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

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 - Lu AA21004 and driving performance

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33491

Enrollment

Registered

2009-03-23

Start date

2009-06-15

Completion date

Unknown

Last updated

2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

n.v.t. onderzoek betreft gezonde vrijwilligers depression

Interventions

The studied treatments consist of multiple dosing (1 dosing per day for 15 consecutive days) of 10 mg Lu AA21004, 30 mg mirtazapine and placebo. Administration of the medication is double-blind. Bet

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: use of other medication (except anticonception or paracetamol) pregnancy smoking use of drugs excessive use of alcohol and caffein

Design outcomes

Primary

Measure	Time frame
to compare the effects of 10 mg Lu AA21004 and placebo on actual driving performance in healthy subjects, following the first dose and at steady-state, as measured by standard deviation of lateral position (SDLP) during an on-the-road driving test	—

Secondary

Measure	Time frame
to compare the effects of 30 mg mirtazapine and placebo on actual driving performance in healthy subjects, following the first dose and at steady-state, as measured by SDLP during an on-the-road driving test to compare the effects of 10 mg Lu AA21004 and 30 mg mirtazapine on actual driving performance in healthy subjects, following the first dose and at steady-state, as measured by SDLP during an on-the-road driving test to assess the effects of 10 mg Lu AA21004 and 30 mg mirtazapine on standard deviation of speed (SDS) measured during an on-the-road driving test following the first dose and at steady-state to assess on a explorative basis the effects of 10 mg Lu AA21004 and 30 mg mirtazapine on psychomotor and cognitive functions, following the first dose and at steady-state	—

Measure

Time frame

*to compare the effects of 30 mg mirtazapine and placebo on actual driving performance in healthy subjects, following the first dose and at steady-state, as measured by SDLP during an on-the-road driving test *to compare the effects of 10 mg Lu AA21004 and 30 mg mirtazapine on actual driving performance in healthy subjects, following the first dose and at steady-state, as measured by SDLP during an on-the-road driving test *to assess the effects of 10 mg Lu AA21004 and 30 mg mirtazapine on standard deviation of speed (SDS) measured during an on-the-road driving test following the first dose and at steady-state *to assess on a explorative basis the effects of 10 mg Lu AA21004 and 30 mg mirtazapine on psychomotor and cognitive functions, following the first dose and at steady-state

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)