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Six-Week Investigational Study In Adults With Major Depressive,Disorder Evaluates The Effectiveness of Adjunctive Aripiprazole,Therapy With Antidepressants

the six-week randomized treatment phase during which they continued their ADT plus double-blind adjunctive placebo or adjunctive aripiprazole (2-20 mg/day).

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 the MADRS Total Score, which can range from 0 (no symptoms) to 60 points (most severe symptoms). A reduction in MADRS Total Score represents improvement in depressive symptoms. Some of the secondary endpoints included Sheehan Disability Scale (SDS), MADRS-measured remission and response rates and Clinical Global Impression-Severity of Illness (CGI-S) score.

For the primary endpoint, the study showed that adults taking adjunctive aripiprazole had a greater reduction in MADRS Total Score from baseline compared to placebo (-8.8 vs. -5.8 points, p-value less than 0.001).

The discontinuation rate due to an adverse event for adults taking add-on aripiprazole was 3.3 percent and 2.3 percent for placebo. The most common adverse events in the add-on aripiprazole and add-on placebo groups, respectively, (greater than or equal to 5 percent and at least twice the incidence of placebo) were akathisia (23.1 percent vs. 4.5 percent), insomnia (7.7 percent vs. 2.3 percent), restlessness (14.3 percent vs. 3.4 percent), upper respiratory tract infection (8.2 percent vs. 4 percent), and blurred vision (6.6 percent vs. 1.7 percent).

About Major Depressive Disorder

Major depressive disorder (MDD) is characterized by one or more major depressive episodes, (i.e., at least two weeks of depressed mood or loss of interest accompanied by at least four additional symptoms of depression.) (2) It affects 6.7 percent of American adults (approximately 15 million individuals) in a given year(3) and is the most common mental health disorder after anxiety.(4)

About Aripiprazole

Aripiprazole is indicated for the treat
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