The current study aims to further our understanding of the relationship between baseline measures - such as impulsivity, working memory and social support - and the effects of enhancing dopamine (via methylphenidate administration) across a wide…
ID
Source
Brief title
Condition
- Cognitive and attention disorders and disturbances
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The current study will collect the following primary study parameters
Baseline measures:
Barratt Simplified Measure of Social Status (Average score)
Multidimensional Scale of Perceived Social Support (Average score)
Dominance scale (Average score)
The Beck Depression Inventory (Average score)
The Barratt Impulsiveness Scale (Average score)
The BIS/BAS (Behavioural Inhibition Scale/Behavioural Activation (BIS/BAS)
Scale (Average score)
The Daneman and Carpenter listening span test (Average score)
Outcome measures:
Social Learning (Beta value for personal learning)
Social Learning (Win-stay, lose-shift behaviour)
Social Learning (Perseveration)
Working memory (Accuracy and reaction time)
Motivation x activation reinforcement learning task (Pavlovian bias)
Probabilistic reversal learning (Lose-switch, win-stay behaviour)
Probabilistic reversal learning (Perseveration)
Pavlovian to Instrumental Transfer (Vigour changes upon Pavlovian stimuli)
Demand selection task task (Bias towards easy/difficult condition)
Secondary outcome
Secondary measures will also be collected for each task (see section 6.1.2 of
the research protocol (C1) for further details)
Background summary
It is known that adequate dopaminergic stimulation is important for many
psychological functions including, memory, learning and social cognition. It is
also known that dopamine levels can be increased by a number of pharmaceutical
agents such as methylphenidate, and that such agents are associated with
significant individual differences. At present our ability to predict
individual differences in the effect of enhancing dopamine across a wide-range
of tasks is limited.
Study objective
The current study aims to further our understanding of the relationship between
baseline measures - such as impulsivity, working memory and social support -
and the effects of enhancing dopamine (via methylphenidate administration)
across a wide range of tasks. The results of this study will help make progress
towards the development of a model which enables the effects of enhancing
dopamine on various domains of cognition to be predicted from an individual's
scores on a selection of baseline measures.
Study design
A within-subject, double-blind, placebo-controlled, design will be employed.
All subjects will visit the Donders Centre for Cognitive Neuroimaging (DCCN)
for two testing sessions that will last between 5 and 6 hours. On study day
one, 50 subjects will receive oral capsules of 20mg methylphenidate and 50
subjects will receive oral placebo capsules. On study day two subjects will
receive the capsule (methylphenidate or placebo) that they did not receive on
study day one. Methylphenidate can be administered safely without any relevant
risk of serious adverse events and has been approved for clinical use in the
Netherlands.
Subjects will be recruited via posters and from the Donders database of
subjects who have expressed an interest in participating in research
(sona-systems). The investigator will send an information brochure to subjects
that respond to these adverts. Approximately one week after receiving the
information brochure a member of the research team will contact the potential
subject by phone or email to answer any questions they have and schedule an
appointment. When subjects arrive at the Donders Centre on the day of testing
they will be asked, by a member of the research time, for their written fully
informed consent before taking part in any study related activities.
On study day one participants will first undergo a medical screening interview
to ensure that they do not meet any of the exclusion criteria. Subjects will
then complete a baseline measure of working memory, receive one oral capsule of
either 20mg MPH or placebo, rest for approximately 1.5 hours, and then complete
the battery of cognitive tests. On study day two, subjects will complete the
same procedure, but without the medical screening interview; in this session
subjects will receive the capsule (methylphenidate or placebo) that they did
not receive on study day one.
Between study days subjects will have copies of a number of questionnaires
emailed or posted to them. Questionnaires will take approximately 1 hour to
complete.
Study burden and risks
Subjects will be asked to complete a battery of computerized tests after
administration of methylphenidate or placebo. On the day preceding the drug
session, subjects will have to adhere to some simple restrictions with respect
to medication, alcohol and drug intake. Also, on the morning of each session,
subjects will have to refrain from smoking and stimulant containing drinks. The
most common side effect of taking methylphenidate is a headache (occurring in
over 10% of people who take the drug). Other, less common, side effects include
feeling dizzy, nauseous or anxious. However, our prior experience with
administering methylphenidate has found that the drug is well tolerated by
subjects. Considering the extensive exclusion criteria, the screening
procedure, and constant monitoring of the subjects we do not expect (S)AE side
effects. The consent discussion starts sufficiently in advance of the
initiation of study-related procedures to allow potential subjects time to
reflect on the potential benefits and risks and possible discomforts. Overall
we believe that the risk associated with participation in this study can be
regarded as minimal.
Kapittelweg 29
Nijmegen 6525 EN
NL
Kapittelweg 29
Nijmegen 6525 EN
NL
Listed location countries
Age
Inclusion criteria
Healthy volunteers between 18 and 45 years of age
Exclusion criteria
Neuropsychiatric disorders; history of drug abuse; heart problems (see section 3.3 in research protocol (C1) for 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 | NL47166.091.13 |
| NTR-new | NL4411 |
| NTR-old | NTR4653 |
| OMON | NL-OMON26989 |