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

NCT07453420 | Active Not Recruiting

• 2 other identifiers: VIRAL-MINEURON_RV-086
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

Brief Summary

The study protocol was submitted to ERA-NET NEURON for funding on 28/06/2023. Description of the Israeli responsibilities was extracted from the full submitted research protocol. The protocol includes two studies (CHS1 and CHS2). At the time of the study registration CHS1 was partially analyzed whereas CHS2 has not been initiated. See below the full description of the two studies' protocols. To explore the probability of mental illness (MI) onset or psychiatric relapse following infections, we will utilize two databases from the CHS registries from Israel (n=50,000, n=69,594). Participants with a high load of past infections (cohort 1, n=50,000) will be identified and matched in a 1:1 ratio to controls by age and sex. Probability of MI onset across a broad range of psychiatric disorders, including depression, bipolar disorder, anxiety and psychotic disorders will be explored. The probability of psychiatric relapse among individuals with pre-existing mental disorder following infection will be investigated in a cohort of 34,797 individuals with schizophrenia matched randomly to age and sex controls with no diagnosis of schizophrenia (n = 34,797) (cohort 2, total n=69,594, 5). Socio and sociodemographic factors which might serve as vulnerability or resilience factors will be assessed across both cohorts, and will include environmental factors such as socioeconomic status, familial status, healthcare utilization information and demographic factors. In addition, The CHS databases (n=50,000, n=69,594) will be utilized to study outcomes of infections in SMI. From the CHS databases in Israel, outcome of infections will be assessed in the two previously described cohorts. Severe outcomes will be defined as hospital admission \~two weeks after a diagnosis of an infection, among individuals with pre-existing anxiety, depression, bipolar diagnosis (n=50,000), and among patients with schizophrenia (n=69,594), as well as all-cause mortality. The following infections will be considered: Epstein Barr Virus, Cytomegalovirus, Toxoplasma Gondii, COVID-19, and Herpes viruses. Environmental protective and risk factors and their moderating role in the association between infection and outcome will include marital status, number of siblings, and sociodemographic factors. Vulnerability factors such as smoking, obesity, and comorbid physical illness will also be examined. The presence of pre-existing viral infections will be assessed as a potential vulnerability factor.

Conditions

Depression - Major Depressive Disorder; Anxiety; Bipolar; Schizophenia Disorder

Keywords

infections, mental disorders, cumulative effects, immunity, risk and resilience factors

Outcome Measures

Primary Outcomes (2)

• CHS 1: Mental Illness

  The development of mental illness, including anxiety, depression, bipolar and schizophrenia

  Up to 30 years.

• CHS 2: Post-infection relapse

  Post infection admissions, ER visits.

  3 months post infection

Study Arms (2)

CHS 1

Participants exposed to infections and unexposed to infections.

CHS 2

Schizophrenia and controls.

Eligibility Criteria

• Age: 0 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The Israel cohort consists of two databases from the Clalit Health Services (CHS) registries from Israel. The CHS is the largest of four operating healthcare organisations to provide healthcare to all citizens of Israel, and covers more than 50% of Israel's population. The CHS databases undergo periodic updating processes and have been validated by the registry algorithm as well as by many scientific organisations utilising the database. The diagnoses of chronic diseases are based on real-time input from healthcare providers, pharmacies, medical care facilities, and administrative computerised operating systems.

You may not qualify if:

• CHS 2:

Sponsors & Collaborators

• Shalvata Mental Health Center: lead
• University Hospital, Antwerp: collaborator
• San Raffaele University Hospital, Italy: collaborator
• Oslo University Hospital: collaborator

Study Sites (1)

University of Haifa

Haifa, Israel

Location

MeSH Terms

Conditions

Anxiety Disorders; Infections; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2026
• First Posted: March 6, 2026
• Study Start: August 17, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)