Lurasidone in the treatment of schizophrenia: Results of a double‐blind, placebo‐controlled trial in Asian patients

作者：Teruhiko Higuchi, Jun Ishigooka, Masaomi Iyo, Chin‐Bin Yeh, Esther Gunaseli M. Ebenezer, Kuei Yu Liang, Jung Sik Lee, Sang-Yeol Lee, Shih‐Ku Lin, Bo‐Hyun Yoon, Masatoshi Nakamura, Katsuhiko Hagi, Takayuki Sato · 发表于：Asia-Pacific Psychiatry · 年份：2019 · DOI：10.1111/appy.12352 · 被引用次数：37 · 研究领域：Schizophrenia research and treatment、Treatment of Major Depression、Tryptophan and brain disorders

INTRODUCTION: To evaluate efficacy and safety of lurasidone for the treatment of Asian patients with schizophrenia. METHODS: Patients with schizophrenia from Japan, South Korea, Malaysia, and Taiwan were randomly assigned to 6 weeks of double-blind treatment with 40 or 80 mg/d of lurasidone or placebo. The primary efficacy measure was change from baseline to week 6 on the Positive and Negative Syndrome Scale (PANSS) total score. Efficacy was evaluated using a mixed-model repeated-measures (MMRM) analysis in the modified intention-to-treat (mITT) population. RESULTS: On the basis of the analysis for the mITT population, the estimated difference score for lurasidone 40 and 80 mg/d vs placebo was -4.8 (P = 0.050) and -4.2 (P = 0.080). For the full intention-to-treat (ITT) population, the difference score for lurasidone 40 and 80 mg/d vs placebo was -5.8 (P = 0.017) and -4.2 (P = 0.043). The most frequent adverse events in the lurasidone 40 and 80 mg/d and placebo groups, respectively, were akathisia (7.3%, 10.4%, 3.3%), somnolence (6.0%, 2.6%, 0.7%), and vomiting (6.0%, 5.8%, 2.0%). The proportion of patients experiencing clinically significant weight gain (≥7%) was 5.3% for lurasidone 40 mg/d, 1.3% for 80 mg/d, and 1.4% for placebo. End point changes in metabolic parameters and prolactin were comparable for both lurasidone groups and placebo. CONCLUSIONS: In the ITT (but not the mITT) population, treatment with lurasidone was associated with significant improvement in the PANSS...