Efficacy and Safety of Aripiprazole Once-monthly in Patients With Relatively Rapid and Non-Rapid Cycling Bipolar I Disorder

Objective: To assess the efficacy and safety of Aripiprazole Once-Monthly (AOM 400) in preventing recurrence of mood episodes in patients with rapid and non-rapid cycling Bipolar I disorder (BP-I). The established role of oral aripiprazole in the treatment of BP-I and the potential for a long-acting injectable formulation to improve adherence and prevent recurrence of mood episodes led to the evaluation of AOM 400 mg in the maintenance treatment of BP-I. The objective of this post hoc analysis was to assess the efficacy and safety of AOM 400 mg in preventing recurrence of mood episodes in patients with non-rapid cycling and relatively rapid cycling BP-I patients.

Methods: The primary objective of open-label trial (NCT01710709) was to evaluate the effectiveness of an intramuscular (IM) depot AOM as maintenance treatment in BP I. Rapid cyclers (≥ 9 episodes in the past year) were excluded from the study. For this analysis, relatively rapid cycling was defined as cycling four or more manic, hypomanic, or depressive episodes in the past 12-month period.

Results: Overall, both the time to recurrence of any mood episode and the proportion of recurrences was similar during the duration of the study. Recurrence occurred in:  93/385 (24.2%)of non-rapid cyclers and in 21/78 (26.9%) of relatively rapid cyclers.

Conclusions: In this post-hoc analyses, AOM 400 reductions in the time to recurrence and recurrence of mood episodes in both non-rapid and relatively rapid cyclers was similar.