Befloxatone is a new reversible and selective
monoamine oxidase (
MAO-A) inhibitor that has been shown to have
antidepressant activity in various animal models. To assess the effects of single oral doses of
befloxatone (5, 10, and 20 mg) on psychomotor performance and memory, a randomized, double-blind, five-way, crossover study with both placebo and
amitriptyline (50 mg) was carried out in 15 healthy male volunteers. Psychomotor and cognitive functions were evaluated using both objective measures, including Critical Flicker Frequency (CFF), Choice Reaction Time (CRT), Digit Symbol Substitution Test (DSST), and a picture memory test and subjective measures, including Visual Analog Scales (VAS) and Addiction Research Center Inventory (ARCI), before and 2, 4, and 8 hours after administration. Pupil diameter was recorded by videopupillography. Single doses of
befloxatone from 5 to 20 mg did not result in any detrimental effects on skilled performance and memory. In contrast,
amitriptyline significantly impaired arousal (CFF), speed of reaction (CRT), information processing (DSST) and long-term memory (delayed free recall of pictures) and produced subjective sedation from 2 to 8 hours after administration. At the doses studied
amitriptyline induced
miosis but
befloxatone did not modify pupil diameter. There was no evidence in this study to suggest that
befloxatone, at the doses studied, has any
sedative or amnesic effects in healthy subjects.