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Psych Congress  

Aripiprazole Once-Monthly Maintenance Treatment of Bipolar I Disorder: A Blinded, Placebo-Controlled, Randomized Study. Effects on Symptoms and Functioning

Joseph R. Calabrese, MD; Raymond Sanchez, MD; Na Jin, MS; Joan Amatniek, MD; Kevin Cox, MD; Brian Johnson, MS; Peter Hertel, PhD; Pedro Such, MD; Margaretta Nyilas, MD; William H. Carson, MD
Otsuka Pharmaceutical Development & Commercialization, Inc. and H. Lundbeck A/S

This poster was presented at the 30th annual  Psych Congress, held Sept. 16-19, 2017, in New Orleans, Louisiana.

Objectives: To evaluate symptoms and functioning during maintenance treatment with Aripiprazole Once-Monthly 400 mg (AOM 400) in patients with Bipolar I Disorder (BP-I) stabilized for a manic episode (NCT01567527).

Methods: Patients aged 18-65 years with BP-I (DSM-IV-TR) who experienced a manic episode at enrollment were stabilized on oral aripiprazole, then on AOM 400, followed by randomization 1:1 to a 52-week double-blind, placebo-controlled withdrawal phase. Assessments included the Young-Mania Rating Scale (YMRS), the Montgomery Asberg Depression Rating Scale (MADRS), the Functioning Assessment Short Test (FAST), and the Brief Quality of Life in Bipolar Disorder (Brief QoL.BD). Changes from randomization baseline were analyzed using mixed model repeated measures approaches for YMRS and MADRS total scores, and analysis of covariance for FAST and Brief QoL.BD total scores (observed cases).

Results: After stabilization, patients randomized to AOM 400 (n=133) showed little change in mania scores, while those randomized to placebo (n=133) worsened (p<0.0016 at week 52). Depression scores were low at study entry, with no substantial changes or between-treatment differences post-randomization. Improvements in FAST scores obtained during stabilization were maintained after randomization in patients receiving AOM 400, while scores deteriorated in patients receiving placebo. No changes or between-treatment differences were seen for Brief QoL.BD scores.

Conclusions: Patients with BP-I experiencing a manic episode showed symptomatic and functional improvement during stabilization on oral aripiprazole and AOM 400. Improvements were maintained over 52 weeks for patients continued on AOM 400 treatment, but not for those switched to placebo. Depressive symptoms were not exacerbated.

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