A fixed-dose study of adinazolam-SR tablets in generalized anxiety disorder

1. This four-week, randomized, double-blind, multicenter study compared the efficacy and safety of adinazolam-SR, at three dosage levels, with placebo. Forty (40) patients were randomized at our site: 10 to adinazolam 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 > or = 21 at baseline. 2. The data were analyzed by pooling the three adinazolam groups and comparing them with the placebo group using t-tests. HAM-A scores decreased significantly more in the pooled adinazolam-SR treatment group than in the placebo 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" (> or = 50% reduction on the baseline HAM-A score) while none of the placebo patients were responders (p < .05). Dose-response effects were evaluated and relationships were not statistically significant. 4. The results indicate that adinazolam-SR was clearly superior to placebo for the treatment of patients suffering from Generalized Anxiety Disorder.