Table 3.
Mean Change from Double-Blind Baseline to Open-Label End-Point in Clinical Laboratory Analytes and HOMA-IR Values (Open-Label Safety Analysis Set)
| Laboratory analytes | Placebo/RIS group (n=30) | RIS low-dose/RIS group (n=24) | RIS high-dose/RIS group (n=25) |
|---|---|---|---|
| Glucose (mg/dL) | |||
| Mean baseline |
87.0 (9.88) |
87.2 (9.04) |
91.9 (5.15) |
| Mean change (SD) |
4.0 (12.3) |
3.5 (12.3) |
2.3 (8.8) |
| Median change (range) |
6.0 (−20; 31) |
6.0 (−27; 19) |
1.0 (−13; 15) |
| Insulin (uU/mL) | |||
| Mean baseline |
9.2 (16.28) |
5.3 (3.72) |
4.93 (2.40) |
| Mean change (SD) |
−0.11 (12.19) |
1.64 (3.93) |
3.21 (4.01) |
| Median change (range) |
2.42 (−48.2; 9.3) |
1.46 (−4.60; 10.31) |
2.13 (−1.72; 11.06) |
| Lipids (mg/dL) | |||
| Cholesterol | |||
| Mean baseline |
163.7 (24.23) |
153.4 (33.33) |
165.9 (21.36) |
| Mean change (SD) |
2.5 (25.08) |
0.3 (21.4) |
−1.6 (10.82) |
| Median change (range) |
−1.0 (−43; 60) |
−1.5 (−49; 33) |
−3.5 (−17; 21) |
| LDL | |||
| Mean baseline |
94.1 (25.61) |
85.7 (29.47) |
97.9 (21.37) |
| Mean change (SD) |
1.5 (20.55) |
0.4 (19.36) |
−0.6 (10.94) |
| Median change (range) |
−1.0 (−32; 45) |
5.0 (−59; 27) |
−1.0 (−22; 26) |
| HDL | |||
| Mean baseline |
53.9 (13.80) |
55.4 (8.62) |
54.9 (10.48) |
| Mean change (SD) |
−0.4 (7.01) |
−1.9 (9.14) |
−6.6 (10.21) |
| Median change (range) |
1.0 (−13; 13) |
−1.0 (−17; 16) |
−8.0 (−25; 13) |
| Triglycerides | |||
| Mean baseline |
78.2 (42.57) |
61.9 (20.88) |
66.1 (30.77) |
| Mean change (SD) |
7.2 (40.86) |
0.0 (22.05) |
20.3 (34.65) |
| Median change (range) |
4.0 (−66; 117) |
4.5 (−43; 46) |
11.0 (−27; 107) |
| Growth Hormones and Growth Factors | |||
| TSH (uU/mL) | |||
| Mean baseline |
1.69 (0.55) |
1.89 (0.82) |
2.16 (1.04) |
| Mean change (SD) |
0.09 (0.816) |
0.27 (0.914) |
0.05 (0.926) |
| Median change (range) |
0.0 (−1.4; 2.1) |
0.2 (−1.1; 2.4) |
0.1 (−2.3; 2.5) |
| Thyroxine (μg/dL) | |||
| Mean baseline |
8.1 (1.68) |
7.9 (1.12) |
8.7 (1.64) |
| Mean change (SD) |
0.90 (2.68) |
0.38 (0.99) |
0.06 (1.72) |
| Median change (range) |
0.4 (−2.6;10.1) |
0.3 (−1.2; 2.6) |
0.1 (−2.5; 4.1) |
| IGF-1 (ng/mL) | |||
| Mean baseline |
167.3 (79.73) |
153.9 (72.29) |
129.1(44.31) |
| Mean change (SD) |
39.2 (71.41) |
40.6 (59.80) |
53.1 (73.65) |
| Median change (range) |
28.0 (−108; 255) |
21.5 (−47; 167) |
22.0 (−29; 237) |
| IGF-1 SDS | |||
| Mean baseline |
0.10 (0.83) |
−0.65(1.26) |
−0.85(1.09) |
| Mean change (SD) |
0.41 (0.96) |
0.54 (0.98) |
0.56 (1.01) |
| Median change (range) |
0.37 (−0.98; 2.96) |
0.30 (−1.17; 2.27) |
0.47 (−1.61; 2.22) |
| IGF-BP-3 (ng/mL) | |||
| Mean baseline |
3002.4 (773.20) |
2709.1 (629.30) |
2813.2 (716.90) |
| Mean change (SD) |
−231.7 (707.34) |
−41.5 (517.87) |
−159.1 (715.06) |
| Median change (range) |
−148.0 (−1437; 933) |
−47.0 (−1028; 1422) |
−93.0 (−1257; 1400) |
| HOMA-IR | |||
| Mean baseline |
2.03 |
1.26 |
1.11 |
| Mean change (SD) | 0.09 (2.67) | 0.36 (0.89) | 0.75 (0.91) |
HDL, high density lipoprotein; LDL, low-density lipoprotein; TSH, thyroid-stimulating hormone; IGF, insulin growth factor; IGF-BP, insulin growth factor-binding protein; HOMA-IR, homeostatic model assessment of insulin resistance; RIS, Risperidone; placebo/RIS, patients randomly assigned to placebo during double-blind (DB) phase who continued into open-label extension (OLE) and received risperidone; RIS low dose/RIS, patients randomly assigned to risperidone low dose during DB phase who continued into OLE and received risperidone; RIS high dose/RIS, patients randomly assigned to risperidone high dose during DB phase who continued into OLE and received risperidone.
[HOMA-IR] formula: glucose [mmol/L]×insulin [μU/mL]/22.5 (Wallace et al. 2004).