Critical evaluation of paliperidone in the treatment of schizophrenia in Chinese patients: a systematic literature review

Figures & data

Figure 1 Flow diagram for study selection.

Abbreviations: ER, extended-release; RCT, randomized controlled trial.

Table 1 Efficacy of paliperidone ER in comparative studies

References	Blind	Treatment arms	Dose (mg/d)		Number of patients (enrolled)	Duration (weeks)	Mean change (% reduction versus baseline)		P-value	Response rate (%)	Remarks
			Mean	Range			BPRS	PANSS
Risperidone
Liu et al^Citation11	OL	Paliperidone ER	6.60	3–9	25	8		−38.80** (42.23)	NS	80%^A
		Risperidone	4.40	1–6	25			−36.80** (40.51)		76%^A
Li et al^Citation17	NR	Paliperidone ER		6–12	48	12		−34.7* (36.37)	<0.05
		Risperidone		2–6	62			−26.4* (27.16)
Su et al^Citation46	OL	Paliperidone ER	6.3	3–12	47	12		−41.6* (48.54)	<0.05	64%^B
		Risperidone	3.8	1–6	45			−32.8* (38.41)		60%^B
Ren et al^Citation47	NR	Paliperidone ER		3–9	76	4		−48.73* (54.53)	<0.05
		Risperidone		1–6	79			−39.15* (44.44)
Zhou et al^Citation48	NR	Paliperidone ER		3–12	38	8		−59.77** (57.38)	NS	82.9%^A
		Risperidone		2–6	38			−43.23** (41.69)		86.5%^A
Na et al^Citation20	OL	Paliperidone ER		6	40	8		−39.7** (47.26)	NS	62.5%^B
		Risperidone		1–4	40			−41.3** (48.88)		67.5%^B
Li et al^Citation49	NR	Paliperidone ER	8.32	3–12	14	6		−37.86*** (43.52)	NS
		Risperidone	5.86	1–6	20			−36.60*** (42.29)
Zhang et al^Citation50	NR	Paliperidone ER	9	3–12	47	6		−28.2** (34.60)	NS	70%^B
		Risperidone	5	2–6	47			−27.4** (33.91)		66%^B
Yuan et al^Citation51	NR	Paliperidone ER	8.9	3–12	45	6		−38.42** (41.10)	NS
		Risperidone	4.9	1–6	45			−37.46** (39.49)
Li et al^Citation52	OL	Paliperidone ER	6.67	3–9	40	8		−38.37** (44.45)	NS	67.5%^C
		Risperidone	4.32	1–6	40			−36.88** (42.90)		65%^C
Deng et al^Citation53	OL	Paliperidone ER	8.76	6–12	38	6	−28.37 (57.52)		NS	94.74%^D
		Risperidone	5.42	4–8	38		−29.73 (58.48)			92.11%^D
Liu et al^Citation54	DB	Paliperidone ER	5.8		45	8		−44.26 (54.19)	<0.05
		Risperidone	4.2		45			−41.47 (51.31)
Wang et al^Citation18	OL	Paliperidone ER		3–12	41	12		−43.3** (46.31)	<0.05
		Risperidone		1–8	40			−23.2 (25.27)
Xiong et al^Citation55		Paliperidone ER	5.49	3–9	127	8		−28.4 (42.01)	<0.05	80.3%^E	Observational study
		Risperidone		1–4	139			−24.0 (35.98)		74.8%^E
Olanzapine
Hu et al^Citation21	OL	Paliperidone ER	7.55		40	12		−20.33*** (25.57)	NS
		Olanzapine	15.87		40			−23.39*** (31.63)
Zhu et al^Citation24	NR	Paliperidone ER	10.1	3–12	15	12		−30.87* (34.62)	NS	73%^A
		Olanzapine	14.6	5–20	15			−26.25* (29.42)		67%^A
Xie et al^Citation56	OL	Paliperidone ER	6.4	3–12	40	12		−35.60** (41.21)	NS	85.7%^A
		Olanzapine	17.5	2.5–20	40			−38.59** (43.45)		87.5%^A
Ma et al^Citation57	NR	Paliperidone ER	7.6	3–12	80	8	−28.5*** (55.4)		NS	68.75%^D
		Olanzapine	17.8	10–20	76		−28.9*** (57.1)			65.78%^D
Cao et al^Citation58	NR	Paliperidone ER		3–12	30	12		−45.0** (53.9)	NS	93.3%^A
