Effects of morning versus evening dose of hydroxyzine 50 mg on cognition in healthy subjects

Conditions: To assess the morning versus evening dose effect of hydroxyzine 50 mg on cognition in healthy volunteers

Registration Number: EUCTR2009-012340-16-NL

Lead Sponsor: Maastricht University

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 18

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures