The purpose of this study was to investigate the long-term maintenance of the efficacy of Lu AA21004 5 or 10 mg/day in the prevention of relapse in patients with generalized anxiety disorder (GAD). Patients (n=687) with a primary diagnosis of GAD (DSM-IV criteria) and a baseline Hamilton Anxiety (HAM-A) total score of at least 20 underwent a 20-week, open-label Lu AA21004 treatment. In all, 459 patients responded and were randomized to 24–56 weeks of a double-blind treatment with Lu AA21004 (n=229) or placebo (n=230). The predefined primary efficacy endpoint was time to relapse (HAM-A total score ≥15) using a Cox model; the key secondary efficacy endpoint under multiplicity control was time to relapse for patients responding to treatment for at least 12 weeks. The primary analysis showed a statistically significant effect of Lu AA21004 relative to the placebo on the time to relapse of GAD, with a hazard ratio of 2.71 (P<0.001). There was a statistically significant effect of Lu AA21004 in the stable responders (hazard ratio=3.06, P<0.001). Lu AA21004 was well tolerated, with withdrawal rates due to adverse events of 9% (open-label) and 3% (placebo) and 4% (Lu AA21004) in the double-blind period. In this study, Lu AA21004 5 or 10 mg/day was efficacious in preventing relapse and was well tolerated in the maintenance treatment of GAD.
aClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK
bH. Lundbeck A/S, Copenhagen, Denmark
ClinicalTrials.gov Identifier: NCT00788034
Correspondence to David S. Baldwin, DM, FRCPsych, University Department of Psychiatry, Academic Centre, College Keep, 4-12 Terminus Terrace, Southampton SO14 3DT, UK Tel: +44 238 071 8520; fax: +44 238 071 8532; e-mail: email@example.com
Received January 2, 2012
Accepted February 27, 2012