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Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder

Baldwin, David S.a; Loft, Henrikb; Florea, Ioanab

International Clinical Psychopharmacology:
doi: 10.1097/YIC.0b013e3283530ad7
Original Articles

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.

Author Information

aClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK

bH. Lundbeck A/S, Copenhagen, Denmark 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:

Received January 2, 2012

Accepted February 27, 2012

© 2012 Lippincott Williams & Wilkins, Inc.