Affective Dysregulation (AD) in Children With ADHD Treated by Guanfacin

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Affective Dysregulation

Intervention / Treatment
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* Drug: Guanfacine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: unipolar depression, bipolar disorder, schizophrenia or any other psychotic disorder current substance abuse

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Guanfacin regular treatment<br> | Drug: Guanfacine<br>* regular treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DADYS-EF (Diagnostikum für Affektive Dysregulation, Eltern-Fragebogen) | The DADYS is a German instrument to assess affective dysregulation. The Eltern-Fragebogen is the parents' version of the rating scale. | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DADYS-KF (Diagnostikum für Affektive Dysregulation, Kinder-Fragebogen) | The DADYS is a German instrument to assess affective dysregulation. The Kinder-Fragebogen is the childrens' version of the rating scale. | 9 weeks | 
| Conners3L | The Conners 3rd Edition™ (Conners 3®) is a thorough assessment of attention-deficit/hyperactivity disorder (ADHD) and its most common comorbid problems and disorders in children and adolescents aged 6 to 18 years. It is a multi-informant assessment that takes into account home, social, and school settings, with rating forms for parents, teachers, and youth. | 9 weeks |