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-Ã…sberg Depression Rating Scale after six weeks than patients on an antidepressant and placebo, reported Robert Berman, M.D., an employee of Bristol-Myers Squibb, which licenses aripiprazole from Otsuka America.
Action Points
- Explain to patients who ask that aripiprazole (Abilify) is an atypical antipsychotic approved for the treatment of bipolar disorder and schizophrenia, but not depression.
- This study was published as an abstract and presented as a poster at a conference. These data and conclusions should be considered to be preliminary until published in a peer-reviewed publication
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-Ã…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-Ã…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<0.001).
Adverse events occurred more commonly among patients who received aripiprazole, including akathisia, which was seen in 23.1% of patients, vs. 4.5% of those on placebo; restlessness, which occurred in 14.3% of those who took both drugs compared with 3.4% of those who received an antidepressant and placebo; and headache, which occurred in 6% of patients on aripiprazole, compared with 10.8% of those on placebo (P values for differences not shown).
Aripiprazole was also associated with a weight gain of 7% or greater in 7.1% of patients, whereas only 1.2% of patients on placebo gained at least 7% of their baseline body weight.
The incidence rates of adverse events leading to discontinuation of the drugs were 1.7% for placebo, and 2.2% for aripiprazole, the authors reported.
"In patients with major depressive disorder who showed an incomplete response to standard antidepressant therapy, adjunctive aripiprazole is efficacious and well tolerated," they wrote.
| The study was funded by Bristol-Myers Squibb. The authors are all employees of the company. |
Primary Source
American Psychiatric Association 2007 Annual Meeting
Source Reference: Berman RM et al. "Efficacy And Safety Of Aripiprazole As Adjunctive Therapy In Major Depressive Disorder: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study (Study CN138-139)." Abstract 310, presented May 21.