Dopamine Activity Clinical Trial
Official title:
Dopaminergic Modulation of Cognition and Psychomotor Function
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
| Status | Completed |
| Enrollment | 20 |
| Est. completion date | June 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 45 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| Netherlands | Maastricht University | Maastricht | Limburg |
| Lead Sponsor | Collaborator |
|---|---|
| Maastricht University Medical Center |
Netherlands,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Behavioral score on the Word learning test | Number of words recalled in the word learning test | 1 day | No |
| Secondary | CNV amplitude | Amplitude of the CNV wave in the EEG | 1 day | No |
| Secondary | Reaction time on the CNV | Reaction time in the response preparation task in which CNV is measured | 1 day | No |