Trial document




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  DRKS00003112

Trial Description

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Title

Cognitive Hyper-performance – Effects of Stimulating Substances in chess-players

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Trial Acronym

CHESS

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Aim of this study is to elucidate the effects of caffeine, methylphenidate and modafini on cognitive performance in chess players. It is a randomized placebo-controlled double-blind trial with cross-over design in phase I. Aim of this study is to elucidate effects of psychotropic substances on simple and complex cognitive performance.

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Brief Summary in Scientific Language

Effects of caffeine, methylphenidate and modafini on cognitive performance in chess players. A randomized placebo-controlled double-blind trial with cross-over design in phase I

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Organizational Data

  •   DRKS00003112
  •   2011/05/26
  •   [---]*
  •   yes
  •   Approved
  •   837-113-10 (7122), Ethik-Kommission bei der Landesärztekammer Rheinland-Pfalz
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Secondary IDs

  •   U1111-1121-7635 
  •   2009-012851-33 
  •   4036440 
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Health Condition or Problem studied

  •   healthy subjects
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Interventions/Observational Groups

  •   Caffeine (Coffeinum) 2x 200 mg in tablets (2. application 4 hours after first application)
  •   Methylphenidat (Ritalin) 2x 20 mg in tablets (2. application 4 hours after first application)
  •   Modafinil (Vigil) 2x 200 mg in tablets (2. application 4 hours after first application
  •   Placebo
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Double or multiple blind
  •   patient/subject, therapist/clinician, assessor
  •   Placebo
  •   Basic research/physiological study
  •   Crossover
  •   I
  •   [---]*
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Primary Outcome

Primary outcome is the results of chess games measured by the number of games (win, lose, tie) under the influence of caffeine, methylphenidate, modafinil and placebo for elucidating cognitive effects of the used substances.

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Secondary Outcome

Secondary outcome for the cognitive effectiveness of methylphenidate, modafinil and caffeine is:
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time until decision of chess game(s)
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outcome of neurcognitive standardized tests (Tower of Hanoi, Trail-Making-Test, Stroop-Test, Psycho-Motor-Vigilanz-Test, Wisconsin-Card-Sorting-Test, Balloon Analog Risk Task)
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measuring of risk taking behaviour motivation, mood and subjective substance effects using standardized questionnaires (Evaluation of Risk Task EVAR, Profile of Mood Status POMS, Achievement Motive Scale AMS, Drug Effects Questionnaire DEQ)
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adverse events
AEs are monitored during day of trial and one day later

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/05/15
  •   40
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   60   Years
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Additional Inclusion Criteria

Inculsion criteria:
- male
- healthy
- 18. – 60. years old
- existing ELO-Number/ DWZ (Deutsche Wertungszahl)

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Exclusion Criteria

Exclusion criteria:
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existing somatic disease (e.g. Diabetes mellitus, known Liver- and kidney disease with necessity of use of prescription drugs
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existing psychiatric disease (actual, past) (e.g. organic psychiatric diseases, Alzheimer´s disease, bipolar disorders, addiction, schizophrenia) with the necessity of use of prescription drugs
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addiction of psychoactive substances actual and in the past
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smoker and quitter (< 5 years)
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use of coffee > 5 cups per day
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people with unregular day- and night-sleep (e.g. shift worker)

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Psychiatrie und Psychotherapie
    • Mr.  Prof. Dr. med.  Klaus  Lieb 
    • Untere Zahlbacher Str. 8
    • 55131  Mainz
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie
    • Andreas  Franke 
    • Untere Zahlbacher Str. 8
    • 55131  Mainz
    • Germany
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    • Internistische Praxis und Präsident des Hessischen Schachverbande
    • Mr.  Dr.  Harald  Ballo 
    • Marktplatz 11
    • 63065  Offenbach am Main
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychiatrie und Psychotherapie
    • Mr. 
    • Untere Zahlbacher Str. 8
    • 55131  Mainz
    • Germany
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    •   06131-17-2920
    •   06131-17-6690
    •   [---]*
    •   [---]*
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Status

  •   Recruiting complete, follow-up complete
  •   2013/05/16
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Trial Publications, Results and other Documents

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