NCT01834547

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started May 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 25, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 18, 2013

Completed
Last Updated

April 18, 2013

Status Verified

April 1, 2013

Enrollment Period

1.9 years

First QC Date

May 25, 2011

Last Update Submit

April 17, 2013

Conditions

Keywords

chess, cognition

Outcome Measures

Primary Outcomes (1)

  • Chess games (win/ lose/ tie)

    two years

Secondary Outcomes (4)

  • time period for decision of chess 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)

    outcome of tests

  • measuring of risk taking behaviour, motivation, mood using standardized questionnaires

    outcome of tests

  • adverse events

    type of adverse events

Study Arms (4)

Methylphenidate

EXPERIMENTAL

Methylphenidate

Drug: Drugs use: methylphenidate

modafinil

EXPERIMENTAL

modafinil

Drug: Drug use: modafinil

caffeine

EXPERIMENTAL

caffeine

Drug: caffeine

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

40 mg tablets

Methylphenidate

40 mg tablets

modafinil

400 mg

caffeine

placebo

placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male
  • years old
  • existence of ELO-number

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychiatry and Psychotherapy

Mainz, 55131, Germany

Location

MeSH Terms

Interventions

Caffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Prof. Dr. med. K. Lieb

Study Record Dates

First Submitted

May 25, 2011

First Posted

April 18, 2013

Study Start

May 1, 2011

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 18, 2013

Record last verified: 2013-04

Locations