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U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) as the First Medication for Add-On Treatment of Major Depressive Disorder (MDD)
Date:11/20/2007

ADTs, including selective serotonin reuptake inhibitors (SSRIs): Lexapro(R) (escitalopram), Prozac(R) (fluoxetine), Paxil CR(R) (paroxetine controlled-release), Zoloft(R) (sertraline); or a serotonin-norepinephrine reuptake inhibitor (SNRI): Effexor XR(R) (venlafaxine extended release). The dosage range for adjunctive ABILIFY was 2-20 mg/day (15 mg/day was the maximum dose for patients receiving ABILIFY as an adjunct to Paxil CR or Prozac).

The primary efficacy endpoint was the mean change from baseline -- the end of the prospective treatment phase -- to the end of the randomized treatment phase in a standard measure called Montgomery-Asberg Depression Rating Scale (MADRS), a 10-item clinician-rated scale used to assess depressive symptoms. A reduction in MADRS Total Score represents an improvement in depressive symptoms. The key secondary endpoint was the Sheehan Disability Scale (SDS), a three-item self-rated instrument used to assess the impact of depression on three domains of functioning (work/school, social life and family life) with each item scored from zero (not at all) to 10 (extreme). Safety evaluations included incidence of adverse reactions, discontinuation rate due to adverse reactions and laboratory measures.

For the primary endpoint, both studies showed that taking ABILIFY plus an ADT provided superior improvement in depressive symptoms to ADT alone at study endpoint (week six), as measured by the reduction of the MADRS Total Scores.(3) For the secondary endpoint, ABILIFY plus an ADT was also superior to placebo plus ADT in reducing the mean SDS Total Score in one study.

In these studies, adjunctive ABILIFY demonstrated no clinically important differences on metabolic parameters, including prolactin, fasting glucose, HDL, LDL and total cholesterol. The median percent change from baseline in triglycerides was 5 percent for adjunctive ABILIFY-treated patients vs 0 percent for adjunctive placebo-treated patients. In the studies, weight
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SOURCE Bristol-Myers Squibb Company and Otsuka PharmaceuticalCo., Ltd.
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