Efficacy, safety and tolerability of two risperidone dosing regimens in adolescent schizophrenia: double-blind study

摘要

Background Effective treatments for adolescent schizophrenia are needed. Aims To compare efficacy and safety of two dosing regimens of risperidone. Method Double-blind, 8-week study. Patients, 13a€“17 years, with an acute episode of schizophrenia, randomised 1:1 to risperidone 1.5a€“6.0 mg/day (regimen A; n =125) or 0.15a€“0.6 mg/day (regimen B; n =132). Trial registration number: [NCT00034749][1]. Results 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. Conclusions Adolescent patients in the regimen A group showed greater improvement in total PANSS compared with the regimen B group. Treatment was well tolerated. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT00034749&atom=%2Fbjprcpsych%2F194%2F2%2F158.atom