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

• Conditions: Affective Dysregulation
• Interventions: Drug: Guanfacine

• Registration Number: NCT04016207
• Lead Sponsor: Technische Universität Dresden

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-07-09
• Study First Submitted QC: 2019-07-10
• Study First Posted: 2019-07-11
• Status Verified: 2020-04
• Study Start: 2020-04-01
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-06
• Primary Completion: 2021-03
• Study Completion: 2021-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Guanfacin regular treatment	Guanfacine	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
DADYS-KF (Diagnostikum für Affektive Dysregulation, Kinder-Fragebogen)	9 weeks	The DADYS is a German instrument to assess affective dysregulation. The Kinder-Fragebogen is the childrens' version of the rating scale.
Conners3L	9 weeks	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.