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The effects of morning versus evening dose of an antihistamine on cognition.


- candidate number5750
- NTR NumberNTR1816
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mei-2009
- Secondary IDs09-3-025 MEC MUMC
- Public TitleThe effects of morning versus evening dose of an antihistamine on cognition.
- Scientific TitleThe effects of morning versus evening dose of hydroxyzine 50 mg on cognition in healthy volunteers.
- ACRONYMN/A
- hypothesisThe 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.
- Healt Condition(s) or Problem(s) studiedHealthy subjects, Sedation, Antihistamines
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 4-jun-2009
- planned closingdate1-nov-2009
- Target number of participants18
- Interventions1. Hydroxyzine 50 mg;
2. Placebo.
- Primary outcomeThe Mean Absolute Tracking Error (mm) of the Divided Attention Task.
- Secondary outcome1. 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.
- TimepointsThree testperiods of each an evening, a night and the morning after.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. J.G. Ramaekers
- CONTACT for SCIENTIFIC QUERIESDr. J.G. Ramaekers
- Sponsor/Initiator University Maastricht (UM)
- Funding
(Source(s) of Monetary or Material Support)
University Maastricht (UM)
- PublicationsN/A
- Brief summaryThe 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.
- Main changes (audit trail)
- RECORD14-mei-2009 - 30-sep-2009


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