NCT02878408Recruiting
Immuno-Genetic, Inflammation, Retro-Virus, Environment
Immuno-Génétique, Inflammation, Retro-Virus, Environnement
Source: ClinicalTrials.gov · Last updated 22 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1100 (estimated)
- First submitted
- 22 Aug 2016
- Start date
- 7 Nov 2014
- Primary completion date
- Nov 2028
- Lead sponsor
- Pr. Marion Leboyer
- Diseases
- Schizophrenia, Bipolar disorder
- NCT number
- NCT02878408
What you commit to
- Study type: Interventional
- Planned participants: 1100
- From 7 Nov 2014 to the primary completion date, Nov 2028
- 6 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Severe neurologic illness
- 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
Other
- pregnant women
- Vaccination within 4 precedent weeks
- Immunosuppressing or immuno-modulating treatment.
Who the study is looking for
- Bipolar disorder or Schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders IV)
Age in the registry: 16 years to - · Sex: All · Accepts healthy volunteers
Sites (6)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Psychiatry Department of Perrens Hospital Coordinator of this site? Confirm its status | Bordeaux | France | Not yet recruiting |
| Clinical Investigations Center of Mondor Hospital Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Psychiatry Department of Mondor Hospital Coordinator of this site? Confirm its status | Créteil | France | Recruiting |
| Psychiatry Department of Widal Hospital Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| EPS Maison Blanche Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Psychiatry Department of R. Dubos Hospital Coordinator of this site? Confirm its status | Pontoise | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.