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

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

generalized anxiety disorder, lu AA21004, multimodal, placebo-controlled, randomized clinical trial, relapse prevention
0268-1315
197-207
Baldwin, D.S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Loft, H.
e3a6c8fb-04c2-4507-bada-17950a8deb7b
Florea, I.
43033c2d-f714-48e8-b4c5-bb16a12f463f
Baldwin, D.S.
1beaa192-0ef1-4914-897a-3a49fc2ed15e
Loft, H.
e3a6c8fb-04c2-4507-bada-17950a8deb7b
Florea, I.
43033c2d-f714-48e8-b4c5-bb16a12f463f

Baldwin, D.S., Loft, H. and Florea, I. (2012) Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. International Clinical Psychopharmacology, 27 (4), 197-207. (doi:10.1097/YIC.0b013e3283530ad7).

Record type: Article

Abstract

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.

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More information

Published date: July 2012
Keywords: generalized anxiety disorder, lu AA21004, multimodal, placebo-controlled, randomized clinical trial, relapse prevention
Organisations: Faculty of Medicine

Identifiers

Local EPrints ID: 367945
URI: https://eprints.soton.ac.uk/id/eprint/367945
ISSN: 0268-1315
PURE UUID: 68248479-6b6c-4ee0-85cb-77d8be9bf08c

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Date deposited: 09 Sep 2014 13:39
Last modified: 18 Jul 2017 01:53

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Contributors

Author: D.S. Baldwin
Author: H. Loft
Author: I. Florea

University divisions

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