Affective DysregulationNCT04016207
Affective Dysregulation (AD) in Children With ADHD Treated by Guanfacin
An observational study of Affective Dysregulation, run by Technische Universität Dresden.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Affective Dysregulation
- What is being tested?
- Guanfacine
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients with the diagnosis of ADHD, Age 6-17 years
Who may be able to join
- 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
Who cannot join
- unipolar depression, bipolar disorder, schizophrenia or any other psychotic disorder
- current substance abuse
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
- Conditions
- Affective Dysregulation
- Being tested
- Guanfacine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GuanfacineDrug
regular treatment
| Study group | Role | What they receive |
|---|---|---|
| Guanfacin regular treatment | Not described Receives: Drug: Guanfacine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 weeks
Secondary outcomes (2)
DADYS-KF (Diagnostikum für Affektive Dysregulation, Kinder-Fragebogen)
The DADYS is a German instrument to assess affective dysregulation. The Kinder-Fragebogen is the childrens' version of the rating scale.
Measured: 9 weeks
Conners3L
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.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2019
- Study start1 Apr 2020 (estimated)
- Primary completionMar 2021 (estimated)
- Study completionJun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Affective DysregulationStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Collaborators
- Prof. Dr. Veit Roessner and PD Dr. Robert Waltereit jointly lead and conduct the study
- Responsible party
- Principal investigator, PD Dr. med. Robert Waltereit, Technische Universität Dresden
- Investigators
- Veit Roessner, MD, Study director, Technical University Dresden, Child and Adolescent Psychiatry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04016207
- Sponsor's protocol ID
- IIR-DEU-002258
- Status last verified
- Apr 2020
- First submitted
- 9 Jul 2019
- Last updated
- 6 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 40226438
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04016207
- Acronym / sponsor ID
- IIR-DEU-002258
- Conditions
- Affective Dysregulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Collaborators
- Prof. Dr. Veit Roessner and PD Dr. Robert Waltereit jointly lead and conduct the study
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Jun 2021 (estimated)
- First posted
- 11 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guanfacin regular treatment | – | Drug: Guanfacine |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients with the diagnosis of ADHD, Age 6-17 years
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- unipolar depression, bipolar disorder, schizophrenia or any other psychotic disorder
- current substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guanfacineregular treatment | Drug | Guanfacin regular treatment |
Primary outcome
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.
2 secondary outcomes
DADYS-KF (Diagnostikum für Affektive Dysregulation, Kinder-Fragebogen)
Time frame: 9 weeks
Conners3L
Time frame: 9 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2020.
- Derived from this study: PubMed 40226438Waltereit 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Veit Roessner, MD study director
Technical University Dresden, Child and Adolescent Psychiatry
Questions about this trial
What is this clinical trial studying?
An observational study of Affective Dysregulation, run by Technische Universität Dresden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Robert Waltereit, MD (+493514582244, robert.waltereit@uniklinikum-dresden.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DADYS-EF (Diagnostikum für Affektive Dysregulation, Eltern-Fragebogen) (time frame: 9 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04016207, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2020.