RESUMO
OBJECTIVE: The primary aim of this study was to evaluate the psychomotor effects of mexazolam versus placebo in patients with generalised anxiety disorder (GAD). PATIENTS AND METHODS: This was a multicentre, randomised, double-blind, parallel-group clinical trial in 60 outpatients with GAD (Diagnostic and Statistical Manual of Mental Disorders-4(th) edition [DSM-IV] criteria). After a placebo run-in period, patients were assigned to mexazolam 1mg three times daily (n = 32) or placebo (n = 28) for 21 days. Effects on psychomotor performance were evaluated with the Leeds Psychomotor Test Battery (critical flicker fusion threshold, recognition, motor and total reaction time). The Hamilton Anxiety Rating Scale (HAM-A) and the Clinical Global Impression (CGI) were used to evaluate the patients' clinical status (secondary objective). RESULTS: At neither assessment were any statistically significant differences detected between mexazolam and placebo for CGI, critical flicker fusion, and the different reaction times. The HAM-A total and the HAM-A somatic scores indicated a statistically significant therapeutic effect for mexazolam vs placebo after 1 week of treatment but not after 3 weeks. The most prominent adverse event with mexazolam was mild drowsiness. CONCLUSIONS: Mexazolam in a therapeutically effective dosage regimen does not impair psychomotor performance to a clinically relevant extent.