		Olanzapine		5–20	32			−50.2** (58.7)		90.6%^A
Su et al^Citation59	NR	Paliperidone ER	6.25	3–9	32	8		−38.60 (58.95)	NS	78.13%^F
		Olanzapine	10	5–10	34			−39.12 (59.04)		76.47%^F
Liang^Citation60	OL	Paliperidone ER		3–12	39	6		−57.53* (59.26)	<0.05	97.37%^A
		Olanzapine		5–20	39			−53.26* (55.16)		78.95%^A
Guo et al^Citation61	NR	Paliperidone ER		3–12	30	8		−40.8** (49.76)	<0.05
		Olanzapine		5–20	30			−31.4** (40.99)
Zhang et al^Citation22	DB	Paliperidone ER		3–12	143	6		−32.3*** (38.8)	NS	71%^G
		Olanzapine		5–15	145			−34.1*** (39.8)		69.1%^G
Aripiprazole
Zhang et al^Citation9	OL	Paliperidone ER	6.4		81	52		−32.2* (36.96)	<0.05
		Aripiprazole	14.5		90			−21.2* (23.61)
		Ziprasidone	65.3		83			−18.7* (21.25)
Xie et al^Citation62	NR	Paliperidone ER	9	3–12	34	12		−38.6** (42.97)	NS	72%^B
		Aripiprazole	15	2.5–20	34			−35.5** (40.62)		68%^B
Zhou et al^Citation63	NR	Paliperidone ER		3–12	38	8		−60.0* (57.58)	NS	86.8%^H
		Aripiprazole		5–20	40			−58.4* (56.43)		85%^H
Clozapine
Luo et al^Citation12	NR	Paliperidone ER	7.6	3–12	30	12		−49.4** (52.83)	NS
		Clozapine	278.7	200–500	30			−44.6** (48.38)
Liu et al^Citation64	OL	Paliperidone ER	6.12	3–9	25	12		−32.88** (39.01)	NS	72%^I
		Clozapine	498.00	25–600	25			−31.96** (37.56)		68%^I
Ziprasidone
Zhang et al^Citation9	OL	Paliperidone ER	6.4		81	52		−32.2* (36.96)	<0.05
		Aripiprazole	14.5		90			−21.2* (23.61)
		Ziprasidone	65.3		83			−18.7* (21.25)
He et al^Citation19	DB	Paliperidone ER	6.2	3–12	70	8		−49.24** (49.48)	<0.05	90%^A
		Ziprasidone	80.8	40–160	70			−44.13** (44.72)		74.3%^A
Placebo
Rui et al^Citation8	DB	Paliperidone ER	9.5	3–12	64	56		16.9 (32.82)	<0.0001		Patients had received 14 days of treatment before attaining baseline PANSS scores
		Placebo			71			2 (3.75)
Others
Liu et al^Citation65	NR	Paliperidone ER + magnesium valproate		6–9	23	12		−56.7* (53.69)	<0.05
				250–900
		Paliperidone ER		6–9	23			−37.3* (35.62)
Liu et al^Citation10	NR	Paliperidone ER		3–12	58	24		−51.47** (60.61)	<0.05
		Typical antipsychotics			57			−43.27** (50.79)
		Atypical antipsychotics			60			−48.62** (57.42)
Liang et al^Citation66	DB	Paliperidone ER + aripiprazole	6.0	3–12 10	20	4		−12.9 (17.74)	<0.05
		Paliperidone ER	9.6	3–12	21			−28.9 (36.44)
Yan et al^Citation13	NR	Paliperidone ER + escitalopram	6.2 15.2	3–9 10–20	42	12		−16.13* (22.13)	<0.05	85.7%^A
		Paliperidone ER	6.5	3–9	42			−12.11* (16.49)		64.3%^A
Luo et al^Citation67	NR	3 mg paliperidone ER	3	3	20	8		−23.41** (26.42)	<0.05	70%^J
		6 mg paliperidone ER	6	6	20			−30.58** (34.34)		80%^J
		9 mg paliperidone ER	9	9	20			−36.54** (41.07)		85%^J
		12 mg paliperidone ER	12	12	20			−36.82** (41.66)		85%^J
Paliperidone palmitate
Jiang et al^Citation68	OL	Paliperidone ER Paliperidone palmitate		3–12 75–150 (mg/month)	40 40	13		−8.0 (15.15) −10.2 (18.92)	NS		Patients had received 6 weeks of treatment before attaining baseline PANSS scores

