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| |  Adjunctive Aripiprazole Therapy Effective in Patients With Depression Who Failed Previous Treatment: Presented at EPA By Jenny Powers MUNICH, Germany -- March 1, 2010 -- Data from 3 large trials showed that aripiprazole is effective in patients with major depressive disorder (MDD) who have not responded to previous antidepressant therapy, researchers said here on February 28 at the European Psychiatric Association’s (EPA) 18th European Congress of Psychiatry. Remission of MDD is the treatment goal; however, this is seen in just a minority of patients after treatment with first-line antidepressants. Therefore, augmentation with atypical antipsychotics has become a strategy to enhance response. Rossella Gismondi, MD, Bristol-Meyers Squibb Pharmaceuticals, Rome, Italy, headed an international group of researchers who conducted a subgroup analysis of data from 3 identical, short-term, double-blind, placebo-controlled studies (CN138-139, CN138-163, CN138-165) to determine the efficacy of aripiprazole in the treatment of patients with MDD who did not respond to antidepressant therapy. The primary endpoint was the mean change in the Montgomery-Asberg Depression Rating Scale (MADRS) total score in the double-blind phase The 3 studies enrolled 362, 381, and 349 patients, respectively, with MDD who did not have psychotic elements. The studies consisted of a screening washout phase followed by an 8-week phase of placebo plus antidepressant therapy, followed by a 6-week double-blind phase with antidepressant therapy plus adjunctive placebo or adjunctive aripiprazole. Subgroup analyses of the primary efficacy endpoint were performed for age, race, ethnicity, MADRS response, number and choice of previous antidepressants, episode duration, and use of selective serotonin re-uptake inhibitors. Patients in the adjunctive aripiprazole group demonstrated greater reductions in the MADRS total score across subgroups, as compared with adjunctive placebo treatment. The mean change in MADRS total score ranged from -10.71 to -5.89 with adjunctive aripiprazole and -7.57 to -4.10 with adjunctive placebo. The only statistically significant treatment-by-subgroup interaction effects observed were by gender (P = .039), with females showing a stronger response. This difference was seen only in the results of 1 study (CN138-139) and consistent results between genders in studies CN138-163 and CN138-165 were reported. The authors concluded that the results of the 3 trials demonstrated that augmentation of antidepressant treatment with aripiprazole is effective in the treatment of patients with MDD who had been unresponsive to prior antidepressant therapy. Funding for this study was provided by Bristol-Meyers Squibb Pharmaceuticals Ltd. and Otsuka Pharmaceuticals Europe, Ltd. [Presentation title: Efficacy of Adjunctive Aripiprazole in Patients With Major Depressive Disorder: Pooled Analysis of Subgroup Data From Three Clinical Trials. Abstract P01-38]
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