Dopaminergic Modulation of Cognition and Psychomotor Function

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01218425
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : October 25, 2012
Information provided by (Responsible Party):
Maastricht University Medical Center

Brief Summary:

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

Condition or disease Intervention/treatment Phase
Dopamine Activity Episodic Memory Consolidation Response Preparation Drug: Methylphenidate 40 mg Drug: Levodopa/carbidopa 125 mg Drug: Domperidon 10 mg Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Dopaminergic Modulation of Cognition and Psychomotor Function
Study Start Date : November 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Domperidone

Arm Intervention/treatment
Experimental: Medication
In this study, a crossover design is applied. All participants receive all three treatments in randomized order on separate days.
Drug: Methylphenidate 40 mg
Oral dose 40 mg
Other Name: Ritalin RVG 03957

Drug: Levodopa/carbidopa 125 mg
oral dose, 100 mg levodopa, 25 mg carbidopa in one capsule
Other Name: Sinemet RVG08740

Drug: Domperidon 10 mg
Domperidon 10 mg
Other Name: Domperidon RVG 23565

Primary Outcome Measures :
  1. Behavioral score on the Word learning test [ Time Frame: 1 day ]
    Number of words recalled in the word learning test

Secondary Outcome Measures :
  1. CNV amplitude [ Time Frame: 1 day ]
    Amplitude of the CNV wave in the EEG

  2. Reaction time on the CNV [ Time Frame: 1 day ]
    Reaction time in the response preparation task in which CNV is measured

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01218425

Maastricht University
Maastricht, Limburg, Netherlands, 6200
Sponsors and Collaborators
Maastricht University Medical Center
Principal Investigator: Eric Vuurman, Dr. Dept Neuropsychology and Psychopharmacology, Maastricht University

Responsible Party: Maastricht University Medical Center Identifier: NCT01218425     History of Changes
Other Study ID Numbers: 10-3-056
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: October 25, 2012
Last Verified: October 2012

Keywords provided by Maastricht University Medical Center:
episodic memory
contingent negative variation
response preparation

Additional relevant MeSH terms:
Dopamine Agents
Dopamine Agonists
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Aromatic Amino Acid Decarboxylase Inhibitors
Enzyme Inhibitors
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Cardiotonic Agents
Protective Agents