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Taking people in FranceNo phase

Studies medical health problems in people with bipolar disorder

Collects blood and saliva samples from adults with bipolar disorder to study related medical conditions.

Key facts

Who runs it
Fondation FondaMental
Where
Créteil, FranceSee the site
Trial code
Registry title
Medical Comorbidities in Bipolar Disorder
Status
Recruiting
People taking part
80 people, planned
Started
11 Oct 2024
Expected to end
Dec 2026
Type of study
Observational
Treatments tested
  • Blood and saliva sampling
Record updated
7 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults aged 18 to 65 with bipolar disorder who have been in touch with mental health services in the past year.

Age
18 to 65 years
Sex
Men and women can join.
Disease stage
A main diagnosis of bipolar disorder: BP I, BP II, or BP NOS.
Earlier treatment
At least one contact with mental health services in the past year.

Main reasons for not taking part

  • A planned move within the next year
  • Severe psychiatric conditions of the schizophrenia spectrum
  • Severe cognitive impairment
  • Severe substance or alcohol abuse, measured by specific AUDIT and DAST scores

The registry criteria, word for word

Show all 8 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Severe psychiatric comorbidities (schizophrenia spectrum disorders)
  • Severe cognitive impairment
  • Projected move within the next year
  • Severe substance or alcohol abuse: quantified by specific scores on the AUDIT and DAST

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in France

  • FranceCréteil, FranceContact: Marion LeboyerTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • Bipolar patients

    Individuals diagnosed with bipolar disorder type I (BP I), bipolar disorder type II (BP II), or bipolar disorder not otherwise specified (BP NOS). Eligible participants must be between 18 and 65 years old and have had at least one contact with a mental health service in the past year. All participants will be required to provide signed informed consent before inclusion. Exclusion criteria include severe psychiatric comorbidities such as schizophrenia spectrum disorders, severe cognitive impairment, or severe substance/alcohol abuse, assessed using specific scores on the AUDIT and DAST scales. Patients planning to relocate within the next year will also be excluded.

    Treatment: Blood and saliva sampling

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Medical Comorbidities in Bipolar Disorder : Clinical Validation of Risk Factors and Biomarkers to Improve Prevention and Treatment;
Plain-language title
Studies medical health problems in people with bipolar disorderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06872398, who can take part
Record updated
7 October 2026