NCT02878408 Immuno-Genetic, Inflammation, Retro-Virus, Environment
| NCT ID | NCT02878408 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Pr. Marion Leboyer |
| Condition | Bipolar Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,100 participants |
| Start Date | 2014-11-07 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,100 participants in total. It began in 2014-11-07 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT02878408 clinical trial?
This trial is open to participants of all sexes, aged 16 Years or older, studying Bipolar Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT02878408 currently recruiting?
Yes, NCT02878408 is actively recruiting participants. Contact the research team at marion.leboyer@fondation-fondamental.org for enrollment information.
Where is the NCT02878408 trial being conducted?
This trial is being conducted at Créteil, France, Bordeaux, France, Créteil, France, Paris, France and 2 additional locations.
Who is sponsoring the NCT02878408 clinical trial?
NCT02878408 is sponsored by Pr. Marion Leboyer. The trial plans to enroll 1,100 participants.
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