NCT07453420Fut, nem toboroz
Profiling Vulnerability and Resilience for Mental Illness Following Viral Infections: Translating Epidemiology to Deep-phenotyping.
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. júl. 23.
Rövid összefoglaló (regiszter, angolul)
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 second 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.
- Állapot (regiszter)
- Fut, nem toboroz
- Vizsgálattípus
- Megfigyeléses
- Résztvevők száma
- 100000 (tervezett)
- Első benyújtás
- 2026. márc. 1.
- Kezdés
- 2024. aug. 17.
- Elsődleges befejezés
- 2027. márc. 1.
- Fő szponzor
- Shalvata Mental Health Center
- Betegségek
- Depresszió
- NCT-szám
- NCT07453420
Mit vállalsz
- Vizsgálat típusa: Megfigyeléses
- Tervezett résztvevők: 100000
- 2024. aug. 17. és az elsődleges befejezés (2027. márc. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
Ki nem vehet részt
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Egyéb
- Termination of insurance and lack of successive medical follow up.
- In CHS 2:
- Lack of active diagnosis and place of residency outside of CHS catchment area.
Kiket keres a vizsgálat
- Individuals insured by the CHS since birth and with at least 10 years of follow up.
- Active diagnosis of schizophrenia in CHS registries during stages of analyses
- Place of residence is at the CHS hospital catchment areas (to ensure psychiatric hospitalisation is fully registered).
A regiszterben nem jelölt feltételek
- In CHS 1:
Életkor a regiszterben: 0 év – 30 év · Nem: nők és férfiak · Egészséges önkénteseket is fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of Haifa | Haifa | Izrael | Ismeretlen állapot |
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