Notes: Response rate definition – A: response = PANSS reduction ≥25%; B: response = (PANSS in baseline − PANSS in visit point)/(PANSS in baseline – 30)·100%$50%; C: response = relief + improvement; D: response = (BPRS in baseline – BPRS in visit point)/(BPRS in baseline – 18)·100%≥50%; E: response = PANSS reduction $20%; F: response = BPRS reduction $80%; G: response = PANSS reduction $50%; H: response = PANSS reduction $30%; I: response = (PANSS in baseline – PANSS in visit point)/(PANSS in baseline – 30)·100%≥25%; J: response = not reported.

* P<0.05;

** P<0.01;

*** P<0.001.

Abbreviations: BPRS, Brief Psychiatric Rating Scale; DB, double-blind; ER, extended-release; NR, not reported; NS, not significant; OL, open-label; PANSS, Positive and Negative Syndrome Scale.

Table 2 PANSS total score in week 1–2 in RCTs

References	Treatment arms	PANSS total score			Dose titration	Remarks
		Baseline	Week 1	Week 2
Li et al^Citation17	Paliperidone ER	95.4	88.0*,+	83.3*,+	6 mg/d was recommended; 9–12 mg/d was used when necessary
	Risperidone	97.2	92.9	88.3*	2 mg/d was recommended; 4–6 mg/d was used when necessary
Na et al^Citation20	Paliperidone ER	84.0		65.1**,+	6 mg/d
	Risperidone	84.5		79.0*	Started with 1 mg/d; increased to 4 mg/d in 1 week
Li et al^Citation49	Paliperidone ER	87.00	69.43***,+	58.78***	Started with 3 mg/d; 9–12 mg/d was used when necessary. The average dose was 8.32 mg/d
	Risperidone	86.55	81.70	60.20***	Started with 1 mg/d; 4–6 mg/d was used when necessary. The average dose was 5.86 mg/d
Zhang et al^Citation50	Paliperidone ER	81.5		64.7**,++	Started with 3 mg/d; an additional 3 mg/d was added every 1–2 weeks; final dose ranged from 3 to 12 mg/d. The average dose was 9 mg/d
	Risperidone	80.8		75.1**	Started with 2 mg/d; an additional 2 mg/d was added every 1–3 days; dose was increased to 4–6 mg/d in 2 weeks. The average dose is 5 mg/d
Yuan et al^Citation51	Paliperidone ER	93.49	80.51**,+	68.84**,+	Started with 3 mg/d; increased to 6–12 mg/d in 2 weeks according to clinical judgment. The average dose was 8.9 mg/d
	Risperidone	94.86	86.50**	75.86**	Started with 1 mg/d; increased to 3–6 mg/d in 2 weeks according to clinical judgment. The average dose was 4.9 mg/d
Li et al^Citation52	Paliperidone ER	86.32		67.02**,+	Started with 3 mg/d; increased to 6 mg/d in 1 week; a maximum of 9 mg/d was used according to clinical judgment. The average dose was 6.67 mg/d
	Risperidone	85.96		73.04**	Started with 1 mg/d; increased to 4 mg/d in 1 week; a maximum of 6 mg was used according to clinical judgment. The average dose was 4.32 mg/d
Liu et al^Citation54	Paliperidone ER	81.68		57.91***,+	Started with 6 mg/d; adjusted individual dose after 2 weeks according to clinical judgment. The average dose was 5.8 mg/d
	Risperidone	80.82		65.41***	Started with 2 mg/d; adjusted individual dose in 2 weeks according to clinical judgment. The average dose was 4.2 mg/d
Zhu et al^Citation24	Paliperidone ER	89.16	82.58+	76.79**	Started with 3 mg/d; increased to 6–12 mg/d (average 9.5) in 1 week
	Olanzapine	89.23	83.69	80.62**	Started with 5 mg/d; increased to 10–20 mg/d (average 14.6) in 1 week
Xie et al^Citation56	Paliperidone ER	88.82		68.33**,+	Started with 3 mg/d; another 3 mg/d was added every 1–2 weeks; final dose ranged from 3 to 12 mg/d according to clinical judgment. The average dose was 6.4 mg/d
	Olanzapine	86.39		76.83**	Started with 2.5 mg/d; an additional 2.5–5 mg/d was added every 5–7 days; final dose ranged from 5 to 20 mg/d according to clinical judgment. The average dose was 17.5 mg/d
Ma et al^Citation57	Paliperidone ER	51.4	43.8**,+	39.7**	Started with 3 mg/d; increased to 6–12 mg/d after 1 week. The average dose was 7.6 mg/d	BPRS
	Olanzapine	50.6	48.2	40.4**	Started with 10 mg/d; increased to 15–20 mg/d after 1 week. The average dose was 17.8 mg/d
Cao et al^Citation58	Paliperidone ER	85.4	77.1*	73.8**	Started with 3 mg/d; adjusted to 3–12 mg/d in 2 weeks according to clinical judgment
	Olanzapine	82.2	80.4	75.5*	Started with 5 mg/d; adjusted to 5–20 mg/d in 2 weeks according to clinical judgment
Su et al^Citation59	Paliperidone ER	65.48	54.80*,+	40.10*	Started with 6 mg/d; adjusted to 3–9 mg/d in 1–2 weeks according to clinical judgment. The average dose was 6.25 mg/d
	Olanzapine	66.26	61.35*	40.74*	Started with 5 mg/d; increased to 10 mg/d in 1 week
Liang et al^Citation60	Paliperidone ER	97.08	67.97*	55.29*	Started with 3 mg/d or 6 mg/d for severe cases; increased to 6 or 12 mg/d in 10 days
	Olanzapine	96.55	73.11*	58.45*	Started with 5 mg/d or 10 mg/d for severe cases; increased to 15 or 20 mg/d in 10 days
Guo et al^Citation61	Paliperidone ER	82		55.8+	Started with 6 mg/d; increased to 9 or 12 mg/d in 4–7 days. Final dose ranged from 3 to 12 mg/d according to clinical judgment
	Olanzapine	76.6		63.8	Started with 10 or 20 mg/d; adjusted to 5–20 mg/d according to clinical judgment

