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Active, Not Recruiting

NCT Number: NCT06945627

Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Severe Mental Illness Infections Inflammation Mental Disorders Mood Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Viral Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Antwerp, Antwerp, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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),

Treatment and study plan

This research doesn't involve any kind of intervention on the study participants

Other

This research doesn't involve any kind of intervention on the study participants

Primary outcomes

  1. number of hospital admission for mental illness after infection diagnosis

    Time frame: 3 years

    number of onset or relapse of mental illness following infection

  2. 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)

Secondary outcomes

  1. 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,

  2. 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. 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

  4. genes or proteins that might be modified using drugs

    Time frame: 3 years

    target genes involved in severe and post-infectious MI.

Sponsors and collaborators

Lead sponsor

Sara Poletti

Other

Registry information

Official study title

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

Acronym: VIRAL-MI

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Apr 25, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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