Immuno-Genetic, Inflammation, Retro-Virus, Environment
Recruiting now · Not applicable
Conditions studied: Bipolar Disorder, Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT02878408
- Run by
- Pr. Marion Leboyer
- People needed
- 1100
- Starts
- 2014-11-07
- Expected to finish
- 2028-11-01
- Last updated by the study team
- 2026-05-22
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Bipolar disorder or Schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders IV)
You may not qualify if…
- 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
Where it is running
- Psychiatry Department of Mondor Hospital — Créteil, France, France (enrolling)
- Clinical Investigations Center of Mondor Hospital — Créteil, France (enrolling)
- Psychiatry Department of Widal Hospital — Paris, France (enrolling)
- EPS Maison Blanche — Paris, France (enrolling)
- Psychiatry Department of R. Dubos Hospital — Pontoise, France (enrolling)
- Psychiatry Department of Perrens Hospital — Bordeaux, France
Full record on ClinicalTrials.gov
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