Notes: Versus baseline:

* P<0.05;

** P<0.01;

*** P<0.001. Versus comparison group:

+ P<0.05;

++ P<0.01.

Abbreviations: BPRS, Brief Psychiatric Rating Scale; ER, extended-release; PANSS, Positive and Negative Syndrome Scale; RCTs, randomized controlled trials.

Table 3 PSP score of paliperidone ER studies

References	Study design	Treatment arms	PSP score								Remarks
			Baseline	Week 1	Week 2	Week 4	Week 6	Week 8	Week 12	Week 24
Li et al^Citation17	RCT	Paliperidone ER	46.8		47.9	54.6*			60.3*,+
		Risperidone	47.2		48.1	52.7*			55.1*
Su et al^Citation46	RCT	Paliperidone ER	45.57					64.46*	74.32*,+
		Risperidone	44.12					63.32*	59.87*
Ren et al^Citation47	RCT	Paliperidone ER	31.77			48.72*,+
		Risperidone	32.54			37.67
Zhou et al^Citation48	RCT	Paliperidone ER	27.98					52.34+
		Risperidone	28.52					42.06
Li et al^Citation49	RCT	Paliperidone ER	56.87			69.78*	78.59*,+
		Risperidone	57.35			61.38	66.57*
Yuan et al^Citation51	RCT	Paliperidone ER	32.79	38.12**	51.67**,+	59.79**,+	65.74**,+
		Risperidone	31.55	35.24**	45.05**	53.29**	60.10**
Xie et al^Citation56	RCT	Paliperidone ER	32.75					51.58**,+	68.85**,++
		Olanzapine	31.47					45.03**	60.13**
Liang et al^Citation60	RCT	Paliperidone ER	25.00	41.79*	52.37*	68.74*,++	77.11*,++
		Olanzapine	27.06	40.26*	51.05*	62.53*	70.05*
Xie et al^Citation62	RCT	Paliperidone ER	32.75					52.68**,+	69.87**,++
		Aripiprazole	32.47					46.05**	61.24**
Zhou et al^Citation63	RCT	Paliperidone ER	45.2					78.0**,++
		Aripiprazole	46.5					55.1
Liu et al^Citation10	RCT	Paliperidone ER	50.72			66.91**			71.89**	78.87**	++ versus paliperidone ER P<0.01
		Typical antipsychotics	51.57			58.25++			52.68++	52.00++
		Atypical antipsychotics	50.51			58.32++			68.30++	70.89++
Huang et al^Citation69	Single arm	Paliperidone ER	47.07						56.61*
Shi et al^Citation14	Single arm	Paliperidone ER	54.3							73.4**
Si et al^Citation70	Single arm	Paliperidone ER	41.4			66.9		75.5**
Yang et al^Citation71	Single arm	Paliperidone ER	47.0						56.6
Wang et al^Citation72	Single arm	Paliperidone ER	52.28		64.44**	70.36**
Zhou et al^Citation73	Single arm	Paliperidone ER	39.5	52.5**	62.6**	70.5**		72.6**
Sun et al^Citation74	Single arm	Paliperidone ER	33.57						58.46**	71.32**
Wang et al^Citation23	Single arm	Paliperidone ER	51.26	61.13**	61.17**	69.43**		73.52**
Zhang et al^Citation75	Single arm	Paliperidone ER	58.6					72.4**	74.5**

Notes: Versus baseline:

* P<0.05;

** P<0.01. Versus comparison group:

+ P<0.05;

++ P<0.01.

Abbreviations: ER, extended-release; PSP, Personal and Social Performance Scale; RCT, randomized controlled trial.

