Teruhiko Higuchi1, Jun Ishigooka2, Masaomi Iyo3, Chin-Bin Yeh4, Esther Gunaseli Ebenezer5, Kuei Yu Liang6, Jung Sik Lee7, Sang Yeol Lee8, Shih Ku Lin9, Bo-Hyun Yoon10, Masatoshi Nakamura11, Katsuhiko Hagi11,12, Takayuki Sato11,13. 1. Japan Depression Center, Tokyo, Japan. 2. Institute of CNS Pharmacology, Tokyo, Japan. 3. Department of Psychiatry, National University Corporation Chiba University, Graduate School of Medicine, Chiba, Japan. 4. Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, Taipei, Taiwan. 5. Hospital Raja Permaisuri Bainun, UniKL Royal College of Medicine Perak, Ipoh, Malaysia. 6. Department of Psychiatry, Wei-Gong Memorial Hospital, Toufen City, Taiwan. 7. Department of Psychiatry, Yongin Mental Hospital, Yong-in City, South Korea. 8. Department of Psychiatry, Wonkwang University School of Medicine and Hospital, Iksan, South Korea. 9. Department of Psychiatry, Taipei City Hospital SongDe Branch, Taipei, Taiwan. 10. Department of Psychiatry, Naju National Hospital, Naju, South Korea. 11. Data Science, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan. 12. Medical Affairs, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan. 13. Clinical Operations, Sumitomo Dainippon Pharma Co., Ltd., Tokyo, Japan.
Abstract
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 total score in patients with schizophrenia. Lurasidone was generally well tolerated with minimal impact on weight and metabolic parameters.
RCT Entities:
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 total score in patients with schizophrenia. Lurasidone was generally well tolerated with minimal impact on weight and metabolic parameters.