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P01-226-Line item analysis in paediatric patients with bipolar I disorder treated with aripiprazole

Published online by Cambridge University Press:  16 April 2020

J.-Y. Loze
Affiliation:
Otsuka Pharmaceutical Development & Commercialization, Inc., Paris, France
R. Mankoski
Affiliation:
Bristol-Myers Squibb Co., Plainsboro, NJ
J. Zhao
Affiliation:
Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
W. Carson
Affiliation:
Otsuka Pharmaceutical Development & Commercialization, Inc., Princeton, NJ
E. Youngstrom
Affiliation:
Department of Psychology, University of North Carolina, Chape Hill, NC
R. Findling
Affiliation:
University Hospitals Case Medical Center/Case Western Reserve University, Cleveland, OH, USA
R. Forbes
Affiliation:
Bristol-Myers Squibb Co., Plainsboro, NJ
W. Landsberg
Affiliation:
Bristol-Myers Squibb Co., Paris, France

Abstract

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Introduction

Aripiprazole has demonstrated efficacy for the treatment of paediatric patients (10–17 years) with a manic or mixed episode associated with bipolar I disorder in a clinical trial that utilised the Young Mania Rating Scale (YMRS) Total score as the primary outcome measure.

Objectives/aim

This analysis evaluated the profile of discrete symptom response using the YMRS and other measures.

Methods

Post-hoc analysis of individual items of the YMRS and the parent or subject version of the General Behaviour Inventory (GBI) Mania and Depression scales using data from a 4-week, double-blind, randomised trial that compared aripiprazole (10 or 30 mg/day, n = 197) with placebo (n = 99).

Results

In total, 296 patients were randomised; 80% completed the study. Significant decreases at Week 4 (p < 0.05) were seen in eight YMRS items: elevated mood, increased motor activity/energy, need for sleep, irritability, speech (rate and amount), language/thought disorder, abnormal thought content and disruptive/aggressive behaviour. For the GBI, effect sizes for parent-reported mania items were medium to large (for example, 0.41 for ‘depressed but high energy’ to 0.78 for ‘rage combined with unusually happy’) but were consistently small on subject self-reported items of mania and depression and, for the overall scale, had the poorest agreement with clinician ratings.

Conclusions

Aripiprazole demonstrated improvements in some of the more troublesome symptoms of paediatric patients with bipolar I disorder experiencing an acute manic or mixed episode. Of note, irritability and aggression showed large treatment effects on both clinician and parent-reported measures, but less so for subject-reported measures.

Type
Research Article
Copyright
Copyright © European Psychiatric Association 2011
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