METHODS: JUMPs was an open-label, three-arm, randomized, parallel-group, 52-week study. Enrolled patients had schizophrenia, were ≥20 years old, and required antipsychotic treatment or switched from previous therapy. The primary endpoint was treatment discontinuation rate over 52 weeks. Secondary outcomes included remission rate, social functioning, and quality-of-life scores [Personal and Social Performance Scale (PSP) and EuroQol-5 dimensions], and safety.
RESULTS: In total, 251 patients received aripiprazole (n = 82), blonanserin (n = 85), or paliperidone (n = 84). The discontinuation rate (P = 0.9771) and remission rates (P > 0.05) over 52 weeks did not differ significantly between the three treatment groups. The discontinuation rates were 68.3%, 68.2%, and 65.5% in the aripiprazole, blonanserin, and paliperidone groups, respectively. Significant improvements (all P < 0.05) from baseline in PSP scores were observed at start of monotherapy, week 26, and week 52 in the overall cohort and blonanserin group and at week 26 in the aripiprazole group. The adverse event profile favored blonanserin.
CONCLUSIONS: All three SGAs evaluated in this study showed similar treatment discontinuation rates in patients with chronic schizophrenia in Japan.
方法:JUMPs是一个开放标签,三臂,随机化,平行组,52周的研究。登记的病人有精神分裂症,年龄≥20岁,需要抗精神病药物治疗或从以前的治疗转换。主要终点是超过52周的治疗中止率。次要结果包括缓解率,社会功能,和生活质量得分[个人和社会绩效量表(PSP)和EuroQol-5维度],和安全。
结果:总计,251例患者接受阿立哌唑(n=82),bronanserin(n=85),或帕潘立酮(n=84)。在52周内停药率(P=0.9771)和缓解率(P>0.05)在三个治疗组之间没有显着差异。停药率为68.3%,68.2%,阿立哌唑中的65.5%,blonanserin,和帕潘立酮组,分别。在单药治疗开始时观察到PSP评分相对于基线的显著改善(所有P<0.05),总体队列和布兰色林组的第26周和第52周,阿立哌唑组的第26周和第52周。不良事件概况有利于bronanserin。
结论:本研究中评估的所有三个SGA显示日本慢性精神分裂症患者的治疗中止率相似。