Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
NCT ID: NCT06945627
Last Updated: 2025-05-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Total Enrollment
408551 participants
Study Classification
OBSERVATIONAL
Study Start Date
2024-05-02
Study Completion Date
2027-03-31
Brief Summary
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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.
* 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.
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Detailed Description
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Conditions
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Severe Mental Illness
Inflammation
Viral Infections
Mood Disorders
Schizophrenia
Study Design
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Observational Model Type
COHORT
Study Time Perspective
RETROSPECTIVE
Study Groups
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Trans-D
This research doesn't involve any kind of intervention on the study participants
Intervention Type
OTHER
This research doesn't involve any kind of intervention on the study participants
Cov-N-Psy
This research doesn't involve any kind of intervention on the study participants
Intervention Type
OTHER
This research doesn't involve any kind of intervention on the study participants
CHS1
This research doesn't involve any kind of intervention on the study participants
Intervention Type
OTHER
This research doesn't involve any kind of intervention on the study participants
CHS2
This research doesn't involve any kind of intervention on the study participants
Intervention Type
OTHER
This research doesn't involve any kind of intervention on the study participants
MOOD-MI
This research doesn't involve any kind of intervention on the study participants
Intervention Type
OTHER
This research doesn't involve any kind of intervention on the study participants
COVID-MI
This research doesn't involve any kind of intervention on the study participants
Intervention Type
OTHER
This research doesn't involve any kind of intervention on the study participants
MoBa
This research doesn't involve any kind of intervention on the study participants
Intervention Type
OTHER
This research doesn't involve any kind of intervention on the study participants
TOP
This research doesn't involve any kind of intervention on the study participants
Intervention Type
OTHER
This research doesn't involve any kind of intervention on the study participants
Interventions
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This research doesn't involve any kind of intervention on the study participants
This research doesn't involve any kind of intervention on the study participants
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
Exclusion Criteria
* 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
* 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.
* 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),
* 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
* 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.
* 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),
Minimum Eligible Age
18 Years
Maximum Eligible Age
65 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Sara Poletti
OTHER
Sponsor Role
lead
Responsible Party
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Sara Poletti
Principal Investigator
Responsibility Role
SPONSOR_INVESTIGATOR
Principal Investigators
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Sara Poletti, PhD
Role: PRINCIPAL_INVESTIGATOR
IRCCS Ospedale San Raffaele
Locations
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University of Antwerp
Antwerp, Belgium, Belgium
Site Status
University of Haifa
Haifa, Israel, Israel
Site Status
IRCCS Ospedale San Raffaele
Milan, Italy, Italy
Site Status
University of Oslo
Oslo, Norway, Norway
Site Status
Countries
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Belgium
Israel
Italy
Norway
References
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Lalousis PA, Schmaal L, Wood SJ, Reniers RLEP, Barnes NM, Chisholm K, Griffiths SL, Stainton A, Wen J, Hwang G, Davatzikos C, Wenzel J, Kambeitz-Ilankovic L, Andreou C, Bonivento C, Dannlowski U, Ferro A, Lichtenstein T, Riecher-Rossler A, Romer G, Rosen M, Bertolino A, Borgwardt S, Brambilla P, Kambeitz J, Lencer R, Pantelis C, Ruhrmann S, Salokangas RKR, Schultze-Lutter F, Schmidt A, Meisenzahl E, Koutsouleris N, Dwyer D, Upthegrove R; PRONIA Consortium. Neurobiologically Based Stratification of Recent-Onset Depression and Psychosis: Identification of Two Distinct Transdiagnostic Phenotypes. Biol Psychiatry. 2022 Oct 1;92(7):552-562. doi: 10.1016/j.biopsych.2022.03.021. Epub 2022 Apr 12.
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Goldsmith DR, Rapaport MH, Miller BJ. A meta-analysis of blood cytokine network alterations in psychiatric patients: comparisons between schizophrenia, bipolar disorder and depression. Mol Psychiatry. 2016 Dec;21(12):1696-1709. doi: 10.1038/mp.2016.3. Epub 2016 Feb 23.
