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临床试验/NCT06872398
NCT06872398招募中不适用

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

Fondation FondaMental1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2024年10月11日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
80
试验地点
1
主要终点
Incidence of Metabolic Syndrome (MetS)

研究概览

简要总结

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.

详细描述

WP1: Project Management (Leader: P1-IT)

This WP ensures effective project coordination, quality control, and risk management. It includes:

  • Organizing the Kick-off Meeting (KoM)
  • Managing and monitoring project progress based on predefined indicators
  • Developing a Data Management Plan (DMP) to define data collection, processing, sharing, and storage
  • Addressing ethical issues to ensure compliance with regulations and obtaining necessary authorizations
  • Overseeing risk assessment throughout the project
  • Managing project reporting, including consortium agreements, ethical guidelines, and periodic reports

WP2: Training Set - Register Study (Leader: P3-SE) This WP leverages Swedish and Norwegian national health registries to analyze cases of bipolar disorder (BD) and its comorbidities, particularly metabolic syndrome (MetS).

  • Identification of BD patients from national registries and analysis of co-existing medical conditions
  • Development of machine learning (ML) models to predict MetS and related outcomes
  • Application of ML models using Swedish and Norwegian datasets, validated with genetic data
  • Outputs: Dataset linkage, reports on BD prevalence and comorbidities, risk stratification models, and open-access ML algorithms

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Incidence of Metabolic Syndrome (MetS)

时间窗: 1 year follow-up

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

次要结局

  • Risk Factors for Metabolic Syndrome(1 year follow up)
  • Evolution of Metabolic Syndrome(1 year follow up)

研究者

发起方
Fondation FondaMental
申办方类型
Other
责任方
Sponsor

研究点 (1)

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