A FIXED-DOSE STUDY OF ADINAZOLAM-SR TABLETS IN GENERALIZED ANXIETY DISORDER

1. This four-week, randomized, double-blind, multicenter study compare d the efficacy and safety of adinazolam-SR at three dosage levels, wit h placebo. Forty (40) patients were randomized at our site: 10 to adin azolam 30 mg/day, 10 to 60 mg/day, 10 to 90 mg/day, and 10 to placebo. All patients were moderately anxious with Hamilton Anxiety Scale (HAM -A) scores of greater than or equal to 21 at baseline. 2. The data wer e analyzed by pooling the three adinazolam groups and comparing them w ith the placebo group using t-tests. HAM-A scores decreased significan tly more in the pooled adinazolam-SR treatment group than in the place bo group at both Week one (p < .02) and at Week two (p < .01), as well as at endpoint (p < .03). 3. At endpoint the adinazolam-treated group included 8 ''responders'' (greater than or equal to 50% reduction on the baseline HAM-A score) while none of the placebo patients were resp onders (p < .05). Dose-response effects were evaluated and relationshi ps were not statistically significant. 4. The results indicate that ad inazolam-SR was clearly superior to placebo for the treatment of patie nts suffering from Generalized Anxiety Disorder.