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NCT06945627Active, not recruiting

Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections

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

Source: ClinicalTrials.gov · Last updated 5 Nov 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
408551 (actual)
First submitted
9 Apr 2025
Start date
2 May 2024
Primary completion date
2 May 2026
Lead sponsor
Sara Poletti
NCT number
NCT06945627

What you commit to

  • Study type: Observational
  • Participants enrolled: 408551
  • From 2 May 2024 to the primary completion date, 2 May 2026
  • 4 sites in 4 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Taking following medications: antipsychotics, anticonvulsants, mood stabilizers; stimulants
  • Abuse of drugs or alcohol in the past 6 months
  • Cochlear implant

Other illness

  • History of schizophrenia, schizoaffective disorder, psychosis not otherwise specified; anorexia or bulimia nervosa;
  • 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;
  • 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;
  • Implanted cardiac pacemaker or auto-defibrillator

Age

  • 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),

Other

  • 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
  • Ocular foreign body (e.g., metal shavings)
  • Any implanted device (pumps, infusion devices, etc)

Who the study is looking for

  • 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
  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Antwerp
Coordinator of this site? Confirm its status
AntwerpBelgiumUnknown status
University of Haifa
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyUnknown status
University of Oslo
Coordinator of this site? Confirm its status
OsloNorwayUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.