Psychiatry Investig.  2024 Jul;21(7):762-771. 10.30773/pi.2024.0052.

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

• Kim SH
• Jung DU
• Kim DH
• Lee JS
• Lee KU
• Won S
• Lee BJ
• Kim SG
• Roh S
• Park JI
• Kim M
• Jung SW
• Oh HS
• Jung Hy
• Kim SH
• Chee HS
• Paik JW
• Lee KY
• Kim SI
• Lee SH
• Cheon EJ
• Kim HG
• Lee HJ
• Chung IW
• Choi J
• Kim MH
• Cho SJ
• Youn H
• Chang JG
• Song HR
• Kim E
• Kim WH
• Kim CE
• Park DH
• Lee BO
• Lee J
• Lee SY
• Kang N
• Jung HY

• KMID: 2558019
• DOI: http://doi.org/10.30773/pi.2024.0052

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.

Keyword

Lurasidone; Efficacy; Safety; Randomized clinical trial