Status:
UNKNOWN
Affective Dysregulation (AD) in Children With ADHD Treated by Guanfacin
Lead Sponsor:
Technische Universität Dresden
Collaborating Sponsors:
Prof. Dr. Veit Roessner and PD Dr. Robert Waltereit jointly lead and conduct the study
Conditions:
Affective Dysregulation
Eligibility:
All Genders
6-17 years
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 con...
Eligibility Criteria
Inclusion
- 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
- unipolar depression, bipolar disorder, schizophrenia or any other psychotic disorder
- current substance abuse
Key Trial Info
Start Date :
April 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04016207
Start Date
April 1 2020
End Date
June 1 2021
Last Update
April 6 2020
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