Hereditary AngioEdema, Neurobiology and Psychopathology
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Multivariate linear regression analysis of HAE clinical status and psychometric parameters
研究概览
简要总结
Since 1963 Hereditary AngioEdema (HAE) is considered an autosomal dominant disorder (Donaldson and Evans), characterized by a quantitative and/or qualitative deficit of C1 esterase inhibitor (C1-INH), which affects approximately 1:50.000 individuals in the general population. From this period the link between HAE and psychiatry was interrupted, however genetic issues could not comprehensively explain the clinical evolution of the disease. Clinical studies show an evident gap between genotype and phenotype of HAE. For this still controversial question, we have designed this cross-sectional study in order to establish the relationship between HAE clinical manifestations and neurobiological/psychopatological parameters.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- 否
入选标准
- •Diagnosis of HAE
排除标准
- •Current pharmacological treatment including ACE-inhibitors, ACE inhibitors, glucocorticoids, oestroprogestative, psychotropic drugs, drugs acting on the immune system (15 days before), anesthetics (in the previous three months).
- •Inflammation / infection (eg, chronic inflammatory diseases, acute) in the last 15 days.
- •Ongoing allergies.
- •Night work over the past 15 days.
- •Vigorous physical activity or alcohol consumption (the day before the assessment).
- •Women in follicular phase of menstrual cycle.
结局指标
主要结局
Multivariate linear regression analysis of HAE clinical status and psychometric parameters
时间窗: First assessment
次要结局
未报告次要终点
研究者
Prof. Eugenio Aguglia
Full Professor of Psychiatry
University Hospital, Catania