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临床试验/NCT03075579
NCT03075579Unknown不适用

Atomoxetine, Diurnal Profiles of Cortisol and α-amylase, Possible Biological Markers of Treatment Success

Praxis für kleine und grosse Leute2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年12月1日最近更新:
适应症
相关药物

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

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

发起方
Praxis für kleine und grosse Leute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Martin Kammerer MD PhD

Principal Investigator

Praxis für kleine und grosse Leute

研究点 (2)

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