Immuno-Genetic, Inflammation, Retro-Virus, Environment (I-Give)

May 19, 2026 updated by: Pr. Marion Leboyer

Immuno-Génétique, Inflammation, Retro-Virus, Environnement

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators and others have been able to demonstrate that HERV-W envelope gene (Env) encodes a pro-inflammatory and neurotoxic protein after reactivation by environmental factors. In this context, the investigators have reported preliminary data showing an association between Human Endogenous Retroviruses type "W" family (HERV-W) and major psychotic disorder, bipolar disorder (BD) and schizophrenia (SZ) : In 2008, the investigators reported for the first time, the presence of ENV protein in the serum of 50 % of SZ patients associated with a chronic inflammatory status reflected by elevated serum level of C-Reactive Protein (CRP). The investigators have been able to confirm this finding and extend it to BD and showed an elevation of HERV-W RNA transcripts both in BD and SZ as compared to healthy controls. Furthermore, the investigators also observed for the first time that toxoplasma Gondii, known to be able to induce reactivation of HERV-W, is associated with an increased risk to develop BD (OR: 2.3) close to the one previously observed in SZ (OR= 2.17)

The present project I-GIVE aims to extend and refine such findings and to obtain a proof of concept of the involvement of Human Endogenous Retrovirus elements in bipolar disorder and schizophrenia. I-GIVE is divided into four complementary scientific tasks:

  1. assessing the systemic HERV-W (ENV and GAG) antigen serum levels and the RNA and DNA copy number variants of stabilized and acutely ill patients,
  2. measuring the systemic associated immuno-inflammatory cascade in BD patients at different stages of the disorder and occurrence of medical comorbidities,
  3. identifying the clinical characteristics of patients according to HERV-W expression and immuno-inflammatory profiles,
  4. exploring the gene (immuno-genetic) x environment interactions that may modulate the immuno-inflammatory response

Clinical and biological data from acute BP and SZ patients will be compared first with themselves at two different times. They will be compared also to healthy control's data, and third to stabilised BP and SZ patients.

Study Type

Interventional

Enrollment (Estimated)

1100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France
        • Not yet recruiting
        • Psychiatry Department of Perrens Hospital
      • Créteil, France, 94000
        • Recruiting
        • Clinical Investigations Center of Mondor Hospital
      • Paris, France, 75010
        • Recruiting
        • Psychiatry Department of Widal Hospital
      • Paris, France, 75020
        • Recruiting
        • EPS Maison Blanche
      • Pontoise, France
        • Recruiting
        • Psychiatry Department of R. Dubos Hospital
    • France
      • Créteil, France, France, 94000
        • Recruiting
        • Psychiatry Department of Mondor Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: acute Bipolar disorder
blood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection)
Genetic: Blood sampling
supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
Other: acute Schizophrenia
blood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection)
Genetic: Blood sampling
supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
Other: stable Bipolar disorder
blood sampling and data collection (only one visit)
Genetic: Blood sampling
supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
Other: stable Schizophrenia
blood sampling and data collection (only one visit)
Genetic: Blood sampling
supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
Other: healthy control
blood sampling and data collection (only one visit)
Genetic: Blood sampling
supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
Other: TOC
blood sampling and data collection (only one visit)
Genetic: Blood sampling
supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
Other: Major Depressive Desorder
blood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection)
Genetic: Blood sampling
supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HERV-W
Time Frame: inclusion
measure of HERV retroviral DNA, RNA and envelop proteins
inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pr. Marion Leboyer

Collaborators

Assistance Publique - Hôpitaux de Paris
National Research Agency, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 7, 2014

Primary Completion (Estimated)

November 1, 2028

Study Completion (Estimated)

November 1, 2028

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimated)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • I-Give
  • IDRCB : 2013-A01639-36 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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