Trial document



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  DRKS00016970

Trial Description

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Title

Serotonergic Modulation of Waiting Impulsivity- a translational study in mice and men

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Trial Acronym

Tph2_Wl

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URL of the Trial

http://none

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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.

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Organizational Data

  •   DRKS00016970
  •   2019/04/17
  •   [---]*
  •   yes
  •   Approved
  •   2018-306-Drittmittel, Ethik-Kommission an der Medizinischen Fakultät der Heinrich-Heine-Universität Düsseldorf
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Secondary IDs

  •   2018-114-851  (Studienregister des Universitätsklinikums Düsseldorf)
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Health Condition or Problem studied

  •   F90 -  Hyperkinetic disorders
  •   ANXIETY AGGRESSIVENESS
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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.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Other
  •   N/A
  •   N/A
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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.

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2019/07/01
  •   150
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   18   Years
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Additional Inclusion Criteria

general criteria are:
IQ > 80
aged from 8-18 years

For ADHD patients:
F90 diagnosis, commorbidities are okay

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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

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Addresses

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    • Universitätsklinikum Düsseldorf
    • Moorenstr. 5
    • 40225  Düsseldorf
    • Germany
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    • 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
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    • 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
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Sources of Monetary or Material Support

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    • Deutsche Forschungsgemeinschaft
    • Kennedyallee 40
    • 53175  Bonn
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

  •   ethical vote
  •   Studienprotokoll
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* This entry means the parameter is not applicable or has not been set.