RecruitingNCT06872398

Medical Comorbidities in Bipolar Disorder

Medical Comorbidities in Bipolar Disorder : Clinical Validation of Risk Factors and Biomarkers to Improve Prevention and Treatment;


Sponsor

Fondation FondaMental

Enrollment

80 participants

Start Date

Oct 11, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria4

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERBlood and saliva sampling

Physical and biological evaluation at inclusion visit V0 and at follow up visit V1 (after 1 year). the biological evaluation includes blood and saliva sampling at the 2 visits.


Locations(1)

France

Créteil, France

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06872398


Related Trials