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Effective treatments for adolescent schizophrenia are needed.
To compare efficacy and safety of two dosing regimens of risperidone.
Double-blind, 8-week study. Patients, 13–17 years, with an acute episode of schizophrenia, randomised 1:1 to risperidone 1.5–6.0 mg/day (regimen A; n=125) or 0.15–0.6 mg/day (regimen B; n=132). Trial registration number: NCT00034749.
Mean total Positive and Negative Syndrome Scale (PANSS) score improved significantly (P<0.001; effect size=0.49) from baseline to end-point for regimen A (mean=96.4 (s.d.=15.39) to mean=72.8 (s.d.=22.52)) compared with regimen B (mean=93.3 (s.d.=14.14) to mean=80.8 (s.d.=24.33)). Treatment-emergent adverse events occurred in 74% (regimen A) and 65% (regimen B) of patients; 4% of patients overall discontinued for adverse events. Mean change in body weight was 3.2 kg (s.d.=3.49) for regimen A and 1.7 kg (s.d.=3.29) for regimen B.
Adolescent patients in the regimen A group showed greater improvement in total PANSS compared with the regimen B group. Treatment was well tolerated.
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