Non-interventional Trial to Investigate the Change of Psychopathological Markers of Affective Dysregulation (AD) in Children With Attention Deficit Hyperactivity Disorder (ADHD) Treated by Guanfacin, a Pilot Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 主要终点
- DADYS-EF (Diagnostikum für Affektive Dysregulation, Eltern-Fragebogen)
研究概览
简要总结
Early onset, high prevalence and persistence, as well as developmental comorbidity make affective dysregulation (AD) in childhood one of the most psychosocially impairing and cost-intensive mental conditions. Despite continuous research, there is still a substantial need for optimization of individual treatment strategies in order to improve outcomes and to reduce subjective and economic burden. Here we want to study the change of psychopathological markers of affective dysregulation (AD) treatment of affective dysregulation (AD) in children with Attention Deficit Hyperactivity Disorder (ADHD) treated by Guanfacine. These children did not respond to methylphenidate treatment. The results will allow the generation of a hypothesis for a randomized clinical trial to investigate the efficacy and safety of Guanfacine for the treatment of AD in children.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female patients (aged 6 to 17 years)
- •clinical diagnosis of ADHD (F90.0) or comorbid ADHD and Oppositional defiant disorder (ODD) (F90.1)
- •patients with ADHD who did not respond to stimulants
- •DADYS is an instrument to assess AD and has a domain for disruptive behaviors. Inclusion criterion for the study is a score of at least moderate (middle) severity in the DADYS parents version this domain
- •IQ must be at least 70
- •Patients receiving or intended to receive Guanfacin
- •Written informed consent by the custodian and the children
排除标准
- •unipolar depression, bipolar disorder, schizophrenia or any other psychotic disorder
- •current substance abuse
研究组 & 干预措施
Guanfacin regular treatment
干预措施: Guanfacine (Drug)
结局指标
主要结局
DADYS-EF (Diagnostikum für Affektive Dysregulation, Eltern-Fragebogen)
时间窗: 9 weeks
The DADYS is a German instrument to assess affective dysregulation. The Eltern-Fragebogen is the parents' version of the rating scale.
次要结局
- DADYS-KF (Diagnostikum für Affektive Dysregulation, Kinder-Fragebogen)(9 weeks)
- Conners3L(9 weeks)
研究者
PD Dr. med. Robert Waltereit
Consultant
Technische Universität Dresden