Cognitive function with long-term risperidone in children and adolescents with disruptive behavior disorder.
OBJECTIVE
The aim of this study was to evaluate cognitive effects from long-term risperidone treatment for disruptive behavior disorders (DBDs) in children and adolescents.


METHODS
Patients 5-17 years old with DBDs and an intelligence quotient (IQ) > or =54 were randomized to flexibly dosed risperidone or placebo in a 6-month recurrence prevention trial. Cognitive function was assessed with a modified California Verbal Learning Test for Children (MVLT-C) and Continuous Performance Test (CPT), which assessed vigilance through computer testing with both an easy and a hard test. Somnolence was also evaluated throughout treatment. Clinically meaningful treatment effects were assessed as changes of > or =0.5 or > or =1.0 standard deviation (SD) from baseline.


RESULTS
A total of 284 subjects participating in 6-month maintenance treatment had both baseline and end point cognition assessments and were included in this analysis. Significant improvements from baseline occurred in risperidone-treated subjects for CPT hard hit rates and discrimination ability (Pr) (p < 0.05 for both), and in placebo subjects for CPT easy false alarms rates (p < 0.001) and hard Pr (p < 0.05). Both the easy and hard CPTs correct mean response time worsened with placebo. The MVLT-C short-delay free recall improved significantly for both risperidone and placebo. After adjusting for country, somnolence, age, IQ, and baseline scores, no significant differences were noted in cognition between treatment groups. Clinically meaningful changes were generally similar for risperidone and placebo patients. Mild to moderate somnolence occurred in only 2% of patients treated with either risperidone or placebo. The change in cognitive testing was not different in subjects experiencing somnolence as an adverse event (AE) compared with subjects not experiencing somnolence.


CONCLUSIONS
Risperidone treatment resulted in no decline in cognitive function among children and adolescents. These results extend on previous results from risperidone studies in DBD in patients with lower IQ.
Pandina
Gahan J
GJ
Johnson & Johnson Pharmaceutical Research & Development, Titusville, New Jersey 08560, USA. gpandina@prdus.jnj.com
Zhu
Young
Y
Cornblatt
Barbara
B
D000293:Adolescent; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000188:drug therapy* / Q000523:psychology*; D002648:Child; D002675:Child, Preschool; D003071:Cognition / Q000187:drug effects*; D005260:Female; D006801:Humans; D007361:Intelligence Tests; D008297:Male; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D055502:Secondary Prevention; D012890:Sleep / Q000187:drug effects; D016896:Treatment Outcome
D014150:Antipsychotic Agents; D018967:Risperidone