Exploring the role of immune and genetic factors in bipolar disorder and schizophrenia
Immuno-Génétique, Inflammation, Retro-Virus, Environnement
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1100 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Fondation FondaMental Academic / other |
| Locations | 6 sites (Bordeaux and 5 other locations) |
| Trial ID | NCT02878408 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with bipolar disorder or schizophrenia.
Not a fit: Patients who are pregnant, have severe neurological illnesses, or are undergoing immunosuppressive treatments may not benefit from this study.
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 performed: Other studies have shown promising results in linking immune factors to psychiatric disorders, but this specific approach focusing on HERV-W is relatively novel.
Eligibility criteria
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 this trial is running
Bordeaux and 5 other locations
- Psychiatry Department of Perrens Hospital — Bordeaux, France (Not_yet_recruiting)
- Clinical Investigations Center of Mondor Hospital — Créteil, France (Recruiting)
- Psychiatry Department 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)
Study contacts
- Study coordinator: Marion Leboyer, Pr
- Email: marion.leboyer@fondation-fondamental.org
- Phone: (33) 1 49 81 38 22
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.