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Zhang Y, Wang J, Ye Y, Zou Y, Chen W, Wang Z, Zou Z. Peripheral cytokine levels across psychiatric disorders: A systematic review and network meta-analysis. Prog Neuropsychopharmacol Biol Psychiatry. 2023 Jul 13;125:110740. doi: 10.1016/j.pnpbp.2023.110740. Epub 2023 Mar 8.
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Tylee DS, Sun J, Hess JL, Tahir MA, Sharma E, Malik R, Worrall BB, Levine AJ, Martinson JJ, Nejentsev S, Speed D, Fischer A, Mick E, Walker BR, Crawford A, Grant SFA, Polychronakos C, Bradfield JP, Sleiman PMA, Hakonarson H, Ellinghaus E, Elder JT, Tsoi LC, Trembath RC, Barker JN, Franke A, Dehghan A; 23 and Me Research Team; Inflammation Working Group of the CHARGE Consortium; METASTROKE Consortium of the International Stroke Genetics Consortium; Netherlands Twin Registry; neuroCHARGE Working Group; Obsessive Compulsive and Tourette Syndrome Working Group of the Psychiatric Genomics Consortium; Faraone SV, Glatt SJ. Genetic correlations among psychiatric and immune-related phenotypes based on genome-wide association data. Am J Med Genet B Neuropsychiatr Genet. 2018 Oct;177(7):641-657. doi: 10.1002/ajmg.b.32652. Epub 2018 Oct 16.
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Shorter JR, Meijsen J, Nudel R, Krebs M, Gadin J, Mikkelsen DH, Nogueira Avelar E Silva R, Benros ME, Thompson WK, Ingason A, Werge T. Infection Polygenic Factors Account for a Small Proportion of the Relationship Between Infections and Mental Disorders. Biol Psychiatry. 2022 Aug 15;92(4):283-290. doi: 10.1016/j.biopsych.2022.01.007. Epub 2022 Jan 24.
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BACKGROUND
Debost JPG, Thorsteinsson E, Trabjerg B, Benros ME, Albinana C, Vilhjalmsson BJ, Borglum A, Mors O, Werge T, Mortensen PB, Agerbo E, Petersen LV. Genetic and psychosocial influence on the association between early childhood infections and later psychiatric disorders. Acta Psychiatr Scand. 2022 Nov;146(5):406-419. doi: 10.1111/acps.13491. Epub 2022 Sep 8.
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BACKGROUND
Benros ME, Waltoft BL, Nordentoft M, Ostergaard SD, Eaton WW, Krogh J, Mortensen PB. Autoimmune diseases and severe infections as risk factors for mood disorders: a nationwide study. JAMA Psychiatry. 2013 Aug;70(8):812-20. doi: 10.1001/jamapsychiatry.2013.1111.
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BACKGROUND
Vai B, Parenti L, Bollettini I, Cara C, Verga C, Melloni E, Mazza E, Poletti S, Colombo C, Benedetti F. Predicting differential diagnosis between bipolar and unipolar depression with multiple kernel learning on multimodal structural neuroimaging. Eur Neuropsychopharmacol. 2020 May;34:28-38. doi: 10.1016/j.euroneuro.2020.03.008. Epub 2020 Mar 29.
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BACKGROUND
Benros ME, Nielsen PR, Nordentoft M, Eaton WW, Dalton SO, Mortensen PB. Autoimmune diseases and severe infections as risk factors for schizophrenia: a 30-year population-based register study. Am J Psychiatry. 2011 Dec;168(12):1303-10. doi: 10.1176/appi.ajp.2011.11030516.
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BACKGROUND
McGrath JJ, Pemberton MR, Welham JL, Murray RM. Schizophrenia and the influenza epidemics of 1954, 1957 and 1959: a southern hemisphere study. Schizophr Res. 1994 Dec;14(1):1-8. doi: 10.1016/0920-9964(94)90002-7.
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Mazza MG, Palladini M, Villa G, Agnoletto E, Harrington Y, Vai B, Benedetti F. Prevalence of depression in SARS-CoV-2 infected patients: An umbrella review of meta-analyses. Gen Hosp Psychiatry. 2023 Jan-Feb;80:17-25. doi: 10.1016/j.genhosppsych.2022.12.002. Epub 2022 Dec 7.
