Atomoxetine, Diurnal Profiles of Cortisol and α-amylase, Possible Biological Markers of Treatment Success
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- saliva cortisol
研究概览
简要总结
Diurnal profiles of markers of the stress system are increasingly recognized as biomarkers of different kinds of depression and related states. They may also serve as markers of treatment success. However, this has not yet been studied in attention deficit disorder (ADHD). Especially, there is a paucity of research into the effect of ADHD medication on the diurnal profiles of cortisol as marker of the hypothalamic pituitary adrenal (HPA) system and of amylase as marker of the sympathetic adrenomedullar (SAM) system.
The investigators propose a within subjects design with probands of a narrow age range (seven to ten years of age, same sex: boys only) in order to get first information about whether there is an effect of atomoxetine on these diurnal profiles of cortisol and amylase, what kind of effect it is and whether this effect is related to treatment success. The investigators control for motor activity by using actometer measurements.
详细描述
Scientific and clinical Background
There is very good evidence that the hypothalamic-pituitary- adrenal (HPA) axis is disturbed in depression. There is some evidence that the stress system also plays a role in attention deficit disorder (ADHD ) (O'Connor, Heron et al. 2002).
The investigators have shown that motor activity and attention deficit/concentration are core symptoms of depression (Kammerer, Marks et al. 2009; Kammerer 2010). These symptoms are also the core symptoms of attention deficit hyperkinetic disorder (ADHD). There is increasing evidence that the diurnal variation of markers of the stress system (e.g. salivary cortisol for the hypothalamic pituitary adrenal (HPA) axis, salivary amylase for the sympathetic adrenomedullar (SAM) axis) reveal characteristics of different types of depression, e.g. atypical depression (Tops, Riese et al. 2008), post partum depression (Tops, Riese et al. 2008; Taylor, Glover et al. 2009) and related states, e.g. posttraumatic stress disorder (PTSD) (Wessa, Rohleder et al. 2006) and chronic fatigue syndrome (Roberts, Wessely et al. 2004).
There is some evidence that the saliva cortisol levels and the cortisol awakening rise may be markers of treatment success (Roberts, Papadopoulos et al. 2009). Salivary cortisol and salivary amylase are easy to study as only saliva is needed. (Clow, Hucklebridge et al.; Kirschbaum and Hellhammer 1989; O'Donnell, Kammerer et al. 2009). The investigators have tested saliva amylase, found it to be robust and a useful marker for the function of the SAM system (O'Donnell, Kammerer et al. 2009).
However there is still insufficient research into the diurnal profile of cortisol and amylase with children suffering from ADHD. This causes a serious lack of information for both clinical child and adolescent psychiatry and paediatrics as well as for the research community.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 10 Years(Child)
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Boys are eligible, age seven to ten, without comorbid psychiatric and/or somatic condition for whom the responsible paediatrician and/or child psychiatrist gives the indication for treatment with atomoxetine.
排除标准
- •Suicidal risk, depression, history of epileptic seizures, comorbid psychiatric or somatic conditions, history of psychotropic medication.
结局指标
主要结局
saliva cortisol
时间窗: 13 weeks
diurnal profile of saliva cortisol and saliva alpha amylase
次要结局
未报告次要终点
研究者
Martin Kammerer MD PhD
Principal Investigator
Praxis für kleine und grosse Leute
