Severe Mental IllnessVIRAL-MINCT06945627
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections
An observational study of Severe Mental Illness and Inflammation, run by Sara Poletti at 4 sites in 4 countries.
Trial 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 contribution to severe infective outcomes in people with pre-existing mental illness. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Severe Mental Illness, Inflammation, Viral Infections
- What is being tested?
- This research doesn't involve any kind of intervention on the study participants
- How many people
- 408,551 participants
- Where
- 4 sitesin 4 countries
- Study dates
- 2 May 2024to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with major depressive disorder or bipolar disorder (MOOD-MI cohort) and patients with COVID-19 (COVID-MI cohort). For epidemiological cohorts (MoBa, TOP, CHS) any patients with severe mental illnesses
Who may be able to join
- 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
Who cannot join
- 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
Show all 25Show fewer
- 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.
- 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),
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections: Translating Epidemiology to Deep-phenotyping
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?
Read more
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.
- Being tested
- This research doesn't involve any kind of intervention on the study participants
- Medical subject headings
- Mental Disorders, Inflammation, Virus Diseases, Mood Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This research doesn't involve any kind of intervention on the study participantsOther
This research doesn't involve any kind of intervention on the study participants
| Study group | Role | What they receive |
|---|---|---|
| Trans-D | Not described Receives: Other: This research doesn't involve any kind of intervention on the study participants | |
| Cov-N-Psy | Not described Receives: Other: This research doesn't involve any kind of intervention on the study participants | |
| CHS1 | Not described Receives: Other: This research doesn't involve any kind of intervention on the study participants | |
| CHS2 | Not described Receives: Other: This research doesn't involve any kind of intervention on the study participants | |
| MOOD-MI | Not described Receives: Other: This research doesn't involve any kind of intervention on the study participants | |
| COVID-MI | Not described Receives: Other: This research doesn't involve any kind of intervention on the study participants | |
| MoBa | Not described Receives: Other: This research doesn't involve any kind of intervention on the study participants | |
| TOP | Not described Receives: Other: This research doesn't involve any kind of intervention on the study participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of hospital admission for mental illness after infection diagnosis
number of onset or relapse of mental illness following infection
Measured: 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)
Measured: 3 years
Secondary outcomes (4)
Environmental risk and resilience factors for mental illness and severe outcomes
socio-economic socio-demographic variables inflammatory markers levels, timing and type of infection,
Measured: 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
Measured: 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
Measured: 3 years
genes or proteins that might be modified using drugs
target genes involved in severe and post-infectious MI.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start2 May 2024
- Primary completion2 May 2026
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Severe Mental IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 408,551 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sara Poletti
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sara Poletti, IRCCS San Raffaele
- Investigators
- Sara Poletti, PhD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945627
- Sponsor's protocol ID
- ERP-2023-23684210
- Acronym
- VIRAL-MI
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2025
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35717212Goldsmith 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.
PubMed 26903267Zhang 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.
PubMed 36893912Tylee 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.
PubMed 30325587Shorter 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.
PubMed 35305821Debost 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.
PubMed 35999619Benros 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.
PubMed 23760347Vai 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.
PubMed 32238313Benros 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.
PubMed 22193673McGrath 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.
PubMed 7893616Mazza 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.
PubMed 36535239Mazza 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.
PubMed 32738287Vai 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.
PubMed 34274033Vai 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.
PubMed 35971656De Picker LJ, Victoriano GM, Richards R, Gorvett AJ, Lyons S, Buckland GR, Tofani T, Norman JL, Chatelet DS, Nicoll JAR, Boche D. Immune environment of the brain in schizophrenia and during the psychotic episode: A human post-mortem study. Brain Behav Immun. 2021 Oct;97:319-327. doi: 10.1016/j.bbi.2021.07.017. Epub 2021 Jul 30.
PubMed 34339805
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections: Translating Epidemiology to Deep-phenotyping
- ClinicalTrials.gov ID
- NCT06945627
- Acronym / sponsor ID
- VIRAL-MI / ERP-2023-23684210
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 408,551 participants (actual)
- Lead sponsor
- Sara PolettiUniversity, hospital or other
- Study start
- 2 May 2024 (actual)
- Primary completion
- 2 May 2026 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Trans-D | – | Other: This research doesn't involve any kind of intervention on the study participants |
| Cov-N-Psy | – | Other: This research doesn't involve any kind of intervention on the study participants |
| CHS1 | – | Other: This research doesn't involve any kind of intervention on the study participants |
| CHS2 | – | Other: This research doesn't involve any kind of intervention on the study participants |
| MOOD-MI | – | Other: This research doesn't involve any kind of intervention on the study participants |
| COVID-MI | – | Other: This research doesn't involve any kind of intervention on the study participants |
| MoBa | – | Other: This research doesn't involve any kind of intervention on the study participants |
| TOP | – | Other: This research doesn't involve any kind of intervention on the study participants |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with major depressive disorder or bipolar disorder (MOOD-MI cohort) and patients with COVID-19 (COVID-MI cohort). For epidemiological cohorts (MoBa, TOP, CHS) any patients with severe mental illnesses
Key inclusion criteria (7 listed)
- A depressive episode according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria in the course of MDD or BD with:
- 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
Key exclusion criteria (25 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This research doesn't involve any kind of intervention on the study participantsThis research doesn't involve any kind of intervention on the study participants | Other | CHS1, CHS2, COVID-MI, Cov-N-Psy, MOOD-MI, MoBa, TOP, Trans-D |
Primary outcome
number of hospital admission for mental illness after infection diagnosis
Time frame: 3 years
number of onset or relapse of mental illness following infection
number of infections (Pathogen Burden Summary - PBS) in patients with mental illness
Time frame: 3 years
number of samples positive for antibodies for viruses associated with Mental illness in the literature (IgG, expressed as AU/mL)
4 secondary outcomes
Environmental risk and resilience factors for mental illness and severe outcomes
Time frame: 3 years
Neurobiological risk and resilience factors for mental illnesses and severe outcomes
Time frame: 3 years
Predictive risk models based on an individual biological and environmental signatures
Time frame: 3 years
genes or proteins that might be modified using drugs
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
- Background: PubMed 35717212Lalousis 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.
- Background: PubMed 26903267Goldsmith 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.
- Background: PubMed 36893912Zhang 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.
- Background: PubMed 30325587Tylee 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.
- Background: PubMed 35305821Shorter 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.
- Background: PubMed 35999619Debost 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.
- Background: PubMed 23760347Benros 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.
- Background: PubMed 32238313Vai 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.
- Background: PubMed 22193673Benros 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.
- Background: PubMed 7893616McGrath 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.
- Background: PubMed 36535239Mazza 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.
- Background: PubMed 32738287Mazza 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Poletti, PhD principal investigator
IRCCS Ospedale San Raffaele
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Mental Illness and Inflammation, run by Sara Poletti at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Israel, Italy, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of hospital admission for mental illness after infection diagnosis (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06945627, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.