To determine the specificity of the effects of histamine H1-receptor blockade on different cognitive functions and processes.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde vrijwilligers
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reaction time in milliseconds as measured by the choice reaction time task,
n-back memory task and word recognition task. The number of memorized words
during the immediate recall phase and during the delayed recall (few minutes)
phase (45 minutes). Number of correct detected letters in the n-back task.
Average deviation from midline as measured by the sub-critical tracking task.
The different ERP components: N100/P100, N200/P200, P300, CNV and LRP.
Secondary outcome
not applicable
Background summary
Mental and other neurological disorders like, for example, Alzheimer's disease,
but also allergies are being treated with medication which have a very
non-specific action. This is a cause of an excessive amount of side effects. By
investigating which cognitive functions and processes are specifically
disrupted when the underlying transmitter system is manipulated knowledge is
obtained which can be used to develop medication in a more goal directed
fashion.
Recently it has been shown that histamine H1-recptor blockade leads to impaired
psychomotor and attentional functioning, but not to impaired memory functioning
in humans. In contrast in animals it has been shown that the histaminergic
system is involved in memory functioning. By measuring both memory and
psychomotor functioning after the administration of an antihistamine and to
compare the performance to that after the intake of lorazepam (which is known
to produce memory and psychomotor impairments), knowledge is obtained regarding
the specificity of the effects of the antihistamine. This will benefit the
development of new drug treatments.
Study objective
To determine the specificity of the effects of histamine H1-receptor blockade
on different cognitive functions and processes.
Study design
The study is conducted according to 3-way, dubble blind, randomized,
placebo-controlled, cross-over design
Intervention
On each testday volunteers recieve either of the following treatments:
dexchlorpheniramine 4 mg, lorazepam 1 mg or placebo.
Study burden and risks
Subjects will receive a medical check which will take no longer than one hour.
The complete procedure will be done by a qualified physician or other trained
person. The training of the performance on the tasks will take 4 hours spread
over two days. Each of the test days last for 4.5 hours in which subjects
perform the previous trained tasks. On two of these days subjects receive an
active substance (dexchlorpheniramine en lorazepam) which can cause temporary
side effects.
this research will produce information regarding the specificity of the
H1-receptor blockade and will thereby aid to the goal directed development of
more specific drug treatments.
Postbus 616
6200 MD Maastricht
Nederland
Postbus 616
6200 MD Maastricht
Nederland
Listed location countries
Age
Inclusion criteria
Males and females
Age 18-45
Good physical health as determined by a medical history questionnaire, medical screening by a physician, ECG and blood haematology
Absence of any medical, endocrine and neurological condition
Body mass index (weight/length2) between 18 and 28 kg/m2
Blood pressure between 100-150 Hg systolic and 60-90 Hg diastolic
Written informed consent
Exclusion criteria
History of or current drug abuse
Current use of psychoactive medicinal treatment
Drinking more than 20 alcoholic consumptions per week
For females: pregnancy or lactation
Drinking more than 5 cups of caffeinated drinks per day
Smoking more than 5 cigarettes per day
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 | EUCTR2006-004324-37-NL |
| CCMO | NL13972.068.06 |