Published online Sep 19, 2026. doi: 10.5498/wjp.121038
Revised: April 16, 2026
Accepted: July 3, 2026
Published online: September 19, 2026
Processing time: 163 Days and 23.2 Hours
Early-onset schizophrenia in China represents significant clinical challenges because of limited therapeutic options and the lack of evidence-based guidelines.
To investigate the real-world use of lurasidone in Chinese children and adole
This post-hoc analysis included patients with schizophrenia receiving lurasidone monotherapy, using data from a 12-week, prospective, observational, single-arm, open-label, multi-center post-marketing surveillance in China. Patients were stratified into pediatric and adult groups. Pediatric patients were further classified by whether their final titration dose exceeded 40 mg/day. Adverse events (AEs), Brief Psychiatric Rating Scale (BPRS) and International Classification of Diseases 11th Revision (ICD-11) symptom rating scores were collected.
Of 140 pediatric patients (51 male/89 female; mean age 15.4 years), 96.4% completed the surveillance. Compared with adults, pediatric patients demonstrated slightly lower mean initial lurasidone dose (35.7 ± 10.94 mg/day vs 39.4 ± 10.70 mg/day, P < 0.001) and earlier first dose adjustment (7.1 ± 8.87 days vs 10.3 ± 13.07 days, P = 0.001). Mean daily doses for pediatric patients and adults were 65.1 ± 17.95 mg/day and 61.7 ± 21.53 mg/day, respectively (P = 0.044). During surveillance, six AEs (weight gain, n = 4; drowsiness, n = 2) occurred in six pediatric patients (4.3%). All were mild. Mean weight gain was 0.1 ± 2.21 kg. AE incidences were 4.8% and 2.8% in > 40 mg/day and ≤ 40 mg/day group, respectively (P = 1.0000). Post treatment, 37.1% of pediatric patients achieved a ≥ 50% reduction in BPRS total score, compared with 27.8% of adults. Unadjusted analyses indicated greater reductions in BPRS anxiety-depression sub-score in pediatric patients compared to adults (P < 0.001). Similar trend of reductions in ICD-11 depressive mood (P = 0.052), cognitive (P = 0.013), and positive symptoms (P = 0.001) scores was seen in pediatric patients.
Chinese pediatric patients receive lurasidone treatment at lower initial doses, undergo faster titration, and achieve slightly higher mean daily doses. Lurasidone 40-80 mg/day was well-tolerated, with low AE rates, and suggested potential improvement, particularly for patients with more severe depressive symptoms. Lurasidone appears to be a promising treatment option for Chinese children and adolescents with schizophrenia.
Core Tip: This is the first study to specifically evaluate lurasidone monotherapy in a substantial cohort of Chinese children and adolescents with schizophrenia, providing essential evidence on real-world dosing patterns, safety, and effectiveness. Pediatric patients were initiated on lurasidone at lower doses but underwent more rapid titration, ultimately reaching a slightly higher mean final and daily dose than adults. Lurasidone 40-80 mg/day was well tolerated with low rates of adverse events, suggesting potential clinical improvement, particularly in patients with more severe depressive symptoms. These findings suggest that lurasidone may be a promising treatment option for Chinese pediatric patients with schizophrenia.