A multicenter, randomized, double-blind, controlled phase 3 trial of fixed-dose brexpiprazole for the treatment of adults with acute schizophrenia
Publication Date
2015
Journal Title
Schizophr Res
Abstract
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.
Volume Number
164
Issue Number
1-3
Pages
127-135
Document Type
Article
EPub Date
2015/02/16
Status
Faculty
Facility
School of Medicine
Primary Department
Psychiatry
Additional Departments
Molecular Medicine
PMID
DOI
10.1016/j.schres.2015.01.038