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Efficacy and safety of lurasidone in acutely psychotic patients with schizophrenia: A 6‐week, randomized, double‐blind, placebo‐controlled study
Author(s) -
Iyo Masaomi,
Ishigooka Jun,
Nakamura Masatoshi,
Sakaguchi Reiko,
Okamoto Keisuke,
Mao Yongcai,
Tsai Joyce,
Fitzgerald Alison,
Nosaka Tadashi,
Higuchi Teruhiko
Publication year - 2021
Publication title -
psychiatry and clinical neurosciences
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.609
H-Index - 74
eISSN - 1440-1819
pISSN - 1323-1316
DOI - 10.1111/pcn.13221
Subject(s) - lurasidone , placebo , akathisia , discontinuation , positive and negative syndrome scale , adverse effect , clinical endpoint , medicine , clinical global impression , randomized controlled trial , schizophrenia (object oriented programming) , antipsychotic , psychology , anesthesia , psychiatry , psychosis , alternative medicine , pathology
Aim The aim of this study was to evaluate the efficacy of lurasidone in acute schizophrenia in Japan and other countries. Methods Subjects (aged 18–74 years) diagnosed with schizophrenia were randomized to lurasidone 40 mg/day or placebo. The primary efficacy endpoint was change from baseline on the Positive and Negative Syndrome Scale (PANSS) total score at Week 6. Secondary efficacy assessments included the Clinical Global Impression‐Severity Scale (CGI‐S). Safety endpoints included adverse events, and laboratory and electrocardiogram parameters. Results A total of 483 subjects were randomized to lurasidone or placebo; 107 subjects were from Japan. Mean changes from baseline at Week 6 endpoint in PANSS total scores were −19.3 in the lurasidone group and −12.7 in the placebo group (treatment difference: P < 0.001, effect size = 0.41). Changes from baseline for Week 6 CGI‐S scores were −1.0 for lurasidone and −0.7 for placebo (treatment difference: P < 0.001, effect size = 0.41). All‐cause discontinuation during the 6‐week, double‐blind period was 19.4% for lurasidone and 25.4% for placebo, and discontinuation rates due to adverse event were 5.7% for lurasidone and 6.4% for placebo. The following common treatment‐emergent adverse events occurred in more than 2% on lurasidone and at a rate at least twice that of the placebo group: akathisia (4.0%), dizziness (2.8%), somnolence (2.8%), abdominal discomfort (2.0%) and asthenia (2.0%). No significant changes in bodyweight or metabolic parameters were observed. Conclusion Lurasidone 40 mg once daily dosing demonstrated efficacy in a patient population with acute schizophrenia, including subjects from Japan, and was generally safe and well‐tolerated.