Nonresponse or a partial response to 1 or more antidepressants is a common and significant problem in clinical practice. Adjunctive therapy with atypical antipsychotics is considered as 1 of the next treatment options for such inadequate responses. The present trial evaluated the efficacy and the safety of aripiprazole as an augmentation to ongoing antidepressant monotherapy for patients with major depressive disorder (MDD) who have previously exhibited an inadequate clinical response.
This was a 6-week prospective, multicenter, open-label study with flexibly dosed adjunctive aripiprazole. The 86 participants with MDD showed inadequate responses to more than 8 weeks of standard antidepressant treatment. The primary outcome was the mean change in Montgomery-Asberg Depression Rating Scale total score from baseline to the end point (week 6).
The mean daily dose of aripiprazole at the end point was 6.9 mg. The Montgomery-Asberg Depression Rating Scale total score was significantly decreased with adjunctive aripiprazole during the study period (by 14.0 points, P = 0.000). At the end point, the response rate was 52.3% and the remission rate was 39.8%. Adjunctive aripiprazole produced a significant response and remission from week 1 through the end point. The study completion rate was 73.9%, and adverse events included sedation (n = 11), akathisia (n = 9), headache (n = 6), tremor (n = 6), and increased appetite (n = 5). Of the discontinuations, only 5.7% were due to adverse events.
Adjunctive aripiprazole in patients with MDD who had previously exhibited an inadequate response to standard antidepressant therapy was efficacious and well tolerated. A low daily dose of aripiprazole would be more acceptable in the clinical setting.