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Table 4 Change in safety parameters from baseline to 6-month end point a

From: An open-label, multicenter evaluation of the long-term safety and efficacy of risperidone in adolescents with schizophrenia

Parameter PBO/RIS RIS/RIS Direct‐enroll All subjects
(n = 48) (n = 292) (n = 50) (N = 390)
SAS total score, mean (SD) (n = 46) (n = 180) (n = 48) (n = 274)
Baseline 0.03 (0.12) 0.11 (0.24) 0.17 (0.28) 0.11 (0.23)
Change -0.01 (0.19) -0.01 (0.28) -0.05 (0.26) -0.02 (0.27)
BARS global rating score, n (%)
Baseline (n = 47) (n = 180) (n = 48) (n = 275)
Absent or questionable 46 (98) 173 (96) 48 (100) 267 (97)
Mild to moderate akathisia 1 (2) 6 (3) 0 7 (3)
Marked to severe akathisia 0 1 (1) 0 1 (<1)
Month 6 end point (n = 47) (n = 181) (n = 50) (n = 278)
Absent or questionable 47 (100) 176 (97) 50 (100) 267 (98)
Mild to moderate akathisia 0 5 (3) 0 5 (2)
Marked to severe akathisia 0 0 0 0
AIMS, mean (SD) (n = 46) (n = 180) (n = 50) (n = 276)
Baseline 0.4 (1.3) 0.6 (1.8) 0.9 (2.2) 0.6 (1.8)
Change -0.4 (1.3) -0.2 (1.4) -0.3 (2.2) -0.3 (1.5)
Prolactin, male subjects, mean (SD), ng/mL (n = 28) (n = 159) (n = 28) (n = 215)
Baseline 18.6 (24.7) 40.4 (26.3) 55.8 (25.3) 39.6 (27.6)
Change 29.1 (32.6) 3.7 (28.5) -6.2 (22.2) 5.7 (29.8)
Prolactin, female subjects, mean (SD), ng/mL (n = 13) (n = 104) (n = 18) (n = 135)
Baseline 14.3 (6.7) 73.6 (43.0) 100.3 (62.3) 71.5 (48.5)
Change 83.4 (44.7) 11.5 (43.3) -14.0 (49.3) 15.0 (50.1)
Glucose, mean (SD), mmol/L (n = 46) (n = 267) (n = 46) (n = 359)
Baseline 5.1 (0.5) 5.1 (0.7) 5.3 (0.5) 5.2 (0.6)
Change 0.2 (0.8) 0.1 (1.5) 0.0 (0.9) 0.1 (1.4)
HDL, mean (SD), mmol/L (n = 22) (n = 215) (n = 46) (n = 283)
Baseline 1.0 (0.2) 1.3 (0.3) 1.4 (0.4) 1.3 (0.4)
Change -0.04 (0.2) -0.05 (0.2) -0.03 (0.2) -0.04 (0.2)
LDL, mean (SD), mmol/L (n = 22) (n = 214) (n = 46) (n = 282)
Baseline 2.2 (0.7) 2.4 (0.7) 2.3 (0.5) 2.4 (0.7)
Change -0.04 (0.4) 0.01 (0.6) 0.04 (0.5) 0.01 (0.5)
Total cholesterol, mean, (SD), mmol/L (n = 46) (n = 271) (n = 47) (n = 364)
Baseline 4.09 (1.07) 4.19 (0.77) 4.20 (0.71) 4.18 (0.81)
Change 0.02 (0.59) -0.04 (0.73) -0.03 (0.61) -0.04 (0.69)
Triglycerides, mean (SD), mmol/L (n = 46) (n = 271) (n = 47) (n = 364)
Baseline 1.19 (0.71) 1.13 (0.58) 1.21 (0.65) 1.15 (0.61)
Change 0.07 (0.58) -0.00 (0.64) -0.09 (0.72) -0.01 (0.64)
Leptin, mean (SD), μg/L (n = 21) (n = 217) (n = 47) (n = 285)
Baseline 11.4 (11.1) 13.1 (14.2) 12.3 (14.3) 12.9 (14.0)
Change 6.5 (12.8) 2.0 (9.3) 2.6 (7.2) 2.4 (9.3)
Height, mean (SD), cm (n = 44) (n = 278) (n = 49) (n = 371)
Baseline 163.9 (10.2) 167.3 (11.4) 173.0 (9.8) 167.6 (11.3)
Change 0.9 (1.3) 1.0 (1.6) 1.1 (1.5) 1.0 (1.6)
Weight, mean (SD), kg (n = 44) (n = 278) (n = 49) (n = 371)
Baseline 60.2 (21.3) 62.6 (13.7) 67.6 (14.3) 63.0 (14.9)
Change 4.3 (5.5) 3.9 (5.3) 4.5 (5.8) 4.0 (5.4)
BMI, mean (SD), kg/m² (n = 44) (n = 278) (n = 49) (n = 371)
Baseline 22.0 (5.9) 22.2 (3.7) 22.5 (3.9) 22.2 (4.0)
Change 1.4 (1.9) 1.1 (1.9) 1.2 (1.7) 1.2 (1.8)
  1. aIntent-to-treat population, last observation carried forward.
  2. AIMS, Abnormal Involuntary Movement Scale; BARS, Barnes Akathisia Rating Scale; BMI, body mass index; HDL, high-density lipoprotein; LDL, low-density lipoprotein; PBO, placebo; RIS, risperidone; SAS, Simpson-Angus Scale; SD, standard deviation.