Abstract | OBJECTIVE: 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.
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Authors | Michael G Aman, Carin Binder, Atilla Turgay |
Journal | Journal of child and adolescent psychopharmacology
(J Child Adolesc Psychopharmacol)
Vol. 14
Issue 2
Pg. 243-54
( 2004)
ISSN: 1044-5463 [Print] United States |
PMID | 15319021
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Antipsychotic Agents
- Central Nervous System Stimulants
- Methylphenidate
- Pemoline
- Risperidone
- Dextroamphetamine
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Topics |
- 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
- 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
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