A Double-Blind, Placebo-Controlled Study Comparing the Efficacy and Safety of Ipsapirone Versus Lorazepam in Patients With Generalized Anxiety Disorder

Abstract

This multicenter, double-blind, placebo-controlled, randomized study compared the efficacy, safety, and tolerability of ipsapirone (an azapirone anxiolytic) at daily dose levels of 10.0 to 30.0 mg with a daily dose of 2.0 to 6.0 mg of lorazepam (a benzodiazepine) or placebo when given to outpatients with generalized anxiety disorder (GAD) of moderate or greater severity. A total of 317 outpatients with a primary diagnosis of GAD according to DSM-III criteria (at least 1 month's duration) were randomized. Study entry criteria at the time of screening and at baseline included a Hamilton Rating Scale for Anxiety (HAM-A) score of 18 or more, a Covi Anxiety Scale score of 8 or more, and a Raskin Depression Scale score of 7 or less. The study design consisted of a 1-week, single-blind placebo evaluation, a 4-week, double-blind acute treatment period, and a 4-week extension period, followed by a 2-week, single-blind placebo withdrawal period. Efficacy was measured by changes in the HAM-A and Clinical Global Impression Scale and by evaluations of the Hamilton Rating Scale for Depression and Zung-Anxiety Self-Rating scale. The Raskin and Covi scales were performed at screening and baseline only. Withdrawal reactions were assessed during the withdrawal period by the Physician Withdrawal Checklist and by a patient self-rating checklist. Two-hundred sixty-three patients were valid for the analysis of efficacy in the ipsapirone (N = 87), lorazepam (N = 89), and placebo (N = 87) groups.(ABSTRACT TRUNCATED AT 250 WORDS)