Effects of Aripiprazole Once-monthly (AOM) Across Manic Symptoms in Patients with Bipolar I Disorder (BP-I)

Background: The established role of oral aripiprazole in the treatment of Bipolar I disorder (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 in the maintenance treatment of BP-I. The objective of this post-hoc analysis was to assess the efficacy of AOM 400 on individual The Young Mania Rating Scale (YMRS) line items in adult patients with BP-I. The YMRS consists of 11 items assessing the core symptoms of mania. Negative scores represent improvements while higher scores represent more severe mania.

Methods: In a double-blind, placebo-controlled, 52-week randomized withdrawal study (NCT01567527), patients with a DSM-IV-TR diagnosis of BP-I currently experiencing a manic episode were stabilized sequentially on oral aripiprazole and AOM 400 and then randomized to AOM 400 or placebo. Mean change in YMRS line items from baseline to week 52 were analyzed using a Mixed Model Repeated Measure (MMRM) approach.

Results: At 52 weeks beneficial effects were observed in 9 out of 11 YMRS line items (change from baseline) with AOM vs. placebo: elevated mood (-0.03 vs. 0.03); motor activity energy (-0.16 vs. 0.03); sexual interest (-0.06 vs. 0.05); sleep (-0.14 vs. 0.05); irritability (-0.13 vs. 0.23); speech (-0.03 vs. 0.38); language (-0.14 vs. 0.13); content (0.11 vs. 0.26), disruptive aggressive behaviors (0.06 vs. 0.23), appearance (0.08 vs. -0.05), insight (-0.06 vs. -0.10).

Conclusions: In this post-hoc analyses, AOM 400 resulted in long term improvements in the manic symptoms of BP I.