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

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.

• Authors: Teruhiko Higuchi, Jun Ishigooka, Masaomi Iyo, Chin-Bin Yeh, Esther Gunaseli Ebenezer, Kuei Yu Liang, Jung Sik Lee, Sang Yeol Lee, Shih Ku Lin, Bo-Hyun Yoon, Masatoshi Nakamura, Katsuhiko Hagi, Takayuki Sato
• Journal: Asia-Pacific psychiatry : official journal of the Pacific Rim College of Psychiatrists (Asia Pac Psychiatry) Vol. 11 Issue 2 Pg. e12352 (Jun 2019) ISSN: 1758-5872 [Electronic] Australia
• PMID: 30950208 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: © 2019 John Wiley & Sons Australia, Ltd.

Chemical References

• Antipsychotic Agents
• Lurasidone Hydrochloride

Topics

• Adult
• Antipsychotic Agents (therapeutic use)
• Double-Blind Method
• Female
• Humans
• Japan
• Lurasidone Hydrochloride (therapeutic use)
• Malaysia
• Male
• Middle Aged
• Psychiatric Status Rating Scales
• Republic of Korea
• Schizophrenia (drug therapy)
• Taiwan
• Treatment Outcome