Maastricht University
Maastricht, Limburg, 6200, Netherlands
Completed
NCT Number: NCT01218425
Dopaminergic Modulation of Cognition and Psychomotor Function
A recent study at our lab showed increased episodic memory consolidation and response readiness after treatment with methylphenidate in healthy volunteers. The investigators seek to replicate and extend these findings. Furthermore the pharmacological specificity of these effects will be studied. Since methylphenidate has an effect on two neurotransmitters, dopamine and noradrenaline, either could be responsible for the observed effects. In order to explore the dopaminergic contribution to this effect, the study proposed here includes not only methylphenidate but also levodopa/carbidopa, which only affects dopamine and not noradrenaline.
In this study, 20 healthy males and females between 18 and 45 years of age will participate. They will be recruited via advertisements at Maastricht University and in local newspapers.
Participants will be treated once with methylphenidate, once with levodopa/carbidopa and once with placebo. All medications will be administered orally with a capsule.
It is hypothesized that methylphenidate and levodopa/carbidopa will both enhance episodic memory consolidation and improve response readiness
Completed
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Notify MeKey information
Age range
18 year–45 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or female
- 18 to 45 years of age
- Healthy (i.e. absence of all exclusion criteria), normal static binocular acuity (corrected or uncorrected),
- Body mass index between 18.5 and 30
- Willingness to sign an informed consent.
Exclusion criteria
- history of cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal, haematological or psychiatric illness.
- history of depression, bipolar disorder, anxiety disorder, panic disorder, psychosis, or attention deficit hyperactivity disorder will be excluded from participation.
- first-degree relative with a psychiatric disorder or a history with a psychiatric disorder
- excessive drinking (>20 glasses of alcohol containing beverages a week
- pregnancy or lactation
- use of medication other than oral contraceptives
- use of recreational drugs from 2 weeks before until the end of the experiment
- any condition in which gastrointestinal motility might carry any risk
- any sensory or motor deficits which could reasonably be expected to affect test performance
Treatment and study plan
Methylphenidate 40 mg
DrugOral dose 40 mg
Other names: Ritalin RVG 03957
Levodopa/carbidopa 125 mg
Drugoral dose, 100 mg levodopa, 25 mg carbidopa in one capsule
Other names: Sinemet RVG08740
Domperidon 10 mg
DrugDomperidon 10 mg
Other names: Domperidon RVG 23565
Primary outcomes
-
Behavioral score on the Word learning test
Time frame: 1 day
Number of words recalled in the word learning test
Secondary outcomes
-
CNV amplitude
Time frame: 1 day
Amplitude of the CNV wave in the EEG
-
Reaction time on the CNV
Time frame: 1 day
Reaction time in the response preparation task in which CNV is measured
Sponsors and collaborators
Lead sponsor
Maastricht University Medical Center
Other
Registry information
Important dates
- Study start
- 2010
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Oct 11, 2010
- Registry last updated
- Oct 25, 2012
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.