Dopaminergic Modulation of Cognition and Psychomotor Function

Sponsor

Maastricht University Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01218425

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Nov 1, 2010

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

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 Names: Ritalin RVG 03957 Drug: Levodopa/carbidopa 125 mg oral dose, 100 mg levodopa, 25 mg carbidopa in one capsule Other Names: Sinemet RVG08740 Drug: Domperidon 10 mg Domperidon 10 mg Other Names: Domperidon RVG 23565

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 Names:

Ritalin RVG 03957

Drug: Levodopa/carbidopa 125 mg

oral dose, 100 mg levodopa, 25 mg carbidopa in one capsule

Other Names:

Sinemet RVG08740

Drug: Domperidon 10 mg

Domperidon 10 mg

Other Names:

Domperidon RVG 23565

Outcome Measures

Primary Outcome Measures

Behavioral score on the Word learning test [1 day]
Number of words recalled in the word learning test

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

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