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Psych Congress  

Effect on Functioning With Aripiprazole Once Monthly (AOM 400) in the Long-Term Treatment of Bipolar I Disorder

Jessica Madera, MD; Na Jin, MS; Pedro Such, MD; Brian Johnson, MS; Ross A. Baker, PhD
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 assess changes in the Functioning Assessment Short Test (FAST) in a sample of de novo patients with Bipolar I Disorder (BP-I) currently taking oral aripiprazole, or newly initiating oral aripiprazole after a lapse in treatment.

Method: The trial (NCT01710709) included 3 study phases: conversion of de novo patients from their current treatment to oral aripiprazole, followed by stabilization on oral aripiprazole (4-12 weeks), after which patients meeting stabilization criteria entered a 52-week, open-label maintenance phase with AOM 400. Patients entered directly into the oral stabilization phase if they had a lapse in treatment or were already being treated with oral aripiprazole. Functioning was assessed using the FAST, a 24-item questionnaire where higher total scores (possible range: 0 to 72) reflect more impaired functioning; total scores ≥18 indicate moderate/severe impairment. Changes in FAST total score were described using observed case mean summary statistics with standard deviation (SD).

Results: At oral stabilization baseline, FAST total score indicated moderate/severe impairment (mean=17.8 [SD=13.5]; n=364). A mean improvement of -3.9 (SD=9.9) was observed at the last stabilization phase visit, and improvements were maintained over the 52-week maintenance phase AOM 400 (mean= 2.87 [SD=9.5; n=217]).

Conclusion: In this study, patients with BP-I showed functional improvements within 4 to 12 weeks after initiating oral aripiprazole. Improvements were sustained throughout 52 weeks of AOM 400 maintenance treatment.

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