Exploring medical comorbidities in bipolar disorder
Medical Comorbidities in Bipolar Disorder : Clinical Validation of Risk Factors and Biomarkers to Improve Prevention and Treatment;
This study is trying to see how common other health problems are in people with bipolar disorder and how these issues affect their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fondation FondaMental Academic / other |
| Locations | 1 site (Créteil) |
| Trial ID | NCT06872398 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the prevalence and impact of medical comorbidities in individuals with bipolar disorder (BD). It utilizes data from Nordic biobanks and medical registers to identify risk factors and the natural history of these comorbidities. Additionally, a clinical study will involve 400 participants across five European centers to assess their overall clinical profiles and quantify the effects of comorbid conditions. The study employs machine learning models to predict outcomes related to metabolic syndrome and other comorbidities.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a primary diagnosis of bipolar disorder who have engaged with mental health services in the past year.
Not a fit: Patients with severe psychiatric comorbidities, cognitive impairments, or those projected to move within the next year may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and treatment outcomes for patients with bipolar disorder by personalizing care based on identified comorbidities.
How similar studies have performed: Other studies have shown success in exploring comorbidities in psychiatric disorders, but this specific approach utilizing machine learning and extensive registry data is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary diagnosis of BP I, BP II, or BP NOS * Have had at least one contact with mental health services in the past year * Be aged between 18 and 65 years old * Have signed an informed consent Exclusion Criteria: * Projected move within the next year. * Severe psychiatric comorbidities (schizophrenia spectrum disorders). * Severe cognitive impairment. * Severe substance or alcohol abuse: quantified by specific scores on the AUDIT and DAST.
Where this trial is running
Créteil
- France — Créteil, France (Recruiting)
Study contacts
- Principal investigator: Marion LEBOYER, MD PhD — Fondation FondaMental
- Study coordinator: Ophélia GODIN, PhD
- Email: ophelia.godain@fondation-fondamental.org
- Phone: 0149813326
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.