PHARMACOELECTROENCEPHALOGRAPHIC PROFILE OF BEFLOXATONE, A NEW REVERSIBLE MAO-A INHIBITOR, IN HEALTHY-SUBJECTS

The pharmaco-EEG profile and the effects on P300 and CNV of befloxaton e, a new selective and reversible MAO-A inhibitor, were assessed in a randomized, double-blind, placebo-controlled, 4-way crossover study. T welve healthy young male volunteers were administered single doses of 2.5, 10 and 20 mg befloxatone and placebo separated by a 1-week washou t. The EEG data were recorded before and at least 6 h after drug admin istration, by means of 28 leads allowing topographical analysis of the results. MAO inhibition, subjective effects and safety variables were also investigated. Statistical analysis was performed by means of the SDT method. Befloxatone induced dose-related EEG changes which occurr ed rapidly, peaked between 0.5 and 2 h and lasted at least until 6 h a fter drug administration. The EEG changes were characterized by an inc rease in absolute and/or relative alpha power, mainly alpha 1, after t he 3 doses and a theta power increase after 10 and 20 mg only. These c hanges occurred mainly over the centroparietotemporal areas. Concernin g the event-related potential, P300 latency of the auditory evoked pot entials did not change. The P300 and CNV mean topographic amplitudes w ere decreased, between 0.5 and 2 h, after the two lowest doses for the P300 and the 3 doses for the CNV. After administration of 2.5, 10 and 20 mg, MAO inhibition was shown by respectively 38, 76 and 81% reduct ion in plasma free 3, MAO inhibitors 4-dihydroxyphenylglycol reached a fter 2-4 h. Such a pharmaco-EEG profile, occurring at doses inducing M AO-A inhibition, is similar to those already described with nonsedativ e antidepressants.