparator | Biological: Placebo0.9% sodium chloride |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Written informed consent
- Aged 18 - 50 years old
- Male
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Salmonella typhi vaccination | Biological | Typhoid vaccination |
| Placebo | Biological | Placebo |
Primary outcome
Functional connectivity measured using resting state functional MRI BOLD time series cross correlations between the network nodes.
Time frame: 6 hours
1 secondary outcome
Correlation of functional connectivity measures with circulating serum cytokines and POMS/ BDI scores using multivariate general linear models
Time frame: 6 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2016.
- Derived from this study: PubMed 32532687Stefanov 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajeev Krishnadas, MBBS, MRCPsych, MD, PhD contact
Questions about this trial
What is this clinical trial studying?
A study testing Salmonella typhi vaccination in people with Major Depression, run by NHS Greater Glasgow and Clyde.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rajeev Krishnadas, MBBS, MRCPsych, MD, PhD (rajeev.krishnadas@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional connectivity measured using resting state functional MRI BOLD time series cross correlations between the network nodes. (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02653235, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2016.