Journal of the American Academy of Child & Adolescent Psychiatry
ARTICLESRisperidone Augmentation for Treatment-Resistant Aggression in Attention-Deficit/Hyperactivity Disorder: A Placebo-Controlled Pilot Study
Section snippets
METHOD
This study was a 28-day, double-blind, placebo-controlled trial of risperidone as an augmenting agent in children, 7 to 12 years of age, with ADHD. The study was conducted in accordance with the Declaration of Helsinki and was approved by the Human Subjects Research Office of the University of Miami Miller School of Medicine. Patients were required to provide assent before participation and the patient's parent or legal guardian had to provide written consent. A subject could withdraw from the
Patient Characteristics
Twenty-five subjects participated in the study, with 12 assigned to risperidone treatment and 13 assigned to placebo. No statistically significant differences were found for age, gender, race, weight, body mass index (BMI), Aggression Questionnaire Predatory-Affective index score, CAS-P total score, or CAS-T total score between the treatment groups at baseline (Table 1). Comorbid diagnoses were found in 16 subjects. These included oppositional defiant disorder (n = 13), conduct disorder (n =
DISCUSSION
This study is the first randomized, placebo-controlled, double-blind trial of risperidone augmentation for treatment-resistant aggression in children with ADHD. As a pilot study this trial was designed for hypothesis generation and not as a definitive test of efficacy. Results of this study do not provide convincing evidence that augmentation of stimulant treatment with risperidone in aggressive children with ADHD is an effective treatment strategy. Risperidone augmentation of psychostimulant
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This study was supported by Janssen, LP.
Disclosure: Dr. Armenteros has received research support and is on the speakers' panel of Janssen Pharmaceutica. The other authors have no financial relationships to disclose.