A 6-Week, Randomized, Double-Blind, Placebo-Controlled Study of the Efficacy and Safety of Risperidone in Adolescents with Schizophrenia

Abstract

The aim of this study was to evaluate the efficacy and safety of two dose ranges of risperidone in adolescents with schizophrenia. In a 6-week, randomized, double-blind, placebo-controlled study, adolescents aged 13-17 years with acute exacerbation of schizophrenia were randomized to placebo, flexible doses of risperidone 1-3 mg/day, or risperidone 4-6 mg/day. Assessments included the Positive and Negative Syndrome Scale (PANSS), clinical response (> or =20% reduction in PANSS total score), adverse event (AE) monitoring, and extrapyramidal symptom (EPS) scale ratings. A total of 160 subjects received placebo (n = 54), risperidone 1-3 mg/day (n = 55), or risperidone 4-6 mg/day (n = 51). Significant improvements occurred in both risperidone groups versus placebo (p < 0.001) in PANSS total change scores (placebo, -8.9 [16.1]; risperidone 1-3 mg, -21.3 [19.6]; risperidone 4-6 mg, -21.2 [18.3]) and clinical response rates (35%, 65%, 72%, respectively). Overall AE rates were more common in risperidone groups (75% and 76%) versus placebo (54%). Risperidone 4-6 mg/day had a higher incidence of extrapyramidal disorder, dizziness, and hypertonia than risperidone 1-3 mg. No prolactin-related AEs occurred. Overall EPS severity was low. Risperidone 1-3 mg/day and 4-6 mg/day were well tolerated and effective in adolescents experiencing acute episodes of schizophrenia. The benefit-risk profile suggests that a dose of 1-3 mg/day might be optimal for this population.