To replicate and extend the findings of the recent methylphenidate study in which methylphenidate was found to enhance episodic memory performance; To explore whether this effect of methylphenidate is primarily mediated by its dopaminergic action.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
geen aandoening
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoints are the Contingent Negative Variation (CNV) amplitude in the
electroencephalogram (EEG) and the response time on the Response preparation
(Lines and Stoplight) tasks. For memory functions: total number of words
recalled at immediate recall in word learning test (WLT); number of words
recalled in WLT at delay of 30 min and 24h; accuracy and reaction time
recognition test of WLT, heart rate, prolactine levels in blood.
Secondary outcome
Secondary parameters are performance on a Sternberg memory scanning task,
Object relocation, Set shifting, paired associates learning test; Visual
analogue scales: Profile of moods states (POMS) and Bond & Lader (B&L); Resting
EEG.
Background summary
A recent study at our lab showed increased episodic memory consolidation and
response readiness after treatment with methylphenidate in healthy volunteers.
We seek to replicate and extend these findings. Furthermore the pharmacological
specificity of these effects will be studied. Since methylphenidate blocks the
dopamine transporter as well as the noradrenaline transporter, either dopamine
or noradrenaline could be responsible for the observed effects. In order to
explore the dopamergic contribution to this effect, the study proposed here
includes not only methylphenidate but also levodopa/carbidopa.
Study objective
To replicate and extend the findings of the recent methylphenidate study in
which methylphenidate was found to enhance episodic memory performance; To
explore whether this effect of methylphenidate is primarily mediated by its
dopaminergic action.
Study design
The study will be conducted according to a double-blind, placebo-controlled,
3-way cross-over design
Intervention
Participants will be treated with methylphenidate, levodopa/carbidopa or
placebo. All medications will be administered orally with a capsule. The
treatment order will be established by counterbalancing.
Study burden and risks
The time investment for the participants will be around 15 hours in total,
which is comprised of 1) medical screening (around 1.5 hours), 2) training
session of cognitive tasks (around 1.5 hours), 3) three test sessions of around
3.5 hours, including 2 blood samples per day (5mL each), and 4) three sessions
to do a 24h delayed recall test of words learned the day after each test day
(0.5 h).
The day before each test day, the participants are not allowed to drink any
alcohol.
postbus 616
6200MD Maastricht
NL
postbus 616
6200MD Maastricht
NL
Listed location countries
Age
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.
- having suffered from depression, bipolar disorder, anxiety disorder, panic disorder, psychosis, or attention deficit hyperactivity disorder
- those volunteers who have a 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, and any sensory or motor deficits which could reasonably be expected to affect test performance.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2010-021991-27-NL |
| CCMO | NL33321.068.10 |