Dopaminergic Modulation of Cognition and Psychomotor Function

Not Applicable

Completed

• Conditions: Dopamine Activity; Episodic Memory Consolidation; Response Preparation
• Interventions: Drug: Methylphenidate 40 mg; Drug: Levodopa/carbidopa 125 mg; Drug: Domperidon 10 mg

• Registration Number: NCT01218425
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-09-22
• Study First Submitted QC: 2010-10-07
• Study First Posted: 2010-10-11
• Study Start: 2010-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-24
• Last Update Posted: 2012-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Medication	Methylphenidate 40 mg	In this study, a crossover design is applied. All participants receive all three treatments in randomized order on separate days.
Medication	Levodopa/carbidopa 125 mg	In this study, a crossover design is applied. All participants receive all three treatments in randomized order on separate days.
Medication	Domperidon 10 mg	In this study, a crossover design is applied. All participants receive all three treatments in randomized order on separate days.

Primary Outcome Measures

Name	Time	Method
Behavioral score on the Word learning test	1 day	Number of words recalled in the word learning test

Secondary Outcome Measures

Name	Time	Method
CNV amplitude	1 day	Amplitude of the CNV wave in the EEG
Reaction time on the CNV	1 day	Reaction time in the response preparation task in which CNV is measured

Trial Locations

Locations (1)

Maastricht University; 🇳🇱 Maastricht, Limburg, Netherlands