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Dopaminergic Modulation of Cognition and Psychomotor Function

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01218425
First received: September 22, 2010
Last updated: October 24, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Dopamine Activity
Episodic Memory Consolidation
Response Preparation
 Drug: Methylphenidate 40 mg
Drug: Levodopa/carbidopa 125 mg
Drug: Domperidon 10 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Dopaminergic Modulation of Cognition and Psychomotor Function

Resource links provided by NLM:

MedlinePlus related topics: Memory
U.S. FDA Resources

Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Behavioral score on the Word learning test [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Number of words recalled in the word learning test


Secondary Outcome Measures:
  • CNV amplitude [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Amplitude of the CNV wave in the EEG

  • Reaction time on the CNV [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Reaction time in the response preparation task in which CNV is measured


Enrollment: 20
Study Start Date: November 2010
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01218425

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

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01218425     History of Changes
Other Study ID Numbers: 10-3-056
Study First Received: September 22, 2010
Last Updated: October 24, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
dopamine
EEG
episodic memory
contingent negative variation
 response preparation
levodopa
methylphenidate

Additional relevant MeSH terms:
Carbidopa
Levodopa
Domperidone
Dopamine
Dopamine Agents
Methylphenidate
Dopamine Agonists
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
 Neurotransmitter Agents
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents
Dopamine Antagonists
Cardiotonic Agents
Cardiovascular Agents
Sympathomimetics
Protective Agents
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Central Nervous System Stimulants

ClinicalTrials.gov processed this record on May 16, 2013