THE SAFETY AND EFFICACY OF IPSAPIRONE VS LORAZEPAM IN OUTPATIENTS WITH GENERALIZED ANXIETY DISORDER (GAD) - SINGLE-SITE FINDINGS FROM A MULTICENTER TRIAL

We report the findings of a randomized, doubleblind, placebo-controlle d, parallel, generalized anxiety disorder (GAD) outpatient study. The purpose of the study was to compare the efficacy, safety, and tolerabi lity of ipsapirone, an azapirone and 5-HT1A agonist, given at a total daily dose of 10 mg to 30 mg, with a total daily dose of 2 mg to 6 mg of lorazepam or placebo in 90 outpatients with GAD of moderate or grea ter severity. At baseline, all patients had a Hamilton Anxiety Scale ( HAM-A) score of greater-than-or-equal-to 18 and Covi anxiety score of greater-than-or-equal-to 8. After a 1-week single-blind washout, patie nts entered a 4-week double-blind period with an optional extension fo r another 4 weeks, followed by a 2-week single-blind placebo washout. Ipsapirone and lorazepam ratings on the HAM-A and Clinical Global Impr essions (CGI) were significantly (p < .05) superior to placebo at the end of the acute and maintenance periods of the trial, with a 50 perce nt HAM-A reduction on active drugs vs. 20 percent on placebo. The anxi ety of patients receiving lorazepam, but not ipsapirone, rebounded dur ing the final placebo washout.