Mexazolam and Alprazolam in the Treatment of Generalised Anxiety Disorder

Abstract

To compare the anxiolytic effects of mexazolam with those of alprazolam in patients with generalised anxiety disorder (GAD). Multicentre, randomised, double-blind, parallel-group clinical trial in 64 outpatients with GAD (DSM-IV criteria). Patients were assigned to mexazolam 1mg three times daily (n = 32) or alprazolam 0.5mg three times daily (n = 32) during 1 week, followed sequentially by a period of 2 weeks of reducing dosage according to therapeutic response and by 1-week taper and 1-week treatment-free periods. The Hamilton Anxiety Rating Scale (HAM-A), the Clinical Global Impression (CGI), and the Snaith & Zigmund anxiety and depression self-rating scale (SZS) were used to evaluate the patient’s clinical status. Both treatment groups showed a statistically significant anxiolytic effect: a decrease of mean HAM-A score of 16.28 with mexazolam (p < 0.0001 vs baseline) and 14.2 with alprazolam (p < 0.0001) and a reduction in CGI-disease severity score of 2.66 (p < 0.0001) with mexazolam and 2.44 with alprazolam (p < 0.0001). Although a higher absolute rate of responders was observed in the mexazolam group, there were no statistically significant differences in the between-group comparisons (80% vs 70% in HAM-A and 96.7% vs 86.7% in CGI evaluations). Five mexazolam and nine alprazolam recipients reported mild adverse events. Both mexazolam and alprazolam showed a significant anxiolytic effect and were well tolerated in the treatment of GAD, making it an effective pharmacotherapeutic alternative in the treatment of GAD.