The present report addresses the occurrence of depression during a multicenter, double‐blind, randomized, placebo‐controlled trial investigating the comparative anxiolytic efficacy of ipsapirone and lorazepam versus placebo in generalized anxiety disorder (GAD). Patients who entered the study scored ≥18 on the HAM‐A, scored ≥ 8 on the Covi anxiety scale, and scored ⩽ 7 on the Raskin depression scale. Patients were randomized to lorazepam (2–6 mg/day), ipsapirone (10–30 mg), or placebotid for 4 weeks acute treatment. Efficacy of ipsapirone versus lorazepam and placebo in GAD was assessed with weekly HAM‐A and CGI ratings. Worsening or emergence of depression was assessed with HAM‐D ratings performed at baseline and weeks 2 and 4. Adverse events were assessed weekly. Ninety‐six males and 161 females (age range 18–78 years) were valid for efficacy after a 4‐week acute treatment period. HAM‐A and CGI scores were significantly reduced with lorazepam and ipsapirone compared with placebo. HAM‐D scores were also reduced significantly from baseline in the lorazepam, ipsapirone, and placebo groups; HAM‐D core items significantly decreased in the ipsapirone but not in the lorazepam and placebo groups. Individual incidents of depression showed significantly (p < 0.05) higher frequency in the lorazepam group (10/104; 9.6%) compared with ipsapirone (2/106; 1.9%), but only a trend (p < 0.10) compared with placebo (4/105; 3.8%). There was an increased severity of the depressive incidents in the lorazepam group compared with the other two treatment groups. This report confirms an earlier study reporting that depression is a potential side effect of lorazepam treatment in GAD patients. Depression 1:172–176 (1993). © 1993 Wiley‐Liss, Inc.
- generalized anxiety disorder