Table 3.
Labs, Electrocardiogram (ECG) and pulse (Mean (SD))
| Risperidone (R) | Placebo (PL) | p-value for change, R vs. PL |
|||
|---|---|---|---|---|---|
| Baseline N=18 |
Week 7 N=15 |
Baseline N=22 |
Week 7 N=20 |
||
| Prolactin ng/ml | 15.4 (9.9) | 54.4 (36.4) | 13.7 (5.7) | 8.9 (4.7) | <0.001 |
| Glucose mg/dl | 76.1 (11.7) | 83.7 (7.2) | 83.7a (11.4) | 82.1 (5.7) | 0.08 |
| Cholesterol mg/dl | 166.7 (28.3) | 172.5 (45.0) | 169.7 (29.0) | 157.8 (34.4) | 0.08 |
| Triglycerides mg/dl | 82.8 (55.4) | 75.3 (36.8) | 69.2 (20.2) | 65.8 (24.5) | 0.73 |
| Alkaline Phosphatase (u/L) | 84.8 (48.5) | 88.7 (39.5) | 88.4 (51.9) | 95.8 (48.5) | 0.10 |
| Aspartate Aminotransferase (AST) (u/L) | 24.6 (12.5) | 22.1 (6.0) | 23.1 (9.9) | 24.7 (10.5) | 0.27 |
| Alanine Aminotransferase (ALT) (u/L) | 42.4 (15.9) | 37.9 (14.7) | 41.3 (21.1) | 41.1 (16.4) | 0.98 |
| ECG – rate | 56.1 (13.9) | 66.9 (9.6) | 57.3 (12.1) | 66.0 (15.6) | 0.43 |
| ECG -QTc | 401.4 (31.8) | 409.8 (21.3) | 399.6 (27.2) | 414.1 (23.5) | 0.20 |
| ECG -PR | 143 (21.3) | 139 (16.7) | 151.5 (20.1) | 141.4 (23.3) | 0.23 |
| Supine Pulse | 60.8 (18.8) | 69.9 (13.3) | 61.8 (13.0) | 66.6 (15.7) | 0.75 |
| Standing Pulse | 92.0 (17.9) | 91.3 (25.7) | 96.1 (21.4) | 85.1 (16.8) | 0.82 |
Note: QTc = corrected interval between start of Q and end of T wave.
a
Difference between Risperidone and Placebo for glucose at baseline was significant (p=0.04)