Randomised, duoble-blind, placebo-controlled, 3-way crossover study to investigate the effect of 10 mg Lu AA21004 and 30 mg mirtazapine on actual driving performance, psychomotor function and cognitive function in healthy subjects
Completed
- Conditions
- n.v.t. onderzoek betreft gezonde vrijwilligersdepressionanxiety disorders
- Registration Number
- NL-OMON33491
- Lead Sponsor
- undbeck
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 21
Inclusion Criteria
healthy
age between 21 and 45 years
BMI between 19 and 29 kg/m2
possession of a valid driving licence for at least 3 years
driving experience at least 5000 km per year on average
Exclusion Criteria
use of other medication (except anticonception or paracetamol)
pregnancy
smoking
use of drugs
excessive use of alcohol and caffein
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>to compare the effects of 10 mg Lu AA21004 and placebo on actual driving<br /><br>performance in healthy subjects, following the first dose and at steady-state,<br /><br>as measured by standard deviation of lateral position (SDLP) during an<br /><br>on-the-road driving test</p><br>
- Secondary Outcome Measures
Name Time Method <p>*to compare the effects of 30 mg mirtazapine and placebo on actual driving<br /><br>performance in healthy subjects, following the first dose and at steady-state,<br /><br>as measured by SDLP during an on-the-road driving test<br /><br>*to compare the effects of 10 mg Lu AA21004 and 30 mg mirtazapine on actual<br /><br>driving performance in healthy subjects, following the first dose and at<br /><br>steady-state, as measured by SDLP during an on-the-road driving test<br /><br>*to assess the effects of 10 mg Lu AA21004 and 30 mg mirtazapine on standard<br /><br>deviation of speed (SDS) measured during an on-the-road driving test following<br /><br>the first dose and at steady-state<br /><br>*to assess on a explorative basis the effects of 10 mg Lu AA21004 and 30 mg<br /><br>mirtazapine on psychomotor and cognitive functions, following the first dose<br /><br>and at steady-state</p><br>