Trial document




drksid header

  DRKS00007811

Trial Description

start of 1:1-Block title

Title

Generation of random numbers in young patients suffering from ADHD

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

[---]*

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

[---]*

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

The random number generation task (RNGT) is a cognitive task assessing the ability to generate random single numbers for a few minutes in humans. While such a generation of numbers is perceived as random by the participant, certain cognitive abilities determine the produced series of numbers – especially working memory processes are highly involved in this task. Studies with patients suffering from Parkinson disease revealed deviant RNGT patterns reflecting deficits in working memory processes. Patients with ADHD are known to display deficits in working memory tasks, as well. Both patient groups are characterized by deficits in dopaminerg signaling, but in different brain regions (fronto-striatal circuits in ADHD, nigro-striatal circuits in Parkinson). This study is aimed to investigate a) whether young patients with ADHD show deficits in working memory sensitive RNGT performance and b) we intend to discover disease-specific RNGT performance patterns that might help to distinguish between patients with ADHD and Parkinson on behavioral level. To control for possible effects of age and development, healthy children will be included.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00007811
  •   2015/02/13
  •   [---]*
  •   yes
  •   Approved
  •   D 402/15, Ethikkommission der Christian-Albrechts-Universität zu Kiel
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F90.0 -  Disturbance of activity and attention
  •   F90.1 -  Hyperkinetic conduct disorder
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Patients suffering from ADHD will be asked for five minutes to generate every second a number between 1 and 9.
  •   Healthy controls will be asked for five minutes to generate every second a number between 1 and 9.
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

We expect that patients with ADHD display comparable deficits in global working memory capacity as observed in Parkinson patients. The global memory score is measured by the „prediction rate decay“. At the same time we expect that patients suffering from ADHD when compared with healthy controls will show worse cognitive monitoring functions. Monitoring functions, measured by the prediction rate, are primary associated with frontal brain functions and were undisturbed in Parkinson´s disease.

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

not defined

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2015/02/12
  •   80
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Male
  •   8   Years
  •   18   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

In patients: F90.0 F90.1 diagnose

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

For all participants: sub average intelligence quotient, further diseases, and medicine intake; for patients in case of medicination with methylphenidate: 48 h wash out time

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Kinder- und Jugendpsychiatrie und -psychotherapieZentrum für Integrative PsychiatrieUniversitätsklinikum Schleswig-Holstein, Kiel
    • Mr.  Dr. rer. nat.  Alexander  Prehn-Kristensen 
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0431 9900 2531
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik für Kinder- und Jugendpsychiatrie und -psychotherapieZentrum für Integrative PsychiatrieUniversitätsklinikum Schleswig-Holstein, Kiel
    • Mr.  Dr. rer. nat.  Alexander  Prehn-Kristensen 
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Kinder- und Jugendpsychiatrie und -psychotherapieZentrum für Integrative PsychiatrieUniversitätsklinikum Schleswig-Holstein, Kiel
    • Mr.  Dr. rer. nat.  Alexander  Prehn-Kristensen 
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Kinder- und Jugendpsychiatrie und -psychotherapieZentrum für Integrative PsychiatrieUniversitätsklinikum Schleswig-Holstein, Kiel
    • Mr.  Dr. rer. nat.  Alexander  Prehn-Kristensen 
    • Niemannsweg 147
    • 24105  Kiel
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0431 9900 2531
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting ongoing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.