Demographics and outcome measures at randomization (day 7) and at the end of 8 weeks of double-blind treatment (day 63)
| Characteristics | Group; mean (and SD) | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| All subjects (n = 55)* | Clozapine + placebo (n = 28)† | Clozapine + risperidone (n = 27)‡ | |||||||||||||
| Day | t value | df | p value | Day | t value | df | p value | Day | t value | df | p value | ||||
| 7 | 63 | 7 | 63 | 7 | 63 | ||||||||||
| Weight, kg§ | 83.62 (19.27) | 83.93 (19.16) | −0.61 | 53 | 0.55 | 81.12 (17.27) | 81.80 (16.65) | −0.94 | 26 | 0.36 | 86.11 (21.10) | 86.05 (21.48) | 0.09 | 26 | 0.93 |
| Clozapine dose, mg | 496.4 (154.0) | 492.7 (155.1) | 1.00 | 54 | 0.32 | 476.8 (148.4) | 473.2 (151.5) | 1.00 | 27 | 0.33 | 516.7 (159.8) | 513.0 (158.9) | 0.57 | 26 | 0.57 |
| PANSS | |||||||||||||||
| Total score | 98.20 (12.92) | 86.27 (16.73) | 7.07 | 54 | < 0.001 | 96.32 (11.49) | 84.11 (18.60) | 4.60 | 27 | < 0.001 | 100.15 (14.21) | 88.52 (14.54) | 5.52 | 26 | < 0.001 |
| Positive subscale score | 22.75 (5.24) | 19.71 (5.54) | 6.01 | 54 | < 0.001 | 21.36 (4.68) | 18.36 (5.56) | 4.30 | 27 | < 0.001 | 24.19 (5.48) | 21.11 (5.26) | 4.13 | 26 | < 0.001 |
| Negative subscale score | 27.60 (6.05) | 24.29 (6.35) | 5.33 | 54 | < 0.001 | 27.71 (6.53) | 24.36 (6.94) | 3.42 | 27 | 0.002 | 27.48 (5.65) | 24.22 (5.81) | 4.22 | 26 | < 0.001 |
| Serum triglycerides, mmol/L | 2.46 (1.46) | 2.40 (1.38) | 0.45 | 54 | 0.65 | 2.33 (1.12) | 2.41 (1.43) | −0.42 | 27 | 0.68 | 2.59 (1.76) | 2.39 (1.34) | 1.12 | 26 | 0.27 |
| Serum total cholesterol, mmol/L | 4.85 (1.11) | 4.81 (1.11) | 0.47 | 54 | 0.64 | 4.89 (0.99) | 4.94 (1.11) | −0.30 | 27 | 0.76 | 4.82 (1.25) | 4.67 (1.11) | 1.70 | 26 | 0.10 |
| Clozapine, ng/mL¶ | 525.1 (355.0) | 570.4 (384.4) | −1.45 | 51 | 0.15 | 497.9 (266.8) | 548.0 (349.8) | −1.14 | 26 | 0.26 | 554.5 (434.6) | 594.5 (424.6) | −0.88 | 24 | 0.39 |
| Norclozapine, ng/mL¶ | 332.2 (227.1) | 342.7 (206.3) | −0.53 | 51 | 0.60 | 316.3 (155.3) | 336.6 (203.6) | −0.99 | 26 | 0.33 | 349.4 (287.9) | 349.3 (213.2) | 0.002 | 24 | 1.00 |
SD = standard deviation; PANSS = Positive and