Double-blind clinical assessment of alprazolam, a new benzodiazepine derivative, in the treatment of moderate to severe anxiety.

Abstract

This four-week, double-blind, placebo-controlled clinical trial assessed the new benzodiazepine derivative alprazolam (Xanax) treatment of moderate to severe anxiety characteristic of anxiety neurosis. Sixty-two outpatients participated; 8 per cent of those taking drug and 52 per cent of those taking placebo discontinued participation due to side effects or lack of efficacy. The mean total daily alprazolam dose was 1.35 mg taken in divided doses. Alprazolam significantly improved scores on five anxiety rating scales--Hamilton Anxiety Rating Scale, Physician's Global Impressions, Target Symptoms Record, Self-Rating Symptom Scale, and Patient's Global Impressions. Alprazolam patients experienced no clinically significant changes in vital signs and laboratory values; they reported drowsiness as the most frequent side effect. We conclude that alprazolam is an effective and safe anxiolytic agent.