Efficacy and safety of brexpiprazole for the treatment of acute schizophrenia in Japan: A 6‐week, randomized, double‐blind, placebo‐controlled study. Issue 9 (2nd July 2018)

• Record Type: Journal Article
• Authors: Ishigooka, Jun; Iwashita, Shuichi; Tadori, Yoshihiro
• Is Part Of: Psychiatry and clinical neurosciences. Volume 72:Issue 9(2018)
• Page Start: 692
• Page End: 700
• Publication Date: 2018-07-02
• Subjects: brexpiprazole -- efficacy -- Japanese -- safety -- schizophrenia; Psychiatry -- Periodicals; Neurology -- Periodicals; 616.89
• DOI: 10.1111/pcn.12682
• Languages: English
• ISSNs: 1323-1316

Abstract

Abstract : Aim: This study aimed to evaluate the efficacy, safety, and tolerability of brexpiprazole compared to placebo in Japanese patients with acute schizophrenia (SCZ). Methods: We conducted a 6‐week, multicenter, double‐blind, placebo‐controlled, phase 2/3 study in Japan. Patients with acute SCZ were randomized (1:1:1:1) to receive brexpiprazole 1 mg, 2 mg, 4 mg, or placebo once a day. The primary endpoint was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total scores. Results: In the 459 patients that were randomized, brexpiprazole 2 mg showed a significant improvement versus placebo (treatment difference: −7.32, P = 0.0124), although brexpiprazole 4 mg showed numerical improvements (treatment difference: −3.86, P = 0.1959), and brexpiprazole 1 mg showed only minimal change (treatment difference: −0.63, P = 0.8330). Treatment‐emergent adverse events with an incidence of ≥5% and ≥2 times the rate of placebo in the brexpiprazole groups were vomiting, elevated blood prolactin, diarrhea, nausea, and dental caries. Most treatment‐emergent adverse events were mild or moderate in severity. There were no clinically significant changes in electrocardiogram parameters, bodyweight, laboratory values, or vital signs in the brexpiprazole groups. Conclusion: Brexpiprazole was efficacious and well tolerated in Japanese adult patients with acute SCZ.