Treating disruptive behavior disorders with risperidone: a 1-year, open-label safety study in children and adolescents.
OBJECTIVE
The aim of this study was to determine the long-term safety of risperidone as maintenance therapy in children and adolescents with disruptive behavior disorders (DBDs) and normal intelligence.


METHODS
An open-label, 1-year extension study was conducted from January, 2002, to July, 2004, in 232 subjects with DBDs (5-17 years) previously randomized to risperidone (RIS) (n = 115, RIS/RIS) or placebo (PLA) (n = 117, PLA/RIS) in a double-blind, 6-month withdrawal study. Adverse events (AEs) and clinical laboratory test results were recorded. Efficacy was assessed using Nisonger Child Behavior Rating Form. Safety and efficacy were evaluated in the intent-to-treat population.


RESULTS
A total of 169/232 (73%) subjects completed the study. Subjects were predominantly male, with a diagnosis of oppositional defiant disorder. Risperidone was generally well tolerated. Weight gain and extrapyramidal symptoms were each reported as AEs by 10 subjects (4.3%). Mean weight z-scores decreased for RIS/RIS subjects (-0.04 +/- 0.28) and increased for PLA/RIS subjects (0.11 +/- 0.43). No subject developed tardive dyskinesia. Prolactin tended to increase with risperidone, although this effect diminished with prolonged use and was infrequently associated with AEs. There were no clinically relevant changes in glucose or lipid metabolism. Clinical improvement in DBD symptoms was observed with flexible risperidone doses, regardless of previous treatment and whether subjects had experienced symptom recurrence.


CONCLUSIONS
Risperidone reinitiated for DBD in children with normal intelligence quotients (IQ) was safe and well tolerated over an additional year of treatment. Patients demonstrated clinical benefits, including those who previously experienced symptom recurrence.
Haas
Magali
M
Johnson & Johnson Pharmaceutical Research and Development, Titusville, New Jersey 08530, USA. mhaas9@prdus.jnj.com
Karcher
Keith
K
Pandina
Gahan J
GJ