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Psych Congress  

Course of Two Common Adverse Events in Aripiprazole Once-Monthly Maintenance Treatment of Bipolar I Disorder During a Double-Blind, Placebo-Controlled, Randomized Withdrawal Study

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.

Objective: To characterize the course of adverse events (AE) of akathisia and weight gain during >1 year of maintenance treatment with Aripiprazole Once-Monthly 400 mg (AOM 400) for Bipolar I Disorder (BP-I).

Methods: In this double-blind withdrawal study (NCT01567527), patients aged 18-65 years diagnosed with BP-I (DSM-IV-TR) were stabilized on oral aripiprazole, then on AOM 400; patients who met stabilization criteria were then randomized 1:1 to 52-weeks' placebo-controlled AOM 400 maintenance treatment. AEs of akathisia and weight gain were characterized using descriptive statistics.

Results: Of 731 patients enrolled, 720 received >1 dose of aripiprazole, oral or oral+intragluteal injection. Of the enrolled, 141/731 (19.3%) discontinued due to AEs; 8/266 (3.0%) after randomization. The most common AEs were akathisia and weight gain, reported in 169/720 (23.5%) and 76/720 (10.6%), respectively.

The median onset of akathisia was 20 days after first dose of [oral] aripiprazole (median duration of first occurrence = 29 days). Of 39 new occurrences after patients began AOM 400 treatment, 30 (76.9%) occurred in the first 3 months. Discontinuation due to akathisia was minimal (<2.0% in any study phase).

Patients randomized to AOM 400 gained a mean (SD) weight of 2.4 (7.2) kg from beginning AOM 400 stabilization to last visit. The mean weight gain relative to baseline was <3.0 kg at any visit and appeared to plateau after 36 weeks.

Conclusion: This study indicates that AEs of akathisia and weight gain during AOM 400 treatment are manageable and support AOM 400 as a well-tolerated maintenance treatment of BP-I.

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