APA: Abilify Has Adjunctive Antidepressant Effect

May 23, 2007

SAN DIEGO -- Aripiprazole (Abilify) may be a useful adjunctive therapy in patients with major depressive disorders who have incomplete responses to antidepressants, researchers reported here.

SAN DIEGO, May 23 -- Aripiprazole (Abilify) may be a useful adjunctive therapy in patients with major depressive disorders who have incomplete responses to antidepressants, researchers reported here.

In a randomized study, patients assigned to antidepressants and aripiprazole had a significantly better reduction in scores on the Montgomery-sberg Depression Rating Scale after six week than patients on an antidepressant and placebo, reported Robert Berman, M.D., an employee of Bristol-Myers Squibb, which licenses aripiprazole from Otsuka America.

Aripiprazole is approved by the FDA for the treatment of schizophrenia and bipolar disorder, not for adjunctive treatment of depression.

The study, presented at the American Psychiatric Association meeting, involved a screening phase lasting from seven to 28 days, an eight-week prospective treatment phase during which patients received standard antidepressants, and a placebo-controlled six-week randomization phase.

The investigators enrolled patients with major depressive disorder who had had an incomplete response to one or more antidepressants and who had an incomplete response during the eight-week prospective phase.

During the prospective phase, patients who experienced a major depressive episode, defined as a Hamilton Depression Rating Scale (HAM-D17) total score of 18 or greater, received one of the following antidepressants, dosed according to the label guidelines: escitalopram (Lexapro), fluoxetine (Prozac), paroxetine (Paxil) CR, sertraline (Zoloft) CR, or venlafaxine (Effexor) XR. Each drug was administered with a single-blind, adjunctive placebo.

Patients who had an incomplete response to the therapy were then randomized to either continued adjunctive placebo or adjunctive aripiprazole (2 to 20 mg/day).

The primary efficacy endpoint was a mean change in Montgomery-sberg Depression Rating Scale total from the end of the prospective phase to the end of the randomized phase. The total score at week 14, last observation carried forward, was assessed by analysis of covariance, with the end of prospective treatment as a covariate, and the treatment and study center as main effects.

A total of 178 patients were randomized to adjunctive placebo and 184 to adjunctive aripiprazole; baseline demographics were similar between the treatment groups, with a mean Montgomery-sberg Depression Rating Scale score of 26.0.

The authors found that the mean change in the rating scale score was significantly larger for patients on the antidepressant/aripiprazole combination compared with those on placebo, at -8.8 vs. -5.8, respectively (P