Table S1 Overview of study characteristics

Study	Type	Study design	Blind	Primary sources of potential bias	Patient profile	Age overall or group means*	Sex (% male)	Outcome	Primary outcome measures	Available outcome measures
Paliperidone ER
Paliperidone ER compared with risperidone
Liu et al^Citation11	CC	RCT	OL	Observer expectation	First-episode	31.24, 32.04	54.0	Efficacy, effectiveness	PANSS	PANSS, WCST, CPT, CT, WMS-R
Li et al^Citation17	CC	RCT	NR	Blinding, noncompleters excluded		20–59		Efficacy, effectiveness, safety	PANSS	PANSS, ESRS, SF36, PSP, metabolic measures, prolactin, adverse events
Su et al^Citation46	CC	RCT	OL	Observer expectation		34.7, 35.4	48.9	Efficacy, effectiveness, safety	PANSS, PSP	PANSS, PSP, MSQ, adverse events
Ren et al^Citation47	CC	RCT	NR	Blinding		30.4, 31.2	63.2	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, adverse events
Zhou et al^Citation48	CC	RCT	NR	Blinding, noncompleters excluded	First-episode	27.6, 26.9	47.2	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, adverse events
Na et al^Citation20	CC	RCT	OL	Observer expectation		33.7, 34.5	48.8	Efficacy, safety	PANSS	PANSS, prolactin, metabolic measures, TESS
Li et al^Citation49	CC	RCT	NR	Blinding	Adolescent	16.61	41.2	Efficacy, effectiveness, safety	PANSS	PANSS, TESS, laboratory examination, PSP
Zhang et al^Citation50	CC	RCT	NR	Blinding, noncompleters excluded		32, 33	46.2	Efficacy, safety	PANSS	PANSS, TESS
Yuan et al^Citation51	CC	RCT	NR	Blinding, noncompleters excluded		33.1, 34.5	56.5	Efficacy, effectiveness	PANSS	PANSS, CGI, PSP
Li et al^Citation52	CC	RCT	OL	Observer expectation, noncompleters excluded	First-episode, male	28.6, 27.9	100.0	Efficacy, safety	PANSS, metabolic measures	PANSS, metabolic measures
Deng et al^Citation53	CC	RCT	OL	Observer expectation	First-episode, female	27.08, 26.00	0.0	Efficacy, safety	BPRS	BPRS, TESS
Liu et al^Citation54	CC	RCT	DB		First-episode	29, 30	53.3	Efficacy, safety	PANSS	PANSS, TESS, metabolic measures, prolactin
Wang et al^Citation18	CC	RCT	OL	Observer expectation		35, 37	45.7	Efficacy, effectiveness, safety	PANSS	PANSS, SDSS, TESS
Paliperidone ER compared with olanzapine
Hu et al^Citation21	Int	RCT	OL	Observer expectation, noncompleters excluded		25.24, 28.65	69.1	Efficacy, safety	PANSS, metabolic measures	PANSS, metabolic measures, adverse events, prolactin
Zhu et al^Citation24	CC	RCT	NR	Blinding	Refractory	42.7, 43.5		Efficacy, safety	PANSS	PANSS, TESS, metabolic measures
Xie et al^Citation56	CC	RCT	OL	Observer expectation, noncompleters excluded	First-episode, adolescent	13.5, 14.6	50.7	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, TESS, laboratory examination
Ma et al^Citation57	CC	RCT	NR	Blinding		38.6, 39.4	53.2	Efficacy, safety	BPRS	BPRS, TESS
Cao et al^Citation58	CC	RCT	NR	Blinding		26.00, 27.12	53.2	Efficacy, safety	PANSS	PANSS, TESS
Su et al^Citation59	CC	RCT	NR	Blinding		31.0, 32.0	51.5	Efficacy, safety	BPRS	BPRS, SAPS, TESS
Liang^Citation60	CC	RCT	OL	Observer expectation, noncompleters excluded		30.42, 29.47	53.9	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, TESS
Guo et al^Citation61	CC	RCT	NR	Blinding		35.8, 33.6	68.3	Efficacy, safety	Liver function	Liver function, PANSS, TESS
Zhang et al^Citation22	CC	RCT	DB			33, 34	54.2	Efficacy, safety	PANSS	PANSS, CGI-S, adverse events, metabolic measures, VAS, AIMS, BARS, SAS, prolactin
