Early prediction of blonanserin response in Japanese patients with schizophrenia

Figures & data

Figure 1 The participants in the study.

Table 1 Participants’ demographics

	Total subjects	Responders: ≥20% reduction in PANSS total scores at week 8			Responders: ≥30% reduction in PANSS total scores at week 8
	N=37	Responders (n=24)	Non-responders (n=13)	P-value	Responders (n=18)	Non-responders (n=19)	P-value
Sex (males/females), n (%)	21 (56.8)/16 (43.2)	12 (50.0)/12 (50.0)	9 (69.2)/4 (30.8)	0.315	9 (50.0)/9 (50.0)	12 (63.2)/7 (36.8)	0.419
Outpatients/inpatients, n (%)	8 (21.6)/29 (78.4)	4 (16.7)/20 (83.3)	4 (30.8)/9 (69.2)	0.413	3 (16.7)/15 (83.3)	5 (26.3)/14 (73.7)	0.474
Patients with first episode/others, n (%)	21 (56.8)/16 (43.2)	15 (62.5)	6 (46.2)	0.339	10 (55.6)	11 (57.9)	0.886
Age at the recruitment years, mean (±SD)	36.5 (13.2)	35.8 (14.1)	37.6 (11.9)	0.701	37.1 (14.5)	35.8 (12.3)	0.775
PANSS score at the recruitment, mean (±SD)
PANSS total scores	111.1 (21.1)	113.6 (21.6)	106.6 (20.3)	0.345	110.3 (13.9)	111.9 (26.6)	0.826
PANSS positive subscores	28.6 (7.65)	30.1 (7.19)	25.7 (7.91)	0.0927	29.4 (6.53)	27.7 (8.68)	0.505
PANSS negative subscores	26.5 (6.69)	26.7 (6.77)	26.1 (6.80)	0.802	25.9 (4.75)	27.0 (8.22)	0.620
PANSS general subscores	56.9 (10.7)	56.9 (12.4)	57.0 (6.89)	0.982	55.4 (10.1)	58.4 (11.4)	0.414
Pharmacotherapy at the endpoint
Blonanserin dose, mg/day, mean (±SD)	13.4 (7.23)	12.3 (6.87)	15.4 (7.81)	0.227	11.1 (6.66)	15.6 (7.29)	0.0601
Antiparkinsonian drugs (biperiden), mg/day, n (%, mean (±SD))	3 (8.11, 3 (0))	0 (0.00)	3 (15.8, 3 (0))	0.0393	0 (0.00)	3 (15.8, 3 (0))	0.0393
Concomitant drugs
Lorazepam, n (%)	20 (54.1)	13 (54.2)	7 (53.9)	0.985	9 (50.0)	11 (57.9)	0.630
Lorazepam, mg/day, mean (±SD)	0.622 (0.681)	0.542 (0.509)	0.769 (0.927)	0.339	0.500 (0.514)	0.737 (0.806)	0.297
Brotizolam, n (%)	23 (62.2)	15 (62.5)	8 (61.5)	0.954	11 (61.1)	12 (63.2)	0.898
Brotizolam, mg/day, mean (±SD)	0.243 (0.209)	0.239 (0.219)	0.250 (0.194)	0.890	0.235 (0.225)	0.250 (0.198)	0.841

Abbreviations: PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.

Figure 2 The response rate.

Abbreviation: PANSS, Positive and Negative Syndrome Scale.

Table 2 Changes from baseline to week 4 and to week 8 in the PANSS total scores and PANSS subscores

	Baseline (n=37)	Mean change at week 4 (n=37)a		Mean change at week 8 (n=37)b
	Mean (±SD)	Mean change (±SD)	P-value	Mean change (±SD)	P-value
PANSS total scores	111.1 (21.1)	−25.6 (18.0)	<0.0001	−27.9 (18.2)	<0.0001
PANSS positive subscores	28.6 (7.65)	−8.38 (7.01)	<0.0001	−10.4 (7.22)	<0.0001
PANSS negative subscores	26.5 (6.69)	−5.81 (5.36)	<0.0001	−5.84 (5.93)	<0.0001
PANSS general subscores	56.9 (10.7)	−13.3 (8.03)	<0.0001	−14.4 (8.54)	<0.0001

Notes:

a Number of LOCF =0

b Number of LOCF =9 (24.3%).

Abbreviations: LOCF, last observation carried forward; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation.

Table 3 Conditional probabilities that the response at week 4 will predict the response at week 8 using thresholds for an early response of ≥10%, ≥20%, and ≥30% improvement in the PANSS total scores and thresholds for later responses of ≥20%, ≥30%, and ≥40% improvement in the PANSS total score

Improvement at week 4a	≥10% reduction in PANSS total scores			≥20% reduction in PANSS total scores		≥30% reduction in PANSS total scores
Response criteria at week 8b	≥20%	≥30%	≥40%	≥30%	≥40%	≥40%
P-value (χ^2)c	0.0019 (9.64)	0.001 (10.9)	0.0957 (2.78)	<0.0001 (18.9)	0.100 (2.70)	0.0044 (8.10)
Positive predictive value, %	76.7	60.0	20.0	80.0	25.0	41.7
Negative predictive value, %	85.7	100	100	88.9	94.1	96.0
Sensitivity, %	95.8	100	100	88.9	83.3	83.3
Specificity, %	46.2	36.8	22.6	80.0	51.6	77.4
Predictive power, %	78.4	67.6	35.1	83.8	56.8	78.4

Notes:

a Improvements at week 4 are expressed as percentage improvement over the baseline PANSS total scores.

b Response criteria at week 8 are expressed as percentage improvement over the baseline PANSS total scores.

c χ² test, df=1.

Abbreviation: PANSS, Positive and Negative Syndrome Scale.