Risperidone for the treatment of affective symptoms in children with disruptive behavior disorder: A post hoc analysis of data from a 6-week, multicenter, randomized, double-blind, parallel-arm study

Background: Despite the increasing recognition of bipolar disorder in childhood, there have been no controlled, randomized clinical trials of atypical antipsychotics in this population. Preliminary data from open-label trials in children suggest that these agents might be effective in treating pediatric bipolar disorder, however. Objective: The purpose of this post hoc analysis of data from Aman et al was to determine the effects of risperidone in the management of affective symptoms in children with disruptive behavioral disorders (DBDs). Methods: This report presents a secondary analysis of a previously reported 6-week, multicenter, double-blind, randomized, parallel-arm trial comparing 6 weeks of administration of risperidone (flexible dosing starting at 0.02 mg (.) kg(-1) (.) d(-1) and titrated up to 0.06 mg (.) kg(-1) (.) d(-1)) versus placebo in children with DBDs and subaverage intelligence. Twenty-four candidate affective symptoms of mania and depression were extracted from the 64-item Nisonger Child Behavior Rating Form (NCBRF). To define independent dimensions of mood-disorder psychopathology, these 24 symptoms were assigned 1 of 3 independent dimensions (symptoms of mania) based on loading: explosive irritability; agitated, expansive, grandiose; and depression. A fourth, nonaffective independent dimension encompassed a combination of nonaffective symptoms on the NCBRF Conduct Problem sub-scale. To assess treatment effect, each independent dimension was assigned a score derived from the sum of the symptoms that loaded on that dimension at weeks 2, 4, and 6 of study drug administration. Results: A total of 110 patients were included in the independent-dimension analysis (89 boys, 21 girls; risperidone, 49 patients; placebo, 61 patients; mean [SD] age, 8.6 [2.3] and 8.1 [2.4] years in the risperidone and placebo groups, respectively; mean [SD] weight, 33.9 [12.8] and 32.1 [12.0] kg in the risperidone and placebo groups, respectively). The treatment-effect analysis found that the mean scores of all 3 independent dimensions were significantly reduced with risperidone compared with placebo at weeks 2, 4, and 6 (all, P <= 0.03). The effect sizes of improvement in these factors ranged from 0.44 to 0.95 at end point. Conclusions: The results of this post hoc analysis of affective symptoms of DBDs using data from a previously published randomized, double-blind clinical comparison of risperidone and placebo in the treatment of children with DBDs and subaverage intelligence suggest that risperidone was effective in treating the factors of explosive irritability; agitated, expansive, grandiose; and depression.