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Risperidone Reduces Aggression in Children With Disruptive Behaviour Disorders: Presented at ECNP

By Paula Moyer

PRAGUE, CZECH REPUBLIC -- October 14, 2003 -- The atypical antipsychotic risperidone (Risperdal) is effective at reducing aggressive behaviour in boys who have different types of disruptive behaviour disorders (DBD), according to findings presented here September 24^th at the 16^th World Congress of the European College of Neuropsychopharmacology.

"These results show that risperidone is effective in treating aggression in the treatment-resistant child," said lead author Carin Binder, MBA, director of clinical affairs, Janssen-Ortho, Toronto, Ontario, Canada, which manufactures Risperdal. "Over 70% of the patients in the study had attention deficit hyperactivity disorder [ADHD] [that] had been treated, but [there were] still…problems with aggression at baseline." The principal investigator for this study was John LeBlanc, MD, paediatrician and epidemiologist, Dalhousie University, Halifax, Nova Scotia, Canada.

The investigators analysed risperidone's effect on core aggression symptoms by combining data collected involving 163 boys in two previous double-blind clinical trials. Other research had shown that risperidone was effective in treating conduct disorder (CD) and oppositional defiant disorder (OD) in children without ADHD. In the current research, the investigators used the Nisonger Child Behaviour Rating Form (NCBRF) to assess efficacy.

The boys ranged in age from 5 to 12 years old, with an average age of 8.7 years, and had diagnoses of DBD, which was defined as either CD or OD, as defined by the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition Revision IV (DSM-IV) and who scored at least 24 on the Conduct Problem subscale of the NCBRF. Their parents served as raters.

The subjects were randomised to receive either placebo or oral risperidone at a dosage range of 0.02 to 0.06 mg/kg daily. The treatment period consisted of six weeks. The investigators selected six items of the NCBRF as core items of aggression: item 4, cruel or mean to others; item 8, knowingly destroying property; item 17, explosive, easily angered; item 26, getting into physical fights; item 36, physically attacking people; and item 57, threatening people.

The investigators conducted factor analyses on the core aggression-item scores at baseline to quantify the number of aggression factors accounting for aggression. They then calculated descriptive statistics for the change in aggression score from baseline to endpoint by diagnosis: CD or OD, and whether comorbid ADHD was present or absent. The investigators also developed modifiers of response to treatment that consisted of baseline symptoms in the categories of "defiance", "self harm" and "emotional regulation". The team also considered other potential predictors of treatment response, such as diagnosis, age and intelligence quotient (IQ), and conducted regression analyses to identify the variables that would affect response to treatment.

The boys' baseline aggression scores averaged 10.7 (SD 4.3) in the risperidone group and 11.4 (SD 4.3) in the placebo group. The aggression item scores at baseline were reasonably consistent with a Cronbach's coefficient alpha of 0.70. The aggression score from baseline to endpoint decreased an average of 5.8 (SD 4.6) and 2.4 in the placebo (SD 5.4) (p<0.0001 between groups).

Among the different diagnoses, the changes in aggression scores in the risperidone arm were 6.0 in boys with CD and ADHD, 6.5 for those with only CD, 5.7 for those with OD and ADHD, and 5.2 for those with only OD. In the placebo arm, the responses by diagnosis were 2.4 for CD and ADHD, 3.5 for those with only CD, 1.3 for those with OD and ADHD, and 3.2 for those with only OD.

When the investigators conducted a principal factor analysis of the baseline aggression item scores at baseline, they found that the items could be explained by one factor: high baseline scores were associated with a more robust treatment response. They found no consistent relationship between treatment response over time and the variables of diagnosis, age, IQ, defiance, self-harm and emotional regulation.

Janssen-Ortho funded this study.


[Study title: Effects of Risperidone Versus Placebo on Aggression in Children With Disruptive Behaviour Disorders. Abstract P6-066]

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