Efficacy and Safety of Lurasidone vs. Quetiapine XR in Acutely Psychotic Patients With Schizophrenia in Korea: A Randomized, Double-Blind, Active-Controlled Trial

Kim, Se Hyun; Jung, Do-Un; Kim, Do Hoon; Lee, Jung Sik; Lee, Kyoung-Uk; Won, Seunghee; Lee, Bong Ju; Kim, Sung-Gon; Roh, Sungwon; Park, Jong-Ik; Kim, Minah; Jung, Sung Won; Oh, Hong Seok; Jung, Han-yong; Kim, Sang Hoon; Chee, Hyun Seung; Paik, Jong-Woo; Lee, Kyu Young; Kim, Soo In; Lee, Seung-Hwan; Cheon, Eun-Jin; Kim, Hye-Geum; Lee, Heon-Jeong; Chung, In Won; Choi, Joonho; Kim, Min-Hyuk; Cho, Seong-Jin; Youn, HyunChul; Chang, Jhin-Goo; Song, Hoo Rim; Kim, Euitae; Kim, Won-Hyoung; Kim, Chul Eung; Park, Doo-Heum; Lee, Byung-Ook; Lee, Jungsun; Lee, Seung-Yup; Kang, Nuree; Jung, Hee Yeon

doi:2024.21.7.762

Psychiatry Investig > Volume 21(7); 2024 > Article

Original Article

Psychiatry Investigation 2024;21(7):762-771.
DOI: https://doi.org/10.30773/pi.2024.0052 Published online July 24, 2024.

Efficacy and Safety of Lurasidone vs. Quetiapine XR in Acutely Psychotic Patients With Schizophrenia in Korea: A Randomized, Double-Blind, Active-Controlled Trial

Se Hyun Kim^1,2

, Do-Un Jung³

, Do Hoon Kim⁴

, Jung Sik Lee⁵

, Kyoung-Uk Lee⁶

, Seunghee Won⁷

, Bong Ju Lee⁸

, Sung-Gon Kim⁹

, Sungwon Roh¹⁰

, Jong-Ik Park¹¹

, Minah Kim^1,2

, Sung Won Jung¹²

, Hong Seok Oh¹³

, Han-yong Jung¹⁴

, Sang Hoon Kim¹⁵

, Hyun Seung Chee¹⁶

, Jong-Woo Paik¹⁷

, Kyu Young Lee¹⁸

, Soo In Kim¹⁹

, Seung-Hwan Lee^20,21

, Eun-Jin Cheon²²

, Hye-Geum Kim²²

, Heon-Jeong Lee^23,24

, In Won Chung²⁵

, Joonho Choi²⁶

, Min-Hyuk Kim²⁷

, Seong-Jin Cho²⁸

, HyunChul Youn¹⁴

, Jhin-Goo Chang²⁹

, Hoo Rim Song²⁹

, Euitae Kim^2,30,31

, Won-Hyoung Kim³²

, Chul Eung Kim³³

, Doo-Heum Park^34,35

, Byung-Ook Lee³⁶

, Jungsun Lee³⁷

, Seung-Yup Lee³⁸

, Nuree Kang¹

, Hee Yeon Jung^2,39

^¹Department of Psychiatry, Seoul National University Hospital, Seoul, Republic of Korea
^²Department of Psychiatry, Seoul National University College of Medicine, Seoul, Republic of Korea
^³Department of Psychiatry, Busan Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea
^⁴Department of Psychiatry, Chuncheon Sacred Heart Hospital & Mind-Neuromodulation Laboratory, Hallym University College of Medicine, Chuncheon, Republic of Korea
^⁵Lee Jung Sik Psychiatric Clinic, Suwon, Republic of Korea
^⁶Department of Psychiatry, Uijeongbu St. Mary’s Hospital, The Catholic University of Korea College of Medicine, Uijeongbu, Republic of Korea
^⁷Department of Psychiatry, School of Medicine, Kyungpook National University, Daegu, Republic of Korea
^⁸Department of Psychiatry, Haeundae Paik Hospital, Inje University College of Medicine, Busan, Republic of Korea
^⁹Department of Psychiatry, Pusan National University Yangsan Hospital, Yangsan, Republic of Korea
^¹⁰Department of Psychiatry, Hanyang University College of Medicine, Seoul, Republic of Korea
^¹¹Department of Psychiatry, Kangwon National University School of Medicine, Chuncheon, Republic of Korea
^¹²Department of Psychiatry, Keimyung University DongSan Hospital, Daegu, Republic of Korea
^¹³Department of Psychiatry, Konyang University Hospital, Daejeon, Republic of Korea
^¹⁴Department of Psychiatry, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Republic of Korea
^¹⁵Dajeonghan Hospital, Naju, Republic of Korea
^¹⁶Department of Psychiatry, Chungnam National University Hospital, Daejeon, Republic of Korea
^¹⁷Department of Neuropsychiatry, Kyung Hee University College of Medicine, Seoul, Republic of Korea
^¹⁸Department of Psychiatry, Eulji General Hospital, Seoul, Republic of Korea
^¹⁹Department of Psychiatry, Ewha Womans University College of Medicine, Seoul, Republic of Korea
^²⁰Clinical Emotion and Cognition Research Laboratory, Goyang, Republic of Korea
^²¹Department of Psychiatry, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of Korea
^²²Department of Psychiatry, Yeungnam University Hospital, Daegu, Republic of Korea
^²³Department of Psychiatry, Korea University College of Medicine, Seoul, Republic of Korea
^²⁴Chronobiology Institute, Korea University, Seoul, Republic of Korea
^²⁵Yong-In Mental Hospital, Yongin, Korea
^²⁶Department of Psychiatry, Hanyang University Guri Hospital, Guri, Republic of Korea
^²⁷Department of Psychiatry, Wonju Severance Christian Hospital, Wonju, Republic of Korea
^²⁸Department of Psychiatry, Gil Medical Center, Gachon University College of Medicine, Incheon, Republic of Korea
^²⁹Department of Psychiatry, Myongji Hospital, Hanyang University College of Medicine, Goyang, Republic of Korea
^³⁰Department of Psychiatry, Seoul National University Bundang Hospital, Seongnam, Republic of Korea
^³¹Department of Brain & Cognitive Sciences, College of Natural Sciences, Seoul National University, Seoul, Republic of Korea
^³²Department of Psychiatry, Inha University Hospital, Incheon, Republic of Korea
^³³NCMH, Mental Health Research Institute, Seoul, Republic of Korea
^³⁴Department of Psychiatry, Konkuk University Medical Center, Seoul, Republic of Korea
^³⁵Department of Psychiatry, School of Medicine, Konkuk University, Seoul, Republic of Korea
^³⁶Department of Psychiatry, National Health Insurance Service Ilsan Hospital, Goyang, Republic of Korea
^³⁷Department of Psychiatry, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Republic of Korea
^³⁸Department of Psychiatry, Eunpyeong St. Mary’s Hospital, The Catholic University of Korea College of Medicine, Seoul, Republic of Korea
^³⁹Department of Psychiatry, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea

Correspondence: Hee Yeon Jung ,Tel: +82-2-870-2461, Fax: +82-2-870-3866, Email: hyjung@snu.ac.kr

Received: February 18, 2024 Revised: April 10, 2024 Accepted: May 13, 2024 Published online: July 24, 2024

Abstract

Objective
This study was performed to evaluate the efficacy and safety of lurasidone (160 mg/day) compared to quetiapine XR (QXR; 600 mg/day) in the treatment of acutely psychotic patients with schizophrenia.
Methods
Patients were randomly assigned to 6 weeks of double-blind treatment with lurasidone 160 mg/day (n=105) or QXR 600 mg/day (n=105). Primary efficacy measure was the change from baseline to week 6 in Positive and Negative Syndrome Scale (PANSS) total score and Clinical Global Impressions severity (CGI-S) score. Adverse events, body measurements, and laboratory parameters were assessed.
Results
Lurasidone demonstrated non-inferiority to QXR on the PANSS total score. Adjusted mean±standard error change at week 6 on the PANSS total score was -26.42±2.02 and -27.33±2.01 in the lurasidone and QXR group, respectively. The mean difference score was -0.91 (95% confidence interval -6.35–4.53). The lurasidone group showed a greater reduction in PANSS total and negative subscale on week 1 and a greater reduction in end-point CGI-S score compared to the QXR group. Body weight, body mass index, and waist circumference in the lurasidone group were reduced, with significantly lower mean change compared to QXR. Endpoint changes in glucose, cholesterol, triglycerides, and low-density lipoprotein levels were also significantly lower. The most common adverse drug reactions with lurasidone were akathisia and nausea.
Conclusion
Lurasidone 160 mg/day was found to be non-inferior to QXR 600 mg/day in the treatment of schizophrenia with comparable efficacy and tolerability. Adverse effects of lurasidone were generally tolerable, and beneficial effects on metabolic parameters can be expected.

Key words Lurasidone; Efficacy; Safety; Randomized clinical trial