Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT02878408 En recrutement IDF

Titre

Immuno-Génétique, Inflammation, Retro-Virus, Environnement (I-Give)

Type

Interventional

Pathologie

Trouble bipolaire
Inflammation
Schizophrénie

Phase

N/A

Promoteur

Pr. Marion Leboyer (Voir sur ClinicalTrials)

Date de début

novembre 2014

Date de fin

novembre 2025

Dernière mise à jour

29 juin 2024

Résumé

Immunology combined to neurobiology now offer prominent tools to yield biomarkers, so far missing in psychiatry, and to design innovative treatment approaches based on the discovery of new molecular and cellular targets. As Bipolar Disorder and Schizophrenia are now known to be significantly associated with neuro-inflammation, the project I-GIVE will combine multidisciplinary approaches (clinical, viral, immunological, genetic) to explore a global hypothesis placing the Human Endogenous Retro-Virus, HERV-W, at the crossroads between susceptibility to environmental factors (such as winter-spring births, infections, urbanicity...) and genetic factors controlling immune responses. Thus I-GIVE will allow identification of new biomarkers and their correlation with clinical profiles and immuno-inflammatory/immuno-genetic markers, and description of patho-physiological mechanisms of a psychiatric disorder. In addition, I-GIVE should help to design innovative treatments and foster personalized psychiatry tailored to the needs of each patient. Notably, monoclonal antibodies anti-HERV-W Env will be assessed in a preclinical model for their ability to slow, stop, or even reverse the progression of the psychosis in patients. I-GIVE project should thus lead to major results that will have strong impacts on the scientific community, pharmaceutical industries and, in a longer term, on improvement of patients suffering Bipolar Disorder or Schizophrenia and their family.

Détail

Voir le détail The investigators and others have been able to demonstrate that HERV-W envelope gene (Env) encodes a pro-inflammatory and neurotoxic protein after reactivation by environmental factors. In this context, the investigators have reported preliminary data showing an association between Human Endogenous Retroviruses type "W" family (HERV-W) and major psychotic disorder, bipolar disorder (BD) and schizophrenia (SZ) : In 2008, the investigators reported for the first time, the presence of ENV protein in the serum of 50 % of SZ patients associated with a chronic inflammatory status reflected by elevated serum level of C-Reactive Protein (CRP). The investigators have been able to confirm this finding and extend it to BD and showed an elevation of HERV-W RNA transcripts both in BD and SZ as compared to healthy controls. Furthermore, the investigators also observed for the first time that toxoplasma Gondii, known to be able to induce reactivation of HERV-W, is associated with an increased risk to develop BD (OR: 2.3) close to the one previously observed in SZ (OR= 2.17) The present project I-GIVE aims to extend and refine such findings and to obtain a proof of concept of the involvement of Human Endogenous Retrovirus elements in bipolar disorder and schizophrenia. I-GIVE is divided into four complementary scientific tasks: 1. assessing the systemic HERV-W (ENV and GAG) antigen serum levels and the RNA and DNA copy number variants of stabilized and acutely ill patients, 2. measuring the systemic associated immuno-inflammatory cascade in BD patients at different stages of the disorder and occurrence of medical comorbidities, 3. identifying the clinical characteristics of patients according to HERV-W expression and immuno-inflammatory profiles, 4. exploring the gene (immuno-genetic) x environment interactions that may modulate the immuno-inflammatory response Clinical and biological data from acute BP and SZ patients will be compared first with themselves at two different times. They will be compared also to healthy control's data, and third to stabilised BP and SZ patients. Fermer le détail

Etablissements

Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
HOPITAL NOVO	En recrutement IDF	Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
EPS Maison Blanche - 75020 - Paris - France	En recrutement	Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
Clinical Investigations Center of Mondor Hospital - 94000 - Créteil - France	En recrutement	Contact (sur clinicalTrials)
Psychiatry Department of Mondor Hospital - 94000 - Créteil - France	En recrutement	Contact (sur clinicalTrials)
Psychiatry Department of Perrens Hospital - Bordeaux - France	Recrutement non commencé	Contact (sur clinicalTrials)
Psychiatry Department of Widal Hospital - 75010 - Paris - France	En recrutement	Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

Inclusion Criteria:

- Bipolar disorder or Schizophrenia (according to Diagnostic and Statistical Manual of
Mental Disorders IV)

Critère de non inclusion

- pregnant women

- Vaccination within 4 precedent weeks

- Severe neurologic illness

- Immunosuppressing or immuno-modulating treatment.

- Infectious disease within 4 precedent weeks (including HIV 1 et 2, Hepatite B, C)

- Refuse to have HIV and hepatite B et C tests or to be informed of their results

NCT02878408 - Immuno-Génétique, Inflammation, Retro-Virus, Environnement (I-Give)

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