About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Bipolar disorder or Schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders IV)
Disqualifiers
pregnant women
Vaccination within 4 precedent weeks
Severe neurologic illness
Immunosuppressing or immuno-modulating treatment.
Trial design
Parallel
Treatments tested in this trial
Blood sampling
Geneticsupplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
Treatment groups
7
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
HERV-W
measure of HERV retroviral DNA, RNA and envelop proteins
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Pr. Marion Leboyer
Lead sponsor
Fondation FondaMental
Sponsor institution
National Research Agency, France
Collaborator
Assistance Publique - Hôpitaux de Paris
Collaborator