Our primary objective is to investigate the effects of methylphenidate on language comprehension and creativity, and to link these effects with the effects of methylphenidate on working memory. Our secondary objective is to establish the relation…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
language& creativity in healthy controls
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary study parameters will include task performance (e.g. accuracy, reaction
times), electroencephalographic (EEG) measures, measures of baseline
characteristics (e.g. working memory capacity, eye blink rate), subjective
measures (e.g. self-report questionnaires, visual analogue scales) and
physiological measures (e.g. heart rate, blood pressure).
Secondary outcome
not applicable
Background summary
Brain dopamine is known for its impact on prefrontal functions. A growing
number of studies showed the effects of dopamine reuptake inhibitor
methylphenidate on cognitive control, working memory and response inhibition.
The methylphenidate effects on cognitive control and working memory likely have
consequences for other cognitive domains such as language and creativity.
However, there is no empirical evidence for such cross-domain effects. We
therefore aim to fill the gap by investigating the effects of methylphenidate
on language comprehension and creativity. It is also known that the impact of
methylphenidate on prefrontal functions varies across individuals. The effects
of methylphenidate on language comprehension and creativity might also relate
to individual subjects* baseline characteristics such as working memory
capacity, eye blink rate and baseline creativity.
Study objective
Our primary objective is to investigate the effects of methylphenidate on
language comprehension and creativity, and to link these effects with the
effects of methylphenidate on working memory. Our secondary objective is to
establish the relation between the methylphenidate effects and the cognitive
baseline characteristics of individual subjects.
Study design
This study will use a within-subject double-blind placebo-controlled randomized
crossover design. The subjects will receive either 20mg oral methylphenidate or
placebo capsule in each session. Methylphenidate has been approved for clinical
use in the Netherlands and the drug can be administered safely without any
relevant risk of serious adverse events.
Study burden and risks
The subject will have to visit the laboratory site twice. At each visit they
will have to complete a series of language, creativity and working memory tasks
after receiving 20mg methylphenidate or placebo. On the day before each visit
they will have to adhere to some simple restrictions regarding medication,
alcohol and drug intake. In the morning of each visit they will have to refrain
from smoking and stimulant-containing drinks. The most common side effects of
methylphenidate include headache, dizziness, nausea and anxiety. However,
previous studies have shown that the single dose of 20mg (or more)
methylphenidate is well tolerated in healthy adults. Considering the extensive
exclusion criteria, screening procedure and constant monitoring of the
subjects, we do not expect serious side effects.
Kapittelweg 29
Nijmegen 6525EN
NL
Kapittelweg 29
Nijmegen 6525EN
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers between 18 and 45 years old
Exclusion criteria
History of neurological or psychiatric disorders; history of drug abuse; heart problems (see section 4.3 of the research protocol for a full list of exclusion criteria)
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51075.091.14 |
| OMON | NL-OMON28408 |