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

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.

Keywords: Efficacy; Lurasidone; Randomized clinical trial; Safety.

Figure 1.

Flowchart describing the study flow and patient disposition. After screening, patients were randomized into either the lurasidone 160 mg/day group or the quetiapine XR 600 mg/day group. IP, Investigational product; ITT, intention-to-treat; PP, per-protocol.

Figure 2.

Change in Positive and Negative Syndrome Scale (PANSS) total score from baseline. Mixed-model repeated-measures analysis results showing the change in PANSS total score for lurasidone 160 mg/day and quetiapine XR 600 mg/day (perprotocol set). Results are shown as weekly least squares mean (LS mean)±standard error during 6 weeks of the doubleblind trial period. *p<0.05 vs. quetiapine XR. W 1–6, week 1–6.

Figure 3.

Change in Positive and Negative Syndrome Scale (PANSS) subscale scores and Clinical Global Impressions severity (CGI-S) score from baseline. Mixed-model repeated-measures analysis results showing the change in PANSS sub-scores (positive, negative, and general psychopathology) and CGI-S score for lurasidone 160 mg/day and quetiapine XR 600 mg/day (per-protocol set). Results are shown as weekly least squares mean (LS mean)±standard error during 6 weeks of the double-blind trial period. A: PANSS positive subscore. B: PANSS negative subscore. C: PANSS general psychopathology subscore. D: CGI-S score. *p<0.05 vs. quetiapine XR. W 1–6, week 1–6.