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

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of two dose ranges of risperidone in adolescents with schizophrenia. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.