To assess the morning versus evening dose effect of hydroxyzine 50 mg on cognition in healthy volunteers
Conditions
Interventions
Trade Name: ATARAX
Product Name: ATARAX
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Maastricht University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - aged between 21 and 45 years - healthy volunteers - BMI (Body Mass Index) between 19 and 30 included - able to give a written informed consent - suvject who, in the judgement of the investigator is likely to be compliant during the study - able to understand the protocol and to come to the visits Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - History of drug or alcohol abuse - History of hypersensitivity to H1 antihistamines, benzimidazoles or lactose - Seasonal allergic rhinitis or urticaria treated by antihistamines - Smoking more thab 2 cigarettes a day - Drinking more than 6 cups of coffee per day - Drinking more than 21 glasses of alcohol per week
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the effect of the H1-antagonist hydroxyzine 50 mg morning versus evening dose on behavioural and electrocortical indicators on motor response, attention and impulsivity, using a test battery, task manipulations and measurement of event related potentials;Secondary Objective: ;Primary end point(s): The Mean Absolute Tracking Error (mm) if the Divided Attention Task | — |
Countries
Netherlands
Outcome results
None listed