No registrations found.
ID
Source
Brief title
Health condition
Sedation / sedatie
Antihistamines / antihistaminica
Sponsors and support
Intervention
Outcome measures
Primary outcome
The Mean Absolute Tracking Error (mm) of the Divided Attention Task.
Secondary outcome
1. Sensori-motor test: Critical Tracking task;
2. Attention task: Attentional Network Test;
3. Impulsivity tests: Stop Signal Task, Attentional Switch test;
4. Event related potentials: P1, P3, N1, N2.
Background summary
The mechanism responsible for the reversion of sedative effects caused by antihistamines might be mediated by restoring the balance between histamine release and synthesis after sleep. This would mean that histamine availability will be greatest shrotly after awakening. Because of that, the antihistamine will have less binding potential during that time compared to other times of administration. This study focuses therefore on the time-depending effects of the antihistamine hydroxyzine on cognition.
Study objective
The behavioural effects of an antihistamine is apparent in the evening after an evening dose, but will be smaller in the morning after a morning dose condition due to the excessive release of histamine shortly after awaking.
Study design
Three testperiods of each an evening, a night and the morning after.
Intervention
1. Hydroxyzine 50 mg;
2. Placebo.
Dept of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience,
P.O. Box 616
J.G. Ramaekers
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881951
J.Ramaekers@psychology.unimaas.nl
Dept of Neuropsychology & Psychopharmacology, Faculty of Psychology and Neuroscience,
P.O. Box 616
J.G. Ramaekers
Maastricht 6200 MD
The Netherlands
+31 (0)43 3881951
J.Ramaekers@psychology.unimaas.nl
Inclusion criteria
1. Aged between 18 and 45 years;
2. Healthy volunteers;
3. BMI between 19 and 30;
4. Able to give a written informed consent;
5. Able to understand the protocol and to come to the visits;
6. Use of a contraceptive method (for women).
Exclusion criteria
1. Medical history of major medical, psychiatric illness or surgery which, in the judgement of the investigator, could jeopardize their health or is likely to modify their handling of the study drug;
2. Any non corrected visual defect or locomotor disorder which could interfere with the study;
3. Acute or chronic systemic disease or disorder;
4. History of hypersensitivity to H1 antihistamines, benzimidazoles or lactose;
5. Seasonal allergic rhinitis or urticaria treated by antihistamine;
6. History of alcohol or drug abuse.
Design
Recruitment
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 |
|---|---|
| NTR-new | NL1706 |
| NTR-old | NTR1816 |
| Other | MEC MUMC : 09-3-025 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |