Bipolar DisorderI-GiveNCT02878408
Immuno-Genetic, Inflammation, Retro-Virus, Environment
A study testing Blood sampling in people with Bipolar Disorder and Schizophrenia, run by Pr. Marion Leboyer at 6 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Schizophrenia
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,100 participants
- Where
- 6 sitesFrance
- Study dates
- 7 Nov 2014to Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Bipolar disorder or Schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders IV)
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Jean-Romain Richard contact
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
Psychiatry Department of Perrens Hospital
Bordeaux
- Recruiting
Psychiatry Department of Mondor Hospital
Créteil, France, 94000
- Recruiting
Clinical Investigations Center of Mondor Hospital
Créteil, 94000
- Recruiting
Psychiatry Department of Widal Hospital
Paris, 75010
- Recruiting
EPS Maison Blanche
Paris, 75020
- Recruiting
Psychiatry Department of R. Dubos Hospital
Pontoise
About this study
Official title: 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.
Read the 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:
- 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,
- measuring the systemic associated immuno-inflammatory cascade in BD patients at different stages of the disorder and occurrence of medical comorbidities,
- identifying the clinical characteristics of patients according to HERV-W expression and immuno-inflammatory profiles,
- 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.
- Conditions
- Bipolar Disorder, Schizophrenia
- Being tested
- Blood sampling
- Medical subject headings
- Bipolar Disorder, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingGenetic
supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
| Study group | Role | What they receive |
|---|---|---|
| acute Bipolar disorder | Other | blood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection) Receives: Genetic: Blood sampling |
| acute Schizophrenia | Other | blood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection) Receives: Genetic: Blood sampling |
| stable Bipolar disorder | Other | blood sampling and data collection (only one visit) Receives: Genetic: Blood sampling |
| stable Schizophrenia | Other | blood sampling and data collection (only one visit) Receives: Genetic: Blood sampling |
| healthy control | Other | blood sampling and data collection (only one visit) Receives: Genetic: Blood sampling |
| TOC | Other | blood sampling and data collection (only one visit) Receives: Genetic: Blood sampling |
| Major Depressive Desorder | Other | blood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection) Receives: Genetic: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
HERV-W
measure of HERV retroviral DNA, RNA and envelop proteins
Measured: inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study start7 Nov 2014
- Primary completionNov 2028 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pr. Marion Leboyer
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Agency, France, Assistance Publique - Hôpitaux de Paris
- Responsible party
- Sponsor-investigator, Pr. Marion Leboyer, Fondation FondaMental
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878408
- Sponsor's protocol ID
- I-Give
- Other IDs
- IDRCB : 2013-A01639-36
- Acronym
- I-Give
- Status last verified
- May 2026
- First submitted
- 22 Aug 2016
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immuno-Génétique, Inflammation, Retro-Virus, Environnement
- ClinicalTrials.gov ID
- NCT02878408
- Acronym / sponsor ID
- I-Give / I-Give
- Conditions
- Bipolar Disorder, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Pr. Marion LeboyerUniversity, hospital or other
- Collaborators
- National Research Agency, France, Assistance Publique - Hôpitaux de Paris
- Study start
- 7 Nov 2014 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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,
- measuring the systemic associated immuno-inflammatory cascade in BD patients at different stages of the disorder and occurrence of medical comorbidities,
- identifying the clinical characteristics of patients according to HERV-W expression and immuno-inflammatory profiles,
- 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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| acute Bipolar disorder | Other | Genetic: Blood samplingblood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection) |
| acute Schizophrenia | Other | Genetic: Blood samplingblood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection) |
| stable Bipolar disorder | Other | Genetic: Blood samplingblood sampling and data collection (only one visit) |
| stable Schizophrenia | Other | Genetic: Blood samplingblood sampling and data collection (only one visit) |
| healthy control | Other | Genetic: Blood samplingblood sampling and data collection (only one visit) |
| TOC | Other | Genetic: Blood samplingblood sampling and data collection (only one visit) |
| Major Depressive Desorder | Other | Genetic: Blood samplingblood sampling and data collection Following visit at end of hospitalisation (blood sampling and data collection) |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Bipolar disorder or Schizophrenia (according to Diagnostic and Statistical Manual of Mental Disorders IV)
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplingsupplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors | Genetic | Major Depressive Desorder, TOC, acute Bipolar disorder, acute Schizophrenia, healthy control, stable Bipolar disorder, stable Schizophrenia |
Primary outcome
HERV-W
Time frame: inclusion
measure of HERV retroviral DNA, RNA and envelop proteins
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean-Romain Richard contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Bipolar Disorder and Schizophrenia, run by Pr. Marion Leboyer at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marion Leboyer, Pr ((33) 1 49 81 38 22, marion.leboyer@fondation-fondamental.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HERV-W (time frame: inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.