- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01834547
Cognitive Hyper-performance - Effects of Stimulating Substances in Chess-players (CHESS)
April 17, 2013 updated by: K. Lieb
Phase I Study About Effects of Caffeine, Methylphenidate, Modafinil and Placebo on Cognitive Performance of Chess Players.
Effects of caffeine, methylphenidate, modafinil and placebo on cognitive performance of chess players in chess games and neuropsychiatric standardized tests.
We hypothesize that substances will change cognitive performance in chess players leading to changed results in chess games and neuropsychiatric tests.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Mainz, Germany, 55131
- Department of Psychiatry and Psychotherapy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- male
- 18-60 years old
- existence of ELO-number
Exclusion Criteria:
- physical diseases (e.g. diabetes mellitus, etc.) with necessity of using prescription drugs
- psychiatric diseases (e.g. psychosis, bipolar disorders, etc.) with necessity of using prescription drugs
- addiction of psychoactive substances
- smoker or quitter (< 5 years)
- use of more than 5 cups of coffee per day
- irregular day-night-rhythm (e.g. shift workers)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: placebo
|
placebo
|
|
Experimental: Methylphenidate
|
40 mg tablets
|
|
Experimental: modafinil
|
40 mg tablets
|
|
Experimental: caffeine
|
400 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Chess games (win/ lose/ tie)
Time Frame: two years
|
two years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
time period for decision of chess games
Time Frame: results of ches games
|
results of ches games
|
|
Cognitive performance measured with standardized neuropsychiatric tests (Tower of Hanoi, Trail-Making test, Stroop-Test, Psycho-Motor-Vigilance test, Wisconsin-Card-Sorting-Test, Balloon Analog Risk Task)
Time Frame: outcome of tests
|
outcome of tests
|
|
measuring of risk taking behaviour, motivation, mood using standardized questionnaires
Time Frame: outcome of tests
|
outcome of tests
|
|
adverse events
Time Frame: type of adverse events
|
type of adverse events
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2011
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
May 25, 2011
First Submitted That Met QC Criteria
April 17, 2013
First Posted (Estimate)
April 18, 2013
Study Record Updates
Last Update Posted (Estimate)
April 18, 2013
Last Update Submitted That Met QC Criteria
April 17, 2013
Last Verified
April 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Purinergic Antagonists
- Purinergic Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Dopamine Uptake Inhibitors
- Phosphodiesterase Inhibitors
- Purinergic P1 Receptor Antagonists
- Central Nervous System Stimulants
- Wakefulness-Promoting Agents
- Methylphenidate
- Caffeine
- Modafinil
Other Study ID Numbers
- 1234 (Department of Defense)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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