NCT06872398 Medical Comorbidities in Bipolar Disorder
| NCT ID | NCT06872398 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation FondaMental |
| Condition | Psychiatric Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-10-11 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2024-10-11 with a primary completion date of 2025-12.
⚠ 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
Bipolar Disorder (BD) is a common, heritable, chronic, and recurrent disorder that represents a critical public health problem, due to its prevalence, its high degree of disability and psychiatric and MC (MC): these represent a significant additive burden for BD patients, with a large clinical heterogeneity and an urgent need for personalised treatment and management. BIPCOM overarching purpose is to study MC in people with BD and to improve diagnostic and treatment outcomes with a precision medicine approach targeting 3 objectives: (1) to identify prevalence rates, risk and protective factors and natural history of MC among subjects with BD, through analyses of the Nordic biobanks and medical registers Work Package WP(WP2) and a cross- sectional study exploiting existing datasets of patients with BD (WP3); (2) to conduct an Exploratory Clinical Study (ECS - WP4) involving 400 subjects (80 X 5 recruiting sites), to assess the overall clinical profile of these patients and quantify the 1-year incidence of specific risk factors for the onset of metabolic syndrome (MetS) (WP5); (3) to develop a Clinical Support Tool (CST), including a set of recommendations, to support individualized clinical decision-making in BD comorbidity management and improve prevention, early detection and effective treatment, while ensuring the translation of project results' into clinical practice (WP5 and 6). BIPCOM will be implemented through continuous consultations with stakeholders (scientific and patients' associations, users and families), for ensuring results' acceptability and transferability. The successful implementation of the project will have a significant impact upon the general health of people with BD, eventually leading to lower mortality rates and reduced incidence of severe disabilities, whilst providing reliable methods and tools for patients' stratification and personalized treatments.
Eligibility 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.
Contact & Investigator
Marion LEBOYER, MD PhD
PRINCIPAL INVESTIGATOR
Fondation FondaMental
Frequently Asked Questions
Who can join the NCT06872398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Psychiatric Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06872398 currently recruiting?
Yes, NCT06872398 is actively recruiting participants. Contact the research team at ophelia.godain@fondation-fondamental.org for enrollment information.
Where is the NCT06872398 trial being conducted?
This trial is being conducted at Créteil, France.
Who is sponsoring the NCT06872398 clinical trial?
NCT06872398 is sponsored by Fondation FondaMental. The principal investigator is Marion LEBOYER, MD PhD at Fondation FondaMental. The trial plans to enroll 80 participants.