Both 10- and 30-mg/day doses of aripiprazole were superior to placebo in the acute treatment of adolescents with schizophrenia. Aripiprazole was generally well tolerated.
Objective: Published studies in adult and pediatric bipolar disorder have used different definitions of treatment response. This analysis aimed to compare different definitions of response in a large sample of children and adolescents. Methods: Anexploratory analysis of a 4-week, multicenter, placebo-controlled study assessed patients (n = 296; ages, 10-17 years) with an acute manic/mixed episode associated with bipolar I disorder who were randomized to aripiprazole (10 or 30 mg/day) or placebo. The primary efficacy endpoint was mean change from baseline to week 4 in Young Mania Rating Scale (YMRS) total score. Additional assessments included: Clinical Global Impressions-Bipolar Disorder (CGI-BP) Overall and Mania scales, Child Global Assessment Scale (CGAS), and parent and subject General Behavior Inventory. Response was compared across seven operational definitions. Cohen's j and Spearman's correlation tested relationships between various response definitions or changes in outcome measures and clinically meaningful improvement (defined as a CGI-BP Overall Improvement score of 1 or 2). Results: Response rates varied depending upon the operational definition, but were highest for 95% reliable change (statistical method used to determine individual change from previous assessment) and ‡ 33% reduction in YMRS total score. Response rate definitions with the highest validity in terms of predicting clinically meaningful improvement were: ‡ 50% reduction on YMRS (j = 0.64), a composite definition of response (YMRS < 12.5, Children's Depression Rating ScaleRevised (CDRS-R) £ 40, and CGAS ‡ 51; j = 0.59), and 95% reliable change on the CGAS or 33% reduction on YMRS (j = 0.56). Parent ratings of symptoms were generally better at detecting symptom improvement than were subject ratings (j = *0.4-0.5 vs. *0.2 when compared with CGI-BP Overall Improvement score). Conclusions: Clinically meaningful definitions of response in acute treatment of a manic/mixed episode in pediatric subjects include a 50% change in YMRS and a composite measure of response. Parent-reported measures of symptom improvement appear reliable for assessing symptom change.
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