Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections (VIRAL-MI)

May 9, 2025 updated by: Sara Poletti

Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections: Translating Epidemiology to Deep-phenotyping

This observational study aims to identify the underlying neurobiological and environmental mechanisms that influence vulnerability or resilience to mental illness in the context of infection and their contribution to severe infective outcomes in people with pre-existing mental illness. The main questions it aims to answer are:

  • How do viral infections influence the development of mental illness?
  • What neurobiological and environmental factors contribute to influence the development of mental illness following infection?
  • How do these factors relate to the severity of infectious illness in people with pre-existing mental disorders?

Researchers will move from large population databases to well-defined, deeply characterised samples to explore the association between infection and subsequent mental health outcomes, and the biological mechanisms behind these changes.

Participants's data has already been collected.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

408551

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerp, Belgium, 2570
        • University of Antwerp
  • Israel
      • Haifa, Israel, 3498838
        • University of Haifa
  • Italy
      • Milan, Italy, 20132
        • Irccs Ospedale San Raffaele
  • Norway
      • Oslo, Norway, 0424
        • University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with major depressive disorder or bipolar disorder (MOOD-MI cohort) and patients with COVID-19 (COVID-MI cohort). For epidemiological cohorts (MoBa, TOP, CHS) any patients with severe mental illnesses

Description

Inclusion Criteria for the MOOD-MI cohort:

  • A depressive episode according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria in the course of MDD or BD with:

    • HDRS score > 17
    • Age 18-65 years;
  • Signed informed consent, able to understand, speak and write the national language

Inclusion Criteria for the COVID-MI cohort:

  • Having a positive nasopharyngeal swab for COVID-19 in the last 36 months;
  • Age between 18-25 years;
  • Signed informed consent, able to understand, speak and write the national language

Exclusion Criteria for the MOOD-MI cohort:

  • History of schizophrenia, schizoaffective disorder, psychosis not otherwise specified; anorexia or bulimia nervosa;
  • Taking following medications: antipsychotics, anticonvulsants, mood stabilizers; stimulants
  • Active infection requiring antibiotics therapy;
  • Immunosuppressed patient or other chronic diseases
  • Signs of active infection requiring treatment
  • Use of anti-inflammatory medication on a regular basis for a chronic inflammatory/autoimmune Disorder. Forbidden treatment: corticosteroids, Non Steroidal Anti-inflammatory Drugs, immunosuppressant IV-Ig based treatment
  • Ongoing fever, infection treated by antibiotics or uncontrolled diabetes type I or II;
  • Existing cancer or history of cancer in the last 5 years (except skin epidermoid cancer or in-situ cervix cancer);
  • Known HIV infection or clinically manifest Acquired Immune Deficiency Syndrome (AIDS), Parkinson's or Alzheimer's disease, or any other serious condition likely to interfere e with the conduct of the trial;
  • Abuse of drugs or alcohol in the past 6 months

Exclusion Criteria for the COVID-MI cohort:

  • Comorbidity for psychotic disorders, verified by SCID-CV;
  • Current and clinically significant substance use disorder;
  • Current comorbidity with neurological conditions or severe head trauma, general brain disorder preceding the emergence of PASC, including microhaemorrhages and/or ischaemia occurring during the acute phase of COVID;
  • Neuropsychological diagnosis of intellectual disability;
  • Presence of contraindications to blood sampling and/or MRI;
  • Pregnancy status at the time of recruitment.

Other exclusion criteria related to the MRI procedure include:

  • Aneurysm clip
  • Implanted neural stimulator
  • Implanted cardiac pacemaker or auto-defibrillator
  • Cochlear implant
  • Ocular foreign body (e.g., metal shavings)
  • Any implanted device (pumps, infusion devices, etc)
  • Shrapnel injuries.

For epidemiological cohorts (MoBa, TOP, CHS) age between 18 and 65 ya, diagnosis of a severe mental illness (Schizophrenia, Major Depression, Bipolar disorder, anxiety disorders),

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Trans-D
Other: This research doesn't involve any kind of intervention on the study participants
This research doesn't involve any kind of intervention on the study participants
Cov-N-Psy
Other: This research doesn't involve any kind of intervention on the study participants
This research doesn't involve any kind of intervention on the study participants
CHS1
Other: This research doesn't involve any kind of intervention on the study participants
This research doesn't involve any kind of intervention on the study participants
CHS2
Other: This research doesn't involve any kind of intervention on the study participants
This research doesn't involve any kind of intervention on the study participants
MOOD-MI
Other: This research doesn't involve any kind of intervention on the study participants
This research doesn't involve any kind of intervention on the study participants
COVID-MI
Other: This research doesn't involve any kind of intervention on the study participants
This research doesn't involve any kind of intervention on the study participants
MoBa
Other: This research doesn't involve any kind of intervention on the study participants
This research doesn't involve any kind of intervention on the study participants
TOP
Other: This research doesn't involve any kind of intervention on the study participants
This research doesn't involve any kind of intervention on the study participants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of hospital admission for mental illness after infection diagnosis
Time Frame: 3 years
number of onset or relapse of mental illness following infection
3 years
number of infections (Pathogen Burden Summary - PBS) in patients with mental illness
Time Frame: 3 years
number of samples positive for antibodies for viruses associated with Mental illness in the literature (IgG, expressed as AU/mL)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neurobiological risk and resilience factors for mental illnesses and severe outcomes
Time Frame: 3 years
differentially expressed gene between patients with high vs low Pathogen Burden Summary (PBS) with or without mental illness
3 years
Predictive risk models based on an individual biological and environmental signatures
Time Frame: 3 years

stratification of patients in risk and resilence clusters using unsupervised machine learning algorithms based on

  • history of infection
  • plasmatic concentrations of immune analytes;
  • metabolites of the kynurenine pathway;
  • Polygenic Risk Scores;
  • gene expression;
  • measures of brain structure
  • measures of early and recent stress
3 years
Environmental risk and resilience factors for mental illness and severe outcomes
Time Frame: 3 years
socio-economic socio-demographic variables inflammatory markers levels, timing and type of infection,
3 years
genes or proteins that might be modified using drugs
Time Frame: 3 years
target genes involved in severe and post-infectious MI.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sara Poletti

Investigators

  • Principal Investigator: Sara Poletti, PhD, Irccs Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 2, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

April 9, 2025

First Submitted That Met QC Criteria

April 18, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 9, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ERP-2023-23684210

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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