Research article summary (published 30 Dec 2003):

Risperidone effects in the presence/absence of psychostimulant medicine in children with ADHD, other disruptive behavior disorders, and subaverage IQ.

Full Abstract

OBJECTIVE: The aim of this study was to examine the safety and efficacy of risperidone, with or without concomitant psychostimulant use, in the treatment of children with conduct disorder (CD) or other disruptive behavior disorders [oppositional defiant disorder (ODD), disruptive behavior disorder-not otherwise specified (DBD-NOS)], and comorbid attention-deficit hyperactivity disorder (ADHD). METHODS: Data from two 6-week placebo-controlled trials assessing risperidone therapy in children with subaverage IQs and CD, ODD, DBD-NOS were combined, and patients with comorbid ADHD were selected for this post hoc analysis. Patients were grouped according to randomized drug therapy (risperidone or placebo), and then subgrouped according to their use of a concomitant psychostimulant. Safety outcomes included adverse events and weight change, while efficacy outcomes included changes in scores on disruptive behavior and hyperactivity-based subscales of two behavior-rating instruments (Nisonger Child Behavior Rating Form and the Aberrant Behavior Checklist). RESULTS: The analysis included 155 of 208 originally tested children divided into four sub-groups (35-43 patients each). There was no significant difference in the frequency of adverse events in patients who received risperidone alone and those who received risperidone plus a stimulant. The most common adverse events in risperidone-treated patients were somnolence, headache, dyspepsia, rhinitis, and vomiting. Within each randomized treatment group, actual weight gain was comparable, regardless of concomitant stimulant use. Risperidone-treated patients had clinically and statistically significant reductions in both disruptive behavior and hyperactivity subscale scores, compared to placebo, regardless of concomitant stimulant use. The addition of risperidone to a psychostimulant resulted in significantly better control of hyperactivity (p < 0.001) than was achieved with stimulant treatment alone, without causing an increase in adverse events. CONCLUSION: Risperidone was a safe and effective treatment, with or without a combined psychostimulant, for both disruptive behavior disorders and comorbid ADHD in children.

Author information

Author/s: Aman, Michael G (MG); Binder, Carin (C); Turgay, Atilla (A);

Affiliation: The Nisonger Center, Ohio State University, 1581 Dodd Drive, Columbus, OH 43210-1257, USA.

Journal and publication information

Publication Type: Clinical Trial; Journal Article; Randomized Controlled Trial

Journal: Journal of child and adolescent psychopharmacology (J Child Adolesc Psychopharmacol), published in United States. (Language: eng)

Reference: 2004-; vol 14 (issue 2) : pp 243-54

Dates: Created 2004/08/20; Completed 2004/10/26; Revised 2004/11/17;

PMID: 15319021, status: MEDLINE (last retrieval date: 2/18/2009, IMS Date: )

Sourced from the National Library of Medicine. Abstract text and other information may be subject to copyright.

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MeSH headings (categories)

This article was linked to the MESH Headings shown below.

Antipsychotic Agents - adverse effects; therapeutic use Attention Deficit Disorder with Hyperactivity - drug therapy; psychology Attention Deficit and Disruptive Behavior Disorders - drug therapy; psychology Body Mass Index Body Weight - drug effects Central Nervous System Stimulants - adverse effects; therapeutic use Child Child, Preschool Dextroamphetamine - adverse effects; therapeutic use Double-Blind Method Drug Therapy, Combination

Drug Therapy, Combination Female Humans Intelligence Intelligence Tests Male Methylphenidate - adverse effects; therapeutic use Pemoline - adverse effects; therapeutic use Psychiatric Status Rating Scales Risperidone - adverse effects; therapeutic use Treatment Outcome

Associated Chemicals: Antipsychotic Agents (0) ; Central Nervous System Stimulants (0) ; Risperidone (106266-06-2) ; Methylphenidate (113-45-1) ; Pemoline (2152-34-3) ; Dextroamphetamine (51-64-9)

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