What is the role of aripiprazole in the treatment of bipolar affective disorder (manic-depressive illness)?

Updated: May 06, 2018
  • Author: Stephen Soreff, MD; Chief Editor: Glen L Xiong, MD  more...
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Answer

In July 2017, the FDA approved aripiprazole extended-release injectable suspension (Abilify Maintena) for maintenance monotherapy of bipolar I disorder (BP-I) in adults. Approval was based on a 52-week, Phase 3, double-blind, placebo-controlled, randomized withdrawal study that enrolled patients experiencing a manic episode at screening and met the DSM-IV-TR criteria for BP-I. The primary endpoint showed once monthly aripiprazole IM significantly delayed recurrence time of any mood episode in adults having a manic episode at screening compared with placebo (P <0.0001). Significant differences were observed between treatment arms in delaying time to recurrence of both manic and mixed episodes. No substantial differences, however, were seen for depressive mood episodes. [129]


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