Immuno-Genetic, Inflammation, Retro-Virus, Environment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorPr. Marion Leboyer

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Blood sampling

    Genetic

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

Treatment groups

1,100 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: acute Bipolar disorderOther 1 intervention
Group B: acute SchizophreniaOther 1 intervention
Group C: stable Bipolar disorderOther 1 intervention
Group D: stable SchizophreniaOther 1 intervention
Group E: healthy controlOther 1 intervention
Group F: TOCOther 1 intervention
Group G: Major Depressive DesorderOther 1 intervention

Trial outcomes

Primary outcomes

1

HERV-W

measure of HERV retroviral DNA, RNA and envelop proteins

Time frame
inclusion

Secondary outcomes

Other outcomes

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