Trial document





This trial has been registered retrospectively.
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  DRKS00014922

Trial Description

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Title

Pathophysiology during neural information processing in ADHD

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Trial Acronym

[---]*

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URL of the Trial

http://neurologie-psychiatrie.uk-koeln.de/psychiatrie-und-psychotherapie/forschung/arbeitsgruppen/kognitive-neurophysiologie/projekte/projekte-arbeitsgruppe-kognitive-neurophysiologie

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Brief Summary in Lay Language

Main scientific questions
1) Does the treatment of ADHD with methylphenidate lead to changes in neuronal activity?
2) Do the changes in neuronal activity specifically correspond to the duration of medication?
3) How is the neuronal activity related to psychopathological, socio-functional, and psychological parameters?

What is done:
Diagnosis, anamnesis, demography, psychopathology, neuropsychology, EEG

Study participants:
Age: 18-45 years of age with a diagnosis of ADHD

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Brief Summary in Scientific Language

Scientific research on neuronal activity in ADHD post medication

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Organizational Data

  •   DRKS00014922
  •   2018/07/18
  •   [---]*
  •   yes
  •   Approved
  •   16-468, Ethik-Kommission der Medizinischen Fakultät der Universität zu Köln
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F90 -  Hyperkinetic disorders
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Interventions/Observational Groups

  •   This is a non-interventional study (EEG, neuropsychological testing, interview), which is independent of the clinical drug treatment with methylphenidate.

    Amendment 1: unmedicated adult patients

    Amendment 2: medicatetd adult patients

    Accompanying research (Nicht-AMG, Nicht-MPG) for
    a) Amendment 1: threefold examination - i) pre, ii) at least 4 weeks after start of medication, iii) 6 month after start of medication
    b) Amendment 2: twofold examination - i) medicated ii) during a withdrawal trial
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Basic research/physiological study
  •   Single (group)
  •   N/A
  •   No
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Primary Outcome

Evidence of specific changes in the EEG relative to medication

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Secondary Outcome

Relationship between EEG parameters, dosage of medication, neuropsychology and interviews on the current condition (ADHS-E, Wender Utah Rating Scale short form (WURS-K), Wender-Reimherr-Interview (WRI-V), Testbatterie zur Aufmerksamkeitsprüfung (TAP))

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
  • Doctor's Practice 
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Recruitment

  •   Actual
  •   2017/11/20
  •   32
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

Amendment 1+2:
1) Age 18-45
2) Sufficient understanding of the German language for the questionnaire survey
3) Written informed consent of patients
4) Diagnosis of ADHD according to ICD-10
5) Clinically indicated treatment with methylphenidate
6) Stable psychotropic medication (except ADHD medication) for at least 4 weeks

Amendment 1:
unmedicated, concerning methylphenidate

Amendment 2:
Medicated for at least 6 months with methylphenidate


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Exclusion Criteria

1. known neurological disorders affecting the brain, including condition after craniocerebral trauma with unconsciousness greater than 5 minutes
2. harmful substance use according to ICD-10
3. taking antipsychotics up to 4 weeks before baseline and during the examination period

For Amendment 1:
4. taking pharmaceuticals for ADHD treatment on the day of the examination (not extended release) or within 48 hours (extended release and atomoxetine) before baseline
For Amendment 2:
4. taking pharmaceuticals for ADHD treatment on the day of the examination (not extemded release) or within 48 hours (extended release and atomoxetine) before baseline, with the exception of methylphenidate

5. motor hyperactivity at the time of measurement that makes an EEG examination impossible
6. known IQ < 70
7. premature birth < 32 wks

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Addresses

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    • Klinik für Psychiatrie und Psychotherapie der Uniklinik Köln
    • Kerpener Straße 62
    • 50937  Köln
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie der Uniklinik Köln
    • Mr.  Dr. med.  Daniel  Huys 
    • Kerpener Straße 62
    • 50924  Köln
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie der Uniklinik Köln
    • Mr.  Dipl. Math.  Ralf  Müller 
    • Kerpener Straße 62
    • 50924  Köln
    • Germany
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Sources of Monetary or Material Support

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    • Bundesinstitut für Arzneimittel und Medizinprodukte
    • Kurt-Georg-Kiesinger-Allee 3
    • 53175  Bonn
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie der Uniklinik Köln
    • Mr.  Dr. med.  Daniel  Huys 
    • Kerpener Straße 62
    • 50924  Köln
    • Germany
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Status

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

  • [---]*
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* This entry means the parameter is not applicable or has not been set.