Biomarkers for Pharmacoresponse in Bipolar Disorder - Coagulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Extracellular vesicles
研究概览
简要总结
Previous studies indicate an association between severe psychiatric disorders, such as bipolar disorder, and increased risk of venous thromboembolism. However, to which extent this association is influenced by lithium treatment is currently unknown. In this prospective cohort study, the investigators aim to investigate the effect of bipolar disorder and lithium treatment on coagulation and the counterpart fibrinolysis.
详细描述
The investigators will analyse differences in coagulation
- using a case-control design where cases are bipolar patients not yet treated with lithium, and controls are healthy volunteers (Swedish ethical review authority Dnr 2023-05799-02, PI Kristoffer Månsson, KI).
- using a prospective cohort design, following the patients over time.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with bipolar disorder but not yet treated with lithium, where there is a decision by the patient and the responsible doctor to start lithium treatment.
排除标准
- •Inability to give informed consent
结局指标
主要结局
Extracellular vesicles
时间窗: From enrollment to end of examination at 2 years
Counts of plasma extracellular vesicles originating from blood platelets, leukocytes and vascular endothelial cells.
Hemostatic potential
时间窗: From enrollment to end of examination at 2 years
Overall hemostatic potential (OHP), coagulation potential (OCP) fibrinolytic potential (OFP) i citrate plasma.
次要结局
未报告次要终点
研究者
Catharina Lavebratt Holmquist
Research group leader
Karolinska Institutet