Trial document
DRKS00016970
Trial Description
Title
Serotonergic Modulation of Waiting Impulsivity- a translational study in mice and men
Trial Acronym
Tph2_Wl
URL of the Trial
Brief Summary in Lay Language
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Brief Summary in Scientific Language
Attention-Deficit Hyperactivity Disorder (ADHD) is a heterogeneous disease that frequently presents with co-occurring psychiatric disorders, e.g. conduct disorder and anxiety. By bridging the fields of basic research and clinical science, translational studies have increasingly gained importance, nurturing our understanding of the underlying mechanisms of comorbidities and exploring novel treatment perspectives. In the case of the serotonin-catalizing tryptophan hydroxylase-2 (TPH2) gene, the null mutant mice (Tph2-/-) have been discussed as candidate model for ADHD. Variants of the TPH2 gene have been associated with ADHD, increased impulsive behavior, increased aggression and altered anxiety behavior.
Derived from the combined phenotypic alterations in anxiety, impulsivity and aggression in the TPH2 KO mouse model and clinical findings, the aim of this study is to quantify these phenotypic dimensions in a clinical pediatric sample of 250 ADHD patients and typically developing children. All participants will be (a) genotyped for the TPH2 (G-703T; rs4570625) variant, (b) phenotyped for impulsivity, aggression and anxiety as suggested by the international Research Domain Criteria (RDoC) and (c) examined using the 5-choice serial reaction time task in the fMRI scanner. In a second step, the mediating and moderating interaction of the dimensional phenotypes will be characterized by clinical, behavioral and neural parameters.
Using an adapted version of the reverse phenotyping approach, this study will provide insight into the mechanisms of phenotypic complexity in comorbid disorders associated with ADHD. Broader societal, political and scientific impact may be expected from the findings in terms of developing age-adapted targeted intervention and prevention programs in ADHD.
Organizational Data
- DRKS00016970
- 2019/04/17
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- yes
- Approved
- 2018-306-Drittmittel, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
Secondary IDs
- 2018-114-851 (Studienregister des Universitätsklinikums Düsseldorf)
Health Condition or Problem studied
- F90 - Hyperkinetic disorders
- ANXIETY AGGRESSIVENESS
Interventions/Observational Groups
-
In this cross-sectional study, 250 children and adolescents with and without ADHD are examined. A dimensional approach as suggested by the rDoC is applied.
Using fMRI we examine the influence of anxiety and aggression on impulsivity by correlating trait anxiety and aggression with behavioral, neural and connectivity parameters of an impulsivity task. Study duration is 3 years. - In this study we follow the dimensional approach as suggested by the rDoC. Therefore, patients and controls are pooled in one group. We will not perform goup comparisons.
Characteristics
- Non-interventional
- Other
- Other
- Open (masking not used)
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- Other
- Basic research/physiological study
- Other
- N/A
- N/A
Primary Outcome
The study, or better data acquisition of fMRI and questionnaire data will end when the calculated minimal sample size of n=250 is reached. The financial support will end in summer 2021.
Secondary Outcome
/
Countries of Recruitment
- Germany
Locations of Recruitment
- University Medical Center
Recruitment
- Planned
- 2019/07/01
- 150
- Monocenter trial
- National
Inclusion Criteria
- Both, male and female
- 8 Years
- 18 Years
Additional Inclusion Criteria
general criteria are:
IQ > 80
aged from 8-18 years
For ADHD patients:
F90 diagnosis, commorbidities are okay
Exclusion Criteria
general criteria are:
no current neurological disease
no metal body implants (Retainer, Bracelets etc.)
For healthy controls:
no current or history of neurological and psychiatric diseases, no family history of neurological and psychiatric disease
Addresses
-
start of 1:1-Block address primary-sponsor
- Universitätsklinikum Düsseldorf
- Moorenstr. 5
- 40225 Düsseldorf
- Germany
end of 1:1-Block address primary-sponsorstart of 1:1-Block address contact primary-sponsor- [---]*
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- http://www.uniklinik-duesseldorf.de
end of 1:1-Block address contact primary-sponsor -
start of 1:1-Block address scientific-contact
- Klinik und Poliklinik für Psychiatrie und Psychotherapie, LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
- Ms. PD Dr. rer. nat. Susanne Neufang
- Bergische Landstraße 2,
- 40629 Düsseldorf
- Germany
end of 1:1-Block address scientific-contactstart of 1:1-Block address contact scientific-contact- +49 0211 922 - 2795
- +49 0211 922 - 2709
- susanne.neufang at lvr.de
- https://klinikum-duesseldorf.lvr.de/
end of 1:1-Block address contact scientific-contact -
start of 1:1-Block address public-contact
- Klinik und Poliklinik für Psychiatrie und Psychotherapie, LVR-Klinikum Düsseldorf Kliniken der Heinrich-Heine-Universität Düsseldorf
- Ms. PD Dr. rer. nat. Susanne Neufang
- Bergische Landstraße 2,
- 40629 Düsseldorf
- Germany
end of 1:1-Block address public-contactstart of 1:1-Block address contact public-contact- +49 0211 922 - 2795
- +49 0211 922 - 2709
- susanne.neufang at lvr.de
- https://klinikum-duesseldorf.lvr.de/
end of 1:1-Block address contact public-contact
Sources of Monetary or Material Support
-
start of 1:1-Block address materialSupport
- Deutsche Forschungsgemeinschaft
- Kennedyallee 40
- 53175 Bonn
- Germany
end of 1:1-Block address materialSupportstart of 1:1-Block address contact materialSupport- [---]*
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- http://www.dfg.de
end of 1:1-Block address contact materialSupport
Status
- Recruiting planned
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