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BACKGROUND
Mazza MG, De Lorenzo R, Conte C, Poletti S, Vai B, Bollettini I, Melloni EMT, Furlan R, Ciceri F, Rovere-Querini P; COVID-19 BioB Outpatient Clinic Study group; Benedetti F. Anxiety and depression in COVID-19 survivors: Role of inflammatory and clinical predictors. Brain Behav Immun. 2020 Oct;89:594-600. doi: 10.1016/j.bbi.2020.07.037. Epub 2020 Jul 30.
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BACKGROUND
Vai B, Mazza MG, Delli Colli C, Foiselle M, Allen B, Benedetti F, Borsini A, Casanova Dias M, Tamouza R, Leboyer M, Benros ME, Branchi I, Fusar-Poli P, De Picker LJ. Mental disorders and risk of COVID-19-related mortality, hospitalisation, and intensive care unit admission: a systematic review and meta-analysis. Lancet Psychiatry. 2021 Sep;8(9):797-812. doi: 10.1016/S2215-0366(21)00232-7. Epub 2021 Jul 17.
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Vai B, Mazza MG, Marisa CD, Beezhold J, Karkkainen H, Saunders J, Samochowiec J, Benedetti F, Leboyer M, Fusar-Poli P, De Picker L. Joint European policy on the COVID-19 risks for people with mental disorders: An umbrella review and evidence- and consensus-based recommendations for mental and public health. Eur Psychiatry. 2022 Aug 16;65(1):e47. doi: 10.1192/j.eurpsy.2022.2307.
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Mazza MG, Palladini M, De Lorenzo R, Bravi B, Poletti S, Furlan R, Ciceri F; COVID-19 BioB Outpatient Clinic Study group; Rovere-Querini P, Benedetti F. One-year mental health outcomes in a cohort of COVID-19 survivors. J Psychiatr Res. 2022 Jan;145:118-124. doi: 10.1016/j.jpsychires.2021.11.031. Epub 2021 Nov 22.
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Poletti S, Vai B, Mazza MG, Zanardi R, Lorenzi C, Calesella F, Cazzetta S, Branchi I, Colombo C, Furlan R, Benedetti F. A peripheral inflammatory signature discriminates bipolar from unipolar depression: A machine learning approach. Prog Neuropsychopharmacol Biol Psychiatry. 2021 Mar 8;105:110136. doi: 10.1016/j.pnpbp.2020.110136. Epub 2020 Oct 9.
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Poletti S, de Wit H, Mazza E, Wijkhuijs AJM, Locatelli C, Aggio V, Colombo C, Benedetti F, Drexhage HA. Th17 cells correlate positively to the structural and functional integrity of the brain in bipolar depression and healthy controls. Brain Behav Immun. 2017 Mar;61:317-325. doi: 10.1016/j.bbi.2016.12.020. Epub 2016 Dec 23.
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Poletti S, Leone G, Hoogenboezem TA, Ghiglino D, Vai B, de Wit H, Wijkhuijs AJM, Locatelli C, Colombo C, Drexhage HA, Benedetti F. Markers of neuroinflammation influence measures of cortical thickness in bipolar depression. Psychiatry Res Neuroimaging. 2019 Mar 30;285:64-66. doi: 10.1016/j.pscychresns.2019.01.009. Epub 2019 Jan 29.
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Benedetti F, Palladini M, Paolini M, Melloni E, Vai B, De Lorenzo R, Furlan R, Rovere-Querini P, Falini A, Mazza MG. Brain correlates of depression, post-traumatic distress, and inflammatory biomarkers in COVID-19 survivors: A multimodal magnetic resonance imaging study. Brain Behav Immun Health. 2021 Dec;18:100387. doi: 10.1016/j.bbih.2021.100387. Epub 2021 Nov 2.
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Reference Type
BACKGROUND
Other Identifiers
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ERP-2023-23684210
Identifier Type: -
Identifier Source: org_study_id
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