Paliperidone ER compared with aripiprazole
Zhang et al^Citation9	Int	RCT	OL	Observer expectation, noncompleters excluded	First-episode	27.1, 25.7, 26.3	38.9	Efficacy, safety	PANSS, metabolic measures	PANSS, CGI-S, metabolic measures
Xie et al^Citation62	CC	RCT	NR	Blinding, noncompleters excluded	First-episode, adolescent	14, 15	52.4	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, TESS
Zhou et al^Citation63	CC	RCT	NR	Blinding	Male	35.8, 35.5	100.0	Efficacy, effectiveness, safety	PANSS, sexual function	PANSS, PSP, sexual function, prolactin
Paliperidone ER compared with clozapine
Luo et al^Citation12	CC	RCT	NR	Blinding		33.4, 32.9	51.7	Efficacy, effectiveness, safety	PANSS	PANSS, TESS, WHOQOL·100, SDSS, WMS-R
Liu et al^64	CC	RCT	OL	Observer expectation	Refractory	41.46, 39.84	58.0	Efficacy, safety	PANSS	PANSS, TESS
Paliperidone ER compared with ziprasidone
Zhang et al^Citation9	Int	RCT	OL	Observer expectation, noncompleters excluded	First-episode	27.1, 25.7, 26.3	38.9	Efficacy, safety	PANSS, metabolic measures	PANSS, CGI-S, metabolic measures
He et al^Citation19	CC	RCT	DB	Noncompleters excluded		33.4, 32.8	52.9	Efficacy, effectiveness, safety	GQOLI-74	GQOLI-74, PANSS, TESS
Paliperidone ER compared with placebo
Rui et al^Citation8	Int	RCT	DB			31.1, 32.3	40.7	Effectiveness, efficacy, safety	Relapse	Relapse, PANSS, CGI-S, TEAEs
Paliperidone ER compared with others
Paliperidone ER compared with paliperidone ER + magnesium valproate
Liu et al^65	CC	RCT	NR	Blinding		36.0	76.1	Efficacy, safety	PANSS	PANSS, TESS
Paliperidone ER compared with typical antipsychotics and atypical antipsychotics
Liu et al^Citation10	CC	RCT	NR	Blinding, noncompleters excluded, concomitant antipsychotics		33.91, 33.77, 34.04	52.0	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, TESS
Paliperidone ER compared with paliperidone ER + aripiprazole
Liang et al^66	CC	RCT	DB	Noncompleters excluded		30.8, 30.3	37.5	Efficacy, safety	PANSS	PANSS, AIMS, BARNES, UKU, prolactin
Paliperidone ER compared with paliperidone ER + escitalopram
Yan et al^Citation13	CC	RCT	NR	Blinding		39.6, 38.4	51.2	Efficacy, effectiveness, safety	WAIS, WCST	PANSS, WAIS, WCST, TESS
Different dose groups of paliperidone ER
Luo et al^67	CC	RCT	NR	Blinding		18–62	52.5	Efficacy, safety	PANSS	PANSS, TESS, metabolic measures
Huang et al^69	Int	Single-arm study	OL	Observer expectation		40.3	54.6	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, social function score, adverse events
Tsai et al^76	Int	Single-arm study	NR	Blinding		NR	NR	Effectiveness	DAI-10	DAI-10, CGI-S, PSP
Shi et al^Citation14	Int	Single-arm study	OL	Observer expectation		27.6	48.9	Efficacy, effectiveness, safety	PSP, MATRICS	PSP, MATRICS, PANSS, CGI-S, SAS, BARS, adverse events
Si et al^70	Int	Single-arm study	OL	Observer expectation, noncompleters excluded	First-episode	30.0	50.0	Efficacy, effectiveness, safety	PSP	PSP, CGI-S, PANSS
Tang^77	Int	Single-arm study	OL	Observer expectation		40.1	46.1	Efficacy	PANSS	PANSS
Yang et al^71	Int	Single-arm study	OL	Observer expectation				Efficacy, effectiveness	PANSS, PSP	PANSS, PSP
Wang et al^72	CC	Single-arm study	NR	Blinding, noncompleters excluded		18–40	69.2	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, MSQ, adverse events
Li et al^78	CC	Single-arm study	NR	Blinding, concomitant antipsychotic	Adolescent	14.4	43.6	Efficacy, safety	PANSS	PANSS, TESS, laboratory examination, prolactin
