期刊
SCHIZOPHRENIA RESEARCH
卷 164, 期 1-3, 页码 127-135出版社
ELSEVIER
DOI: 10.1016/j.schres.2015.01.038
关键词
Schizophrenia; Phase 3 trial; Brexpiprazole; Efficacy; Safety; Acute
类别
资金
- Otsuka Pharmaceutical Development & Commercialization, Inc. (Princeton, USA)
- H. Lundbeck A/S (Valby, Denmark)
The objective of this study was to evaluate the efficacy, safety and tolerability of brexpiprazole versus placebo in adults with acute schizophrenia. This was a 6-week, multicenter, placebo-controlled double-blind phase 3 study. Patients with acute schizophrenia were randomized to brexpiprazole 1, 2 or 4 mg, or placebo (2: 3: 3: 3) once daily. The primary endpoint was changed from baseline at week 6 in Positive and Negative Syndrome Scale (PANSS) total score; the key secondary endpoint was Clinical Global Impressions-Severity (CGI-S) at week 6. Brexpiprazole 4 mg showed statistically significant improvement versus placebo (treatment difference: -6.47, p = 0.0022) for the primary endpoint. Improvement compared with placebo was also seen for the key secondary endpoint (treatment difference: -0.38, p = 0.0015), and on multiple secondary efficacy outcomes. Brexpiprazole 1 and 2 mg also showed numerical improvements versus placebo, although p > 0.05. The most common treatment-emergent adverse events were headache, insomnia and agitation; incidences of akathisia were lower in the brexpiprazole treatment groups (4.2%-6.5%) versus placebo (7.1%). Brexpiprazole treatment was associated with moderate weight gain at week 6 (1.23-1.89 kg versus 0.35 kg for placebo); there were no clinically relevant changes in laboratory parameters and vital signs. In conclusion, brexpiprazole 4 mg is an efficacious and well-tolerated treatment for acute schizophrenia in adults. (C) 2015 Elsevier B.V. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据