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Recruiting Not applicable

Immuno-Genetic, Inflammation, Retro-Virus, Environment

NCT02878408 · tracked via the Priya Life Science France tracker
Sponsor
Pr. Marion Leboyer
Phase
Not applicable
Started
2014-11-07
Last updated
2026-05-22

Condition(s) studied

Bipolar DisorderSchizophrenia

Investigational drug(s) / intervention(s)

Blood sampling

Blood sampling: supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors

Study summary

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

Sex
ALL
Min age
16 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Bipolar disorder or Schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders IV) Exclusion Criteria: * 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

Primary outcome measure(s)

  • HERV-W — inclusion
    measure of HERV retroviral DNA, RNA and envelop proteins

Trial sites (6)

FacilityCityRegionStatus
Psychiatry Department of Mondor Hospital Créteil France Recruiting
Psychiatry Department of Perrens Hospital Bordeaux France Not Yet Recruiting
Clinical Investigations Center of Mondor Hospital Créteil France Recruiting
Psychiatry Department of Widal Hospital Paris France Recruiting
EPS Maison Blanche Paris France Recruiting
Psychiatry Department of R. Dubos Hospital Pontoise France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02878408 on ClinicalTrials.gov ↗ ← All trials in France