Wu et al^79	CC	Single-arm study	OL	Observer expectation, noncompleters excluded		36.65	35.4	Efficacy, safety	PANSS, metabolic measures	PANSS, tolerability, metabolic measures
Zhou et al^73	CC	Single-arm study	NR	Blinding		28.7	47.2	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, metabolic measures, UKU, prolactin
Chen et al^Citation15	CC	Single-arm study	OL	Observer expectation		29.9	49.0	Effectiveness	HVLT	HVLT, BVMT-R, WAIS-III, WMS-III, Stroop, Digit Symbol-Coding, PASAT
Sun et al^74	CC	Single-arm study	NR	Blinding, noncompleters excluded	First-episode, adolescent	13.5	54.1	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, MSQ, TESS, metabolic measures
Zhang et al^Citation16	CC	Single-arm study	NR	Blinding, noncompleters excluded		35.89	45.2	Effectiveness	WCST	WCST, Stroop, TOH
Lv et al^80	CC	Single-arm study	OL	Observer expectation, noncompleters excluded		39.03	46.7	Efficacy, safety	Metabolic measures	Metabolic measures, PANSS, CGI-S, adverse events
Wang et al^Citation23	CC	Single-arm study	NR	Blinding		22.87	43.5	Efficacy, effectiveness, safety	PANSS, prolactin	PANSS, PSP, adverse events, prolactin
Zhang et al^75	CC	Single-arm study	OL	Observer expectation, noncompleters excluded		31	49.5	Efficacy, effectiveness, safety	PANSS	PANSS, CGI-S, PSP, ESRS, metabolic measures, prolactin
Liu et al^81	CC	Single-arm study	NR	Blinding		40	53.8	Efficacy	PANSS	PANSS
Xiong et al^Citation55	CC	Observational study		Noncompleters excluded		28.6, 29.2	58.7	Efficacy, safety	PANSS	PANSS, TESS
Si et al^82	Int	Pharmacokinetic study	NR	Blinding	Healthy	19–35	54.2	Pharmacokinetics, safety, tolerability	Pharmacokinetics	Pharmacokinetics
Paliperidone ER compared with paliperidone palmitate
Jiang et al^68	CC	RCT	NR	Blinding		32.7, 34.1	53.6	Efficacy, effectiveness, safety	PANSS	PANSS, TESS, PSP, MSQ
Paliperidone palmitate
Paliperidone palmitate compared with risperidone
Li et al^Citation29	Int	RCT	OL	Observer expectation		31.5, 32.0	32.8	Efficacy, effectiveness, safety	PANSS, PSP, CGI-S	PANSS, PSP, CGI-S, TEAEs
Ma et al^Citation31	CC	RCT	OL	Observer expectation, noncompleters excluded	Adolescent	16.05, 15.57	51.0	Efficacy, effectiveness, safety	PANSS	PANSS, PSP, CGI-S, adverse events
Yi et al^Citation32	CC	RCT	OL	Observer expectation, noncompleters excluded		31.5, 35.5	42.6	Efficacy, safety	PANSS	PANSS, TESS
Paliperidone palmitate compared with placebo
Wakamatsu et al^Citation30	Int	RCT	DB			45		Efficacy, safety	PANSS	PANSS, CGI-S, TEAEs
Zhang et al^Citation34	Int	Single-arm study	OL	Observer expectation	Recent-onset	28.7	65.5	Efficacy, effectiveness, safety	PANSS	PANSS, CGI-SCH, MSQ, hospitalization
Miao et al^Citation35	CC	Single-arm study	OL	Observer expectation, noncompleters excluded, concomitant antipsychotics		33.2	39.7	Efficacy, safety	PANSS	PANSS, CGI-S, TESS
Bressington et al^Citation33	Int	Retrospective observational study		Retrospective		40.86	71.2	Effectiveness	Hospitalization rate	Hospitalization rate
Si et al^Citation25	Int	Pharmacokinetic study	OL	Observer expectation		53	76.6	Pharmacokinetics, efficacy	Pharmacokinetics	Pharmacokinetics, PANSS, CGI-S
Li et al^Citation26	CC	Pharmacokinetic study	NR	Blinding, noncompleters excluded		25.44	44.4	Pharmacokinetics, efficacy, safety	Pharmacokinetics, PANSS	Pharmacokinetics, PANSS, adverse events, laboratory examination

Note:

* Where two ages appear in this column, they indicate ages for the experimental group and for the comparison group, respectively.

Abbreviations: AIMS, Abnormal Involuntary Movement Scale; BARS/BARNES, the Barnes Akathisia Rating Scale-revised; BPRS, Brief Psychiatric Rating Scale; BVMT-R, Wisconsin Brief Visuospatial Memory Tests; CC, Chinese core (journal type); CGI, Clinical Global Impression; CGI-S, Clinical Global Impression-Severity; CGI-SCH, Clinical Global Impression of Schizophrenia; CPT, Continuous Performance Task; CT, Number Cancellation Test; DAI-10, The Drug Attitude Inventory; DB, double-blind; ER, extended-release; ESRS, Extrapyramidal Syndrome Rating Scale; GQOLI-74, The Overall Quality of Life Rating Scale; HVLT, Hopkins Verbal Learning Test-Revised; Int, international (journal type); MATRICS, Measurement and Treatment Research to Improve Cognition in Schizophrenia; MSQ, Medication Satisfaction Questionnaire; NR, not reported; OL, open-label; PANSS, Positive and Negative Symptom Scale; PASAT, Paced Auditory Serial Addition Task; PSP, Personal and Social Functioning Scale; RCT, randomized controlled trial; SAPS, scale for assessment of positive symptoms; SAS, Simpson Angus Scale; SDSS, Social Disability Screening Schedule; SF36, Short Form-36; Stroop, Stroop Color and Word Test; TEAEs, treatment-emergent adverse events; TESS, Treatment-Emergent Symptom Scale; TOH, tower of Hanoi; UKU, Udvalg for Kliniske Undersogelser Side Effect Rating Scale; VAS, Visual Analog Scale; WAIS, Wechsler Adult Intelligence Scale; WAIS-III, Symbol Search Test; WCST, Wisconsin Card Sorting Test; WHOQOL, World Health Organization Quality of Life; WMS-R, Wechsler Memory Scale-Revised; WMS-III, Spatial Span subtest of Wechsler Memory Scale-III.

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