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NCT06872398Recruiting

Medical Comorbidities in Bipolar Disorder

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

Source: ClinicalTrials.gov · Last updated 7 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
80 (estimated)
First submitted
22 Apr 2024
Start date
11 Oct 2024
Primary completion date
31 Dec 2025
Lead sponsor
Fondation FondaMental
NCT number
NCT06872398

What you commit to

  • Study type: Observational
  • Planned participants: 80
  • From 11 Oct 2024 to the primary completion date, 31 Dec 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Severe psychiatric comorbidities (schizophrenia spectrum disorders).
  • Severe cognitive impairment.

Other

  • Projected move within the next year.
  • Severe substance or alcohol abuse: quantified by specific scores on the AUDIT and DAST.

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
France
Coordinator of this site? Confirm its status
CréteilFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.