NCT02888262进行中（未招募）不适用
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 人开始时间: 2016年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Composite blood based biomarker
研究概览
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.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
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)
研究者
Lars Vedel Kessing
Professor, MD, DMSc.
Mental Health Services in the Capital Region, Denmark
研究点 (1)
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