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Dopaminergic Modulation of Cognition and Psychomotor Function

NCT ID: NCT01218425

Last Updated: 2012-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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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

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Conditions

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Dopamine Activity Episodic Memory Consolidation Response Preparation

Keywords

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dopamine EEG episodic memory contingent negative variation response preparation levodopa methylphenidate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Medication

In this study, a crossover design is applied. All participants receive all three treatments in randomized order on separate days.

Group Type EXPERIMENTAL

Methylphenidate 40 mg

Intervention Type DRUG

Oral dose 40 mg

Levodopa/carbidopa 125 mg

Intervention Type DRUG

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

Domperidon 10 mg

Intervention Type DRUG

Domperidon 10 mg

Interventions

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Methylphenidate 40 mg

Oral dose 40 mg

Intervention Type DRUG

Levodopa/carbidopa 125 mg

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

Intervention Type DRUG

Domperidon 10 mg

Domperidon 10 mg

Intervention Type DRUG

Other Intervention Names

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Ritalin RVG 03957 Sinemet RVG08740 Domperidon RVG 23565

Eligibility Criteria

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Inclusion Criteria

* Male or female
* 18 to 45 years of age

Exclusion Criteria

* Body mass index between 18.5 and 30
* Willingness to sign an informed consent.


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Maastricht University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Vuurman, Dr.

Role: PRINCIPAL_INVESTIGATOR

Dept Neuropsychology and Psychopharmacology, Maastricht University

Locations

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Maastricht University

Maastricht, Limburg, Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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10-3-056

Identifier Type: -

Identifier Source: org_study_id