Double-blind efficacy and safety study comparing adinazolam mesylate and placebo in depressed inpatients.

In a 6-week, randomized, double-blind study, adinazolam mezylate (Deracyn Tablets, The Upjohn Company) was compared with placebo for the treatment of depression in 80 inpatients who met the criteria for single episode or recurrent DSM-III Major Depression. Subjects were admitted to the hospital 3 days before the start of the study and remained hospitalized for at least the first week of treatment. Efficacy was evaluated after 2, 4, 7, 14, 28, and 42 days of treatment. Adinazolam was significantly superior to placebo on all observer-rated and all global patient-rated measures of efficacy. Twenty-five subjects (63%) completed 6 weeks of adinazolam treatment and of these, 88% responded within 7 days. Only 15 placebo-treated subjects (38%) completed the study. Drowsiness and mild to moderate cognitive complaints were the only side effects observed more frequently with adinazolam, and both were transient. The results show that adinazolam is safe and more effective than placebo for the treatment of major depression.

RCT Entities:   Population Interventions Outcomes