Affective Dysregulation (AD) in Children With ADHD Treated by Guanfacin
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
1 other identifier
observational
40
0 countries
N/A
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.
Trial Health
Trial Health Score
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participants targeted
Target at P25-P50 for all trials
Started Apr 2020
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedStudy Start
First participant enrolled
April 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedApril 6, 2020
April 1, 2020
11 months
July 9, 2019
April 2, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
DADYS-KF (Diagnostikum für Affektive Dysregulation, Kinder-Fragebogen)
9 weeks
Conners3L
9 weeks
Study Arms (1)
Guanfacin regular treatment
Interventions
Eligibility Criteria
Patients with the diagnosis of ADHD, Age 6-17 years
You may qualify if:
- 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
- IQ must be at least 70
- Patients receiving or intended to receive Guanfacin
- Written informed consent by the custodian and the children
You may not qualify if:
- unipolar depression, bipolar disorder, schizophrenia or any other psychotic disorder
- current substance abuse
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Waltereit J, Uhlmann A, Tarassidis C, Preuss U, Roessner V, Waltereit R. Treatment of affective dysregulation in ADHD with guanfacine: study protocol. Front Child Adolesc Psychiatry. 2025 Mar 28;4:1547672. doi: 10.3389/frcha.2025.1547672. eCollection 2025.
PMID: 40226438DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Veit Roessner, MD
Technical University Dresden, Child and Adolescent Psychiatry
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultant
Study Record Dates
First Submitted
July 9, 2019
First Posted
July 11, 2019
Study Start
April 1, 2020
Primary Completion
March 1, 2021
Study Completion
June 1, 2021
Last Updated
April 6, 2020
Record last verified: 2020-04