| Lu AA21004, a multimodal psychotropic agent, in the prevention of relapse in adult patients with generalized anxiety disorder. | |
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MedLine Citation:
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PMID: 22475889 Owner: NLM Status: Publisher |
Abstract/OtherAbstract:
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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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Authors:
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David S Baldwin; Henrik Loft; Ioana Florea |
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Publication Detail:
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Type: JOURNAL ARTICLE Date: 2012-4-3 |
Journal Detail:
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Title: International clinical psychopharmacology Volume: - ISSN: 1473-5857 ISO Abbreviation: - Publication Date: 2012 Apr |
Date Detail:
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Created Date: 2012-4-5 Completed Date: - Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 8609061 Medline TA: Int Clin Psychopharmacol Country: - |
Other Details:
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Languages: ENG Pagination: - Citation Subset: - |
Affiliation:
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aClinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK bH. Lundbeck A/S, Copenhagen, Denmark. |
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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