Medical Comorbidities in Bipolar Disorder

NCT06872398 | Recruiting

• 1 other identifier: 2023-A02218-37
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of Metabolic Syndrome (MetS)

  Number of bipolar patients meeting MetS criteria (≥3 of 5 criteria)

  1 year follow-up

Secondary Outcomes (2)

• Risk Factors for Metabolic Syndrome

  1 year follow up

• Evolution of Metabolic Syndrome

  1 year follow up

Study Arms (1)

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.

Other: Blood and saliva sampling

Interventions

Blood and saliva sampling OTHER

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.

Bipolar patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

To ensure representation, BP patients will be stratified by age, sex, and disorder severity. Subjects will be divided into 8 groups, with 5 patients randomly selected from each group, totaling 20 men, 20 women, 20 subjects aged 18-45, 20 aged 46-65, 20 with severe BP, and 20 with non-severe BP.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondation FondaMental: lead

Study Sites (1)

France

Créteil, 94000, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

The BIPCOM study will assess metabolic and inflammatory biomarkers in bipolar disorder. Core biomarkers include adiponectin/leptin ratio, ALT, AST, blood count, C-peptide, fasting glucose, GGT, HDL-cholesterol, hsCRP, oxidized LDL, and triglycerides. Additional biomarkers, such as albumin, cystatin-C, IL-6, IL-10, LDL-cholesterol, salivary cortisol, serum amyloid A, testosterone, thyroid antibodies, TNF-α, total cholesterol, TSH, uric acid, and ghrelin, will provide further insights into systemic inflammation, oxidative stress, lipid metabolism, and cardiovascular risk. This analysis aims to enhance understanding of metabolic comorbidities in bipolar disorder

MeSH Terms

Conditions

Mental Disorders

Interventions

Blood Specimen Collection

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Marion LEBOYER, MD PhD

  Fondation FondaMental

  PRINCIPAL INVESTIGATOR

• Ophélia GODIN, PhD

  Institut National de la Santé Et de la Recherche Médicale, France

  STUDY DIRECTOR

Central Study Contacts

Ophélia GODIN, PhD

CONTACT

0149813326; ophelia.godain@fondation-fondamental.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: March 12, 2025
• Study Start: October 11, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)