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Data from Study of Elderly Depressed Patients are Reported for Investigational Compound Lu AA21004 on Symptoms of Major Depressive Disorder (MDD)
Date:5/8/2012

ring additional options to people who suffer from the challenging and diverse symptoms of depression."

"These study results contribute to the growing understanding of the compound," said Stephen Brannan, M.D., Development Therapeutic Area Head, CNS, at Takeda. "Lundbeck and Takeda are committed to further investigating Lu AA21004 to better understand its mechanism of action in depression."

The study was a multi-national, randomized, double-blind, placebo-controlled, active-reference, fixed-dose study in elderly patients (n=452) with recurrent MDD, assessing the efficacy and tolerability of Lu AA21004 5 mg/day.  The primary endpoint was mean change from baseline in the 24-item Hamilton Depression Rating Scale (HAM-D24) total score, a measure of the severity of MDD.  These patients, aged 65 years or older, with a current major depressive episode (MDE) of at least 4-week duration, at least one previous MDE before the age of 60 years, a MADRS total score of 26 or more and a Mini Mental State Examination score of <24, were randomly assigned (1:1:1) to Lu AA21004 5 mg/day, duloxetine 60mg/day (active reference), or placebo for 8 weeks.

Withdrawal rates due to adverse events were 5.8% (Lu AA21004) and 2.8% (placebo). Nausea was reported with a significantly higher incidence for Lu AA21004 (21.8%) than for placebo (8.3%).

About Lu AA21004

Lu AA21004 is under investigation as a multimodal anti-depressant that is thought to work through a combination of two complementary mechanisms of actions: receptor activity modulation and reuptake inhibition.

In vitro studies indicate that LuAA21004 is a 5-HT3 and 5-HT7 receptor antagonist, 5-HT1B receptor partial agonist, 5-HT1A receptor agonist and inhibitor of the SERT. In vivo non-clinical studies have demonstrated that LuAA21004 modulates neuronal firing and neurotransmitter release in multiple systems, resulting in enhanced levels of serotonin, noradrenaline, dopamine,
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SOURCE H. Lundbeck A/S; Takeda Global Research & Development Center, Inc., U.S.
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