Cognitively Healthy Subjects Influenced by Psychoactive DrugsPhase 1CHESSNCT01834547
Cognitive Hyper-performance - Effects of Stimulating Substances in Chess-players
A Phase 1 study testing Drugs use: methylphenidate, Drug use: modafinil and caffeine in people with Cognitively Healthy Subjects Influenced by Psychoactive Drugs, run by K. Lieb at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cognitively Healthy Subjects Influenced by Psychoactive Drugs
- What is being tested?
- Drugs use: methylphenidate, Drug use: modafinil and caffeine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteGermany
- Study dates
- May 2011to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- male
- 18-60 years old
- existence of ELO-number
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- Drugs use: methylphenidate, Drug use: modafinil, caffeine, placebo
- Keywords
- chess, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drugs use: methylphenidateDrug
40 mg tablets
Drug use: modafinilDrug
40 mg tablets
caffeineDrug
400 mg
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | Methylphenidate Receives: Drug: Drugs use: methylphenidate |
| modafinil | Experimental | modafinil Receives: Drug: Drug use: modafinil |
| caffeine | Experimental | caffeine Receives: Drug: caffeine |
| placebo | Placebo comparator | placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chess games (win/ lose/ tie)
Measured: two years
Secondary outcomes (4)
time period for decision of chess games
Measured: 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)
Measured: outcome of tests
measuring of risk taking behaviour, motivation, mood using standardized questionnaires
Measured: outcome of tests
adverse events
Measured: type of adverse events
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startMay 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitively Healthy Subjects Influenced by Psychoactive DrugsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- K. Lieb
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, K. Lieb, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834547
- Sponsor's protocol ID
- 1234
- Acronym
- CHESS
- Status last verified
- Apr 2013
- First submitted
- 25 May 2011
- Last updated
- 18 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study About Effects of Caffeine, Methylphenidate, Modafinil and Placebo on Cognitive Performance of Chess Players.
- ClinicalTrials.gov ID
- NCT01834547
- Acronym / sponsor ID
- CHESS / 1234
- Keywords
- chess, cognition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- K. LiebUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: Drugs use: methylphenidateMethylphenidate |
| modafinil | Experimental | Drug: Drug use: modafinilmodafinil |
| caffeine | Experimental | Drug: caffeinecaffeine |
| placebo | Placebo comparator | Drug: placeboplacebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- male
- 18-60 years old
- existence of ELO-number
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drugs use: methylphenidate40 mg tablets | Drug | Methylphenidate |
| Drug use: modafinil40 mg tablets | Drug | modafinil |
| caffeine400 mg | Drug | caffeine |
| placeboplacebo | Drug | placebo |
Primary outcome
Chess games (win/ lose/ tie)
Time frame: two years
4 secondary outcomes
time period for decision of chess games
Time frame: 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
measuring of risk taking behaviour, motivation, mood using standardized questionnaires
Time frame: outcome of tests
adverse events
Time frame: type of adverse events
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Drugs use: methylphenidate, Drug use: modafinil and caffeine in people with Cognitively Healthy Subjects Influenced by Psychoactive Drugs, run by K. Lieb at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chess games (win/ lose/ tie) (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2013.