The Bipolar Illness Onset Study (the BIO Study)

Mental Health Services in the Capital Region, Denmark1 个研究点分布在 1 个国家目标入组 700 人2016年1月

适应症Bipolar Disorder

概览

阶段: 不适用
干预措施: 未指定
疾病 / 适应症: Bipolar Disorder
发起方: Mental Health Services in the Capital Region, Denmark
入组人数: 700
试验地点: 1
主要终点: Composite blood based biomarker
状态: 进行中（未招募）
最后更新: 2年前

概览研究者入排标准结局指标研究点相似试验

概览

简要总结

This longitudinal study aims to identify 1) a composite blood-based biomarker, 2) a composite electronic Smartphone-based biomarker and 3) a neurocognitive signature for bipolar disorder

详细描述

The study will include 300 patients with newly diagnosed/first episode bipolar disorder, 200 healthy siblings or child family members and 100 healthy individuals without a family history of affective disorder. All individuals will be investigated with repeated blood tests, Smartphone recordings, neuropsychological tests and brain imaging during a five to ten year study period.

注册库

clinicaltrials.gov

开始日期

2016年1月

结束日期

2026年12月

最后更新

2年前

研究类型

Observational

性别

All

研究者

发起方

Mental Health Services in the Capital Region, Denmark

责任方

Principal Investigator

主要研究者

Lars Vedel Kessing

Professor, MD, DMSc.

Mental Health Services in the Capital Region, Denmark

入排标准

入选标准

•Newly diagnosed/first episode bipolar patients,
•First-generation relatives (siblings and children aged 15 to 40 years) to the recruited newly diagnosed/first episode bipolar patients.
•Age- and gender matched sample of healthy individuals without a first-generation family history of effective disorders

排除标准

•Significant physical disorders
•Schizophrenia or related disorders

结局指标

主要结局

Composite blood based biomarker

时间窗: 5 years

次要结局

Composite smartphone based biomarker including self reported and smartphone generated data(5 years)
Composite neurocognitive marker including "Cold" and "Hot" cognition.(5 years)