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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

PHILADELPHIA, May 8, 2012 /PRNewswire/ -- Today, H. Lundbeck A/S (Lundbeck) and Takeda Pharmaceutical Global Research & Development Center Inc., U.S., presented data which demonstrated significant improvements in overall symptoms of depression in elderly patients taking Lu AA21004, an investigational compound for the treatment of major depressive disorder (MDD). This study was presented at the 2012 American Psychiatric Association (APA) Annual Meeting in Philadelphia.

According to study results, elderly patients taking Lu AA21004 5mg/day showed a significantly greater (p=0.0011) improvement on the primary efficacy endpoint HAM-D24 total score versus placebo at Week 8 (mean difference to placebo of 3.3 points on the HAM-D24). Rates of HAM-D24 response (defined as a 50% or greater drop in HAM-D24 total score from baseline) were 53.2% versus 35.2% and rates of HAM-D17 remission (defined as a HAM-D17 total score less than or equal to 7) were 29.2% versus 19.3% at endpoint which were higher for Lu AA21004 than for placebo.

The study also included exploratory secondary endpoints evaluating select aspects of cognitive function. Patients on Lu AA21004 exhibited improvements from baseline compared to placebo on both, the Digit Symbol Substitution Test (DSST), a measure of processing speed, visuo-spatial attention, executive function and working memory, and the Rey Auditory Verbal Learning Task (RAVLT), a measure of verbal learning, including recall and recognition. 

"Depression is a multi-factorial disease where patients present with a variety of symptoms," said Anders Gersel Pedersen, Executive Vice President and Head of Research & Development at Lundbeck. "Having treatments to address the heterogeneity of the disease – given that the experience of depression varies so greatly from one patient to the next – is critically important to this patient population.  We are pleased that we are helping to b
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SOURCE H. Lundbeck A/S; Takeda Global Research & Development Center, Inc., U.S.
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