Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections

N/AActive Not RecruitingNCT06945627

Sara Poletti408,551 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

408,551

Conditions

Severe Mental Illness Inflammation Viral Infections Mood Disorders Schizophrenia

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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),

Locations (4)

University of Antwerp

Antwerp, Belgium, Belgium

University of Haifa

Haifa, Israel, Israel

IRCCS Ospedale San Raffaele

Milan, Italy, Italy

University of Oslo

Oslo, Norway, Norway

Outcomes

Primary Outcomes

number of hospital admission for mental illness after infection diagnosis

number of onset or relapse of mental illness following infection

Time frame: 3 years

number of infections (Pathogen Burden Summary - PBS) in patients with mental illness

number of samples positive for antibodies for viruses associated with Mental illness in the literature (IgG, expressed as AU/mL)

Time frame: 3 years

Secondary Outcomes

Environmental risk and resilience factors for mental illness and severe outcomes

socio-economic socio-demographic variables inflammatory markers levels, timing and type of infection,

Time frame: 3 years

Neurobiological risk and resilience factors for mental illnesses and severe outcomes

differentially expressed gene between patients with high vs low Pathogen Burden Summary (PBS) with or without mental illness

Time frame: 3 years

Predictive risk models based on an individual biological and environmental signatures

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

Time frame: 3 years

genes or proteins that might be modified using drugs

target genes involved in severe and post-infectious MI.

Time frame: 3 years