Aripiprazole in major depressive disorder

Investigational studies are important because a number of patients with major depressive disorder do not achieve adequate symptom response, said study investigator Arif Khan, M.D., Medical Director, Northwest Clinical Research Center, Bellevue, Wash., and Adjunct Professor, Psychiatry, Duke University, Durham, N.C. The findings from this study contribute more information about the potential use of add-on medications to antidepressant treatment in patients who inadequately respond to antidepressants alone.

Study Design and Findings
This double-blind, randomized, placebo-controlled, multi-center, six-week study enrolled adults diagnosed with major depressive disorder who had an inadequate response to one or more ADTs. After a seven to 28-day screening phase, adults in this study underwent an eight-week prospective therapy phase with one ADT plus single-blind placebo to confirm their inadequate response to ADT. The ADTs included escitalopram, fluoxetine, paroxetine controlled release, sertraline or venlafaxine extended release, dosed per label guidelines. A total of 362 adults with inadequate response then entered the six-week randomized therapy 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 therapy phase to the end of the randomized therapy 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 in comparison 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 occurence rate 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).


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