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

Technische Universität Dresden

Status

Unknown

Conditions

Affective Dysregulation

Treatments

Drug: Guanfacine

Study type

Observational

Funder types

Other

Identifiers

NCT04016207

IIR-DEU-002258

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

6 to 17 years old

Volunteers

No Healthy Volunteers

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