Efficacy and safety of blonanserin transdermal patch in patients with schizophrenia: A 6-week randomized, double-blind, placebo-controlled, multicenter study

Nakao Iwata, Jun Ishigooka, Won Hyoung Kim, Bo Hyun Yoon, Shih Ku Lin, Ahmad Hatim Sulaiman, Rowena Cosca, Lina Wang, Yury Suchkov, Alexey Agarkov, Kei Watabe, Tomohito Matsui, Takayuki Sato, Yoshifumi Inoue, Teruhiko Higuchi, Christoph U. Correll, John M. Kane

研究成果: Article査読

20 被引用数 (Scopus)

抄録

Background: Blonanserin is a second-generation antipsychotic used for the treatment of schizophrenia. This study determined the efficacy, safety and pharmacokinetics of a blonanserin transdermal patch in patients with acutely exacerbated schizophrenia. Methods: This double-blind, multicenter, phase 3 study consisted of a 1-week observation period during which patients were treated with two patches of placebo, followed by a 6-week double-blind period where patients were randomized (1:1:1) to receive once-daily blonanserin 40 mg, blonanserin 80 mg, or placebo patches. The primary endpoint was the change from baseline in the total Positive and Negative Symptom Scale (PANSS) score. Safety assessments included treatment-emergent adverse events (TEAEs). Results: Between December 2014 and October 2018, patients were recruited and randomly assigned to blonanserin 40 mg (n = 196), blonanserin 80 mg (n = 194), or placebo (n = 190); of these, 77.2% completed the study. Compared with placebo, blonanserin significantly improved PANSS total scores at 6 weeks (least square mean [LSM] difference vs placebo: −5.6 with blonanserin 40 mg; 95% confidence interval [CI] −9.6, −1.6; adjusted p = 0.007, and − 10.4 with blonanserin 80 mg; 95% CI −14.4, −6.4; adjusted p < 0.001). Blonanserin was well tolerated; the most common TEAEs reported were application-site erythema and pruritus, akathisia, tremor, and insomnia. Conclusions: Blonanserin transdermal patch improved the symptoms of acute schizophrenia with acceptable tolerability.

本文言語English
ページ(範囲)408-415
ページ数8
ジャーナルSchizophrenia Research
215
DOI
出版ステータスPublished - 01-2020

All Science Journal Classification (ASJC) codes

  • 精神医学および精神衛生
  • 生物学的精神医学

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