A randomized trial on the acute and steady-state effects of a new antidepressant, vortioxetine (Lu AA21004), on actual driving and cognition

The aim of this study was to assess the effects of a novel antidepressant, vortioxetine 10 mg, on driving, cognitive, and psychomotor performance in 24 healthy subjects in a double-blind, placebo-controlled, three-way crossover design. Mirtazapine 30 mg was included as an active comparator. Drugs we...

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Published inClinical pharmacology and therapeutics Vol. 93; no. 6; p. 493
Main Authors Theunissen, E L, Street, D, Højer, A-M, Vermeeren, A, van Oers, A, Ramaekers, J G
Format Journal Article
LanguageEnglish
Published United States 01.06.2013
Subjects
Adult
Antidepressive Agents - adverse effects
Antidepressive Agents - pharmacokinetics
Antidepressive Agents - pharmacology
Automobile Driving
Cognition - drug effects
Cross-Over Studies
Double-Blind Method
Female
Humans
Male
Mianserin - adverse effects
Mianserin - analogs & derivatives
Mianserin - pharmacokinetics
Mianserin - pharmacology
Piperazines - adverse effects
Piperazines - pharmacokinetics
Piperazines - pharmacology
Psychomotor Performance - drug effects
Sulfides - adverse effects
Sulfides - pharmacokinetics
Sulfides - pharmacology
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Summary:The aim of this study was to assess the effects of a novel antidepressant, vortioxetine 10 mg, on driving, cognitive, and psychomotor performance in 24 healthy subjects in a double-blind, placebo-controlled, three-way crossover design. Mirtazapine 30 mg was included as an active comparator. Drugs were administered in the evening of 15 consecutive days. Performance was measured in the morning of days 2 and 16, using standardized tests measuring on-the-road driving, memory, tracking, divided attention, and vigilance. The statistical analysis on the primary measure of driving, i.e., SD of lateral position showed noninferiority of vortioxetine on days 2 and 16, and inferiority for mirtazapine on day 2. Vortioxetine did not cause cognitive or psychomotor impairment. Mirtazapine, however, impaired cognitive and psychomotor performance on day 2. Most of these effects disappeared after multiple doses of mirtazapine. To conclude, vortioxetine did not impair driving, cognitive, or psychomotor performance after single or multiple doses.
ISSN:1532-6535
DOI:10.1038/clpt.2013.39