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Health Canada Expands Indications Of Abilify® (aripiprazole), To Be The First Add-On Treatment For Major Depressive Disorder (MDD)

MONTREAL, June 6, 2013 /CNW/ - Abilify® (aripiprazole) has received an additional approval from Health Canada as an adjunct, or add-on, treatment to antidepressants for the treatment of major depressive disorder (MDD) in adults who had an inadequate response to prior antidepressant treatments during the current episode. When used with an antidepressant, Abilify has been shown to improve the symptoms of adults living with MDD who had an inadequate response to at least two trials with antidepressants during the current episode. It is the first add-on treatment for MDD to be approved in Canada.

The Health Canada approval is based on results from three six-week double-blind, randomized, placebo-controlled, multicentre studies (n=1088). The results from all three studies demonstrated significant improvement in depressive symptoms in adult patients with a primary diagnosis of MDD who had experienced an inadequate response * to monotherapy with two or more antidepressants. In fact, significant improvements in depression symptoms were seen in the second week of add-on treatment with Abilify, when compared to the control.

"Even if a patient responds according to set standardized scores, they often still experience problematic residual symptoms, which can prevent a fully functional return to everyday activities.  Furthermore, these residual symptoms are a strong predictor of relapse within a relatively short timeframe," says Dr. Pierre Blier, Head of the Mood Disorders Research Unit of the Royal Ottawa Hospital and Government of Canada Chair in Psychopharmacology. "In the Canadian CANMAT treatment guidelines for the treatment of MDD - as in others around the world - Abilify is recommended for add-on to antidepressants. This new indication gives physicians and their patients with MDD an option when relief cannot be achieved with antidepressants alone."

MDD is a serious mental illness characterized by one or more major depressive episodes. The primary symptom of MDD is a sad, despairing mood, which is present most days and lasts most of the day, continues for more than two weeks, and impairs the individual's functioning at work, at school and / or in social relationships. MDD is a complex mood disorder, which is caused by several factors including genetic disposition, personality, stress, and brain chemistry. It can develop at any age, with the average age of onset in the mid-twenties.

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