Exploring the role of immune and genetic factors in bipolar disorder and schizophrenia
Official title: Immuno-Génétique, Inflammation, Retro-Virus, Environnement
Run by Fondation FondaMental · NCT02878408 · Data updated 2026-11-12
This study is trying to see if certain immune and genetic factors related to a type of virus can help us understand and improve treatments for people with bipolar disorder and schizophrenia.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 16 Years and up |
| Sex | All |
| Enrollment | 1100 (estimated) |
| Sponsor | Fondation FondaMental Academic / other |
| Locations | 6 sites (Créteil, France and 5 other locations) |
| Status | Recruiting |
| Started | November 7, 2014 |
| Main results expected | November 2028 |
| Study ends | November 2028 |
| Registry record updated | May 22, 2026 |
| Trial ID | NCT02878408 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are individuals diagnosed with bipolar disorder or schizophrenia.
✕Probably not a fit
Patients who are pregnant, have severe neurological illnesses, or are undergoing immunosuppressive treatments may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the connection between Human Endogenous Retroviruses (HERV-W) and the development of bipolar disorder and schizophrenia by examining immune responses and environmental influences. It aims to identify new biomarkers that correlate with clinical profiles and immunological markers, potentially leading to innovative treatment approaches. The research involves blood sampling to assess levels of specific viral proteins and genetic variants in patients with these psychiatric disorders. By combining clinical, viral, immunological, and genetic methodologies, the study seeks to enhance our understanding of the pathophysiological mechanisms underlying these conditions.
Why it matters
Potential benefit: If successful, this study could lead to the development of personalized treatments for bipolar disorder and schizophrenia based on identified biomarkers.
How similar studies have gone: Other studies have shown promising results in linking immune factors to psychiatric disorders, but this specific approach focusing on HERV-W is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Psychiatry Department of Mondor Hospital
Créteil, France, France Recruiting -
Clinical Investigations Center of Mondor Hospital
Créteil, France Recruiting -
Psychiatry Department of Widal Hospital
Paris, France Recruiting -
EPS Maison Blanche
Paris, France Recruiting -
Psychiatry Department of R. Dubos Hospital
Pontoise, France Recruiting -
Psychiatry Department of Perrens Hospital
Bordeaux, France Not yet recruiting
Study contacts
- Study coordinator: Marion Leboyer, Pr
- Email: marion.leboyer@fondation-fondamental.org
- Phone: (33) 1 49 81 38 22
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.