A 52-week, randomized, open-label study of aripiprazole versus blonanserin in the treatment of Japanese schizophrenia patients

抄録

Purpose: To evaluate the long-term efficacy and safety of aripiprazole and blonanserin in Japanese patients with schizophrenia.

Methods: In this 52-week, randomized, flexible-dose, open-label study, patients diagnosed with schizophrenia were randomized to receive aripiprazole (n=14) or blonanserin (n=12). The efficacy and safety of the drugs were evaluated using the Positive and Negative Syndrome Scale (PANSS) and the Clinical Global Impression-Severity Scale (CGI-S). The Drug-Induced Extrapyramidal Symptoms Scale (DIEPSS) was administered at baseline and 4, 12, 26, and 52 weeks after the initiation of treatment.

Results: Twelve patients (aripiprazole, n=7; blonanserin, n=5) completed this study. No significant differences in gender, episode, age, or PANSS total score were observed between the two groups at baseline. Both groups showed significant improvements during the study, with reductions in the total PANSS score (two-way repeated-measures ANOVA, both p < 0.01).

Discussion: In Japanese schizophrenia patients, aripiprazole and blonanserin showed comparable efficacy and tolerability during the 52-week study period. Both drugs showed good efficacy for treating schizophrenia, and the long-term therapeutic effect was maintained. Due to the high dropout rates, however, any conclusions must be considered preliminary and in need of replication.

(Clinical trial registration: UMIN000012729)