Status:
ACTIVE_NOT_RECRUITING
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
Lead Sponsor:
Sara Poletti
Conditions:
Severe Mental Illness
Inflammation
Eligibility:
All Genders
18-65 years
Brief Summary
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...
Eligibility Criteria
Inclusion
- 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),
Exclusion
Key Trial Info
Start Date :
May 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 2027
Estimated Enrollment :
408551 Patients enrolled
Trial Details
Trial ID
NCT06945627
Start Date
May 2 2024
End Date
March 1 2027
Last Update
May 14 2025
Active Locations (4)
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1
University of Antwerp
Antwerp, Belgium, Belgium, 2570
2
University of Haifa
Haifa, Israel, Israel, 3498838
3
IRCCS Ospedale San Raffaele
Milan, Italy, Italy, 20132
4
University of Oslo
Oslo, Norway, Norway, 0424