Real-world safety and effectiveness of lurasidone in Chinese children and adolescents with schizophrenia: Findings from a prospective cohort

Table 1 Baseline characteristics of pediatric and adult patients receiving lurasidone monotherapy, mean ± SD/n (%)

Outcome measures	Pediatric (n = 140)	Adult (n = 1332)	P value
Male	51 (36.4)	598 (44.9)
Age, year	15.4 ± 1.66	35.3 ± 13.29	< 0.001
BMI, kg/m2	21.8 ± 3.58	23.3 ± 3.58	< 0.001
Duration of illness, year	0.8 ± 0.97	6.1 ± 8.08	< 0.0011
Number of episodes	1.4 ± 0.81	3.1 ± 3.58	< 0.0011
Number of psychosis-related hospitalizations	0.6 ± 0.84	2.3 ± 3.80	< 0.0011
Number with comorbid mental disorders		5 (0.4)
Number with family history of mental disorders	20 (14.3)	107 (8.0)	0.0122
BPRS
Total score-baseline	45.6 ± 15.67	43.9 ± 16.50
Anxiety-depression	10.8 ± 4.15	9.6 ± 4.30	0.001
Negative symptoms	8.3 ± 3.54	8.7 ± 3.72
Positive symptoms	10.8 ± 4.28	10.7 ± 4.58
Activation	6.3 ± 3.08	6.0 ± 3.14
Hostility-suspiciousness	9.3 ± 3.96	8.9 ± 3.97
ICD-11 symptom rating scale
Positive symptoms	2.3 ± 0.93	1.8 ± 0.88	0.001
Negative symptoms	1.4 ± 0.81	1.3 ± 0.75
Depressive mood symptoms	1.5 ± 0.91	1.0 ± 0.77	< 0.001
Manic mood symptoms	0.7 ± 0.85	0.7 ± 0.74
Psychomotor symptoms	1.2 ± 0.91	0.9 ± 0.80
Cognitive symptoms	1.7 ± 0.97	1.2 ± 0.79	< 0.001

¹P values calculated from Welch’s t-test.

²P values calculated from χ² test.

P values are derived from two-sample equal variance t-tests unless otherwise indicated. BMI: Body mass index; BPRS: Brief Psychiatric Rating Scale; ICD-11: International Classification of Diseases 11th Revision.

Table 2 Analysis of covariance-adjusted changes in Brief Psychiatric Rating Scale and International Classification of Diseases (11th Revision) symptom rating scores in pediatric and adult patients receiving lurasidone monotherapy through surveillance, mean ± SD/n (%)

Outcome measures	Pediatric (n = 140)	Adult (n = 1332)	Adjusted P value
BPRS
Total score-baseline	45.6 ± 15.67	43.9 ± 16.50
Reduction in total score-2/4 weeks	9 ± 8.73	9.2 ± 9.87
Reduction in total score-6/8 weeks	14.9 ± 12.28	14.5 ± 12.46
Reduction in total score-12 weeks	19.6 ± 13.72	17.3 ± 14.39
Reduction in total score-12 weeks ≥ 50%	52 (37.1)	370 (27.8)
Anxiety-depression-baseline	10.8 ± 4.15	9.6 ± 4.30	0.020
Reduction in anxiety-depression-12 weeks	4.6 ± 3.47	3.5 ± 3.33
ICD-11 symptom rating scale
Reduction in positive symptoms-12 weeks	1.5 ± 1.34	0.8 ± 1.17
Reduction in negative symptoms-12 weeks	0.6 ± 0.88	0.4 ± 0.82
Reduction in depressive mood symptoms-12 weeks	0.8 ± 1.06	0.4 ± 0.79	0.013
Reduction in manic mood symptoms-12 weeks	0.2 ± 0.45	0.2 ± 0.63	0.018
Reduction in psychomotor symptoms-12 weeks	0.3 ± 0.84	0.3 ± 0.76	< 0.001
Reduction in cognitive symptoms-12 weeks	0.8 ± 0.95	0.4 ± 0.85	0.036
Adherence
Patients completed 12 weeks-surveillance	135 (96.4)	1228 (92.2)	0.029

BPRS: Brief Psychiatric Rating Scale; ICD-11: International Classification of Diseases 11th Revision.

Table 3 Adverse events during surveillance, n (%)

Adverse events	Pediatric	Cases	Adult	Cases
Investigations	4 (2.9)	4	38 (2.9)	39
Weight gain	4 (2.9)	4	24 (1.8)	24
Prolactin elevation			10 (0.8)	10
Triglyceride elevation			2 (0.2)	2
Neurological disorders	2 (1.4)	2	9 (0.7)	10
Akathisia			5 (0.4)	5
Drowsiness	2 (1.4)	2	3 (0.2)	3
Gastrointestinal disorders			4 (0.3)	4
Nausea			4	4
Total	6 (4.3)	6	54 (4.1)	61