Efficacy and safety of brexpiprazole for the treatment of acute schizophrenia in Japan: A 6-week, randomized, double-blind, placebo-controlled study

Psychiatry and Clinical Neurosciences
Jun IshigookaYoshihiro Tadori

Abstract

This study aimed to evaluate the efficacy, safety, and tolerability of brexpiprazole compared to placebo in Japanese patients with acute schizophrenia (SCZ). 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. 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 brexpi...Continue Reading

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Citations

Jan 24, 2019·Drugs·James E Frampton
Dec 17, 2019·The American Journal of Psychiatry·Stefan LeuchtJohn M Davis
Jan 19, 2020·Expert Opinion on Drug Safety·Barbara B BartonRichard Musil
Mar 7, 2020·International Clinical Psychopharmacology·Ayman Antoun ReyadRaafat Mishriky
Jul 4, 2020·Neurodegenerative Disease Management·Lauren StummerMegan Maroney
Jul 14, 2020·Expert Opinion on Drug Safety·Laura OrsoliniUmberto Volpe
Nov 19, 2019·Nihon yakurigaku zasshi. Folia pharmacologica Japonica·Mikio SuzukiTakashi Futamura
May 18, 2020·Schizophrenia Bulletin·Hiroyoshi TakeuchiStefan Leucht
Mar 10, 2021·Xenobiotica; the Fate of Foreign Compounds in Biological Systems·Hiroyuki SasabeKenji Takeuchi
Nov 5, 2021·Psychiatry Investigation·Yukako NakagamiTakahiro A Kato
Nov 30, 2021·Current Psychiatry Reports·Mehak PahwaRif S El-Mallakh

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