Immuno-Genetic, Inflammation, Retro-Virus, Environment
I-Give
Immuno-Génétique, Inflammation, Retro-Virus, Environnement
2 other identifiers
interventional
1,100
1 country
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2014
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2014
CompletedFirst Submitted
Initial submission to the registry
August 22, 2016
CompletedFirst Posted
Study publicly available on registry
August 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
May 22, 2026
May 1, 2026
14 years
August 22, 2016
May 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
HERV-W
measure of HERV retroviral DNA, RNA and envelop proteins
inclusion
Study Arms (7)
acute Bipolar disorder
OTHERblood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection)
acute Schizophrenia
OTHERblood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection)
stable Bipolar disorder
OTHERblood sampling and data collection (only one visit)
stable Schizophrenia
OTHERblood sampling and data collection (only one visit)
healthy control
OTHERblood sampling and data collection (only one visit)
TOC
OTHERblood sampling and data collection (only one visit)
Major Depressive Desorder
OTHERblood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection)
Interventions
supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pr. Marion Leboyerlead
- National Research Agency, Francecollaborator
- Assistance Publique - Hôpitaux de Pariscollaborator
Study Sites (6)
Psychiatry Department of Mondor Hospital
Créteil, France, 94000, France
Psychiatry Department of Perrens Hospital
Bordeaux, France
Clinical Investigations Center of Mondor Hospital
Créteil, 94000, France
Psychiatry Department of Widal Hospital
Paris, 75010, France
EPS Maison Blanche
Paris, 75020, France
Psychiatry Department of R. Dubos Hospital
Pontoise, France
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Responsible for Pôle de psychiatrie of Hospital Albert Chenevier- Henri Mondor
Study Record Dates
First Submitted
August 22, 2016
First Posted
August 25, 2016
Study Start
November 7, 2014
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
May 22, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will not share