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

April 2, 2020 updated by: PD Dr. med. Robert Waltereit, Technische Universität Dresden

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with the diagnosis of ADHD, Age 6-17 years

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Guanfacin regular treatment
Drug: Guanfacine
regular treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DADYS-EF (Diagnostikum für Affektive Dysregulation, Eltern-Fragebogen)
Time Frame: 9 weeks
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)
Time Frame: 9 weeks
The DADYS is a German instrument to assess affective dysregulation. The Kinder-Fragebogen is the childrens' version of the rating scale.
9 weeks
Conners3L
Time Frame: 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.
9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

Prof. Dr. Veit Roessner and PD Dr. Robert Waltereit jointly lead and conduct the study

Investigators

  • Study Director: Veit Roessner, MD, Technical University Dresden, Child and Adolescent Psychiatry

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2020

Primary Completion (Anticipated)

March 1, 2021

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

July 9, 2019

First Submitted That Met QC Criteria

July 10, 2019

First Posted (Actual)

July 11, 2019

Study Record Updates

Last Update Posted (Actual)

April 6, 2020

Last Update Submitted That Met QC Criteria

April 2, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR-DEU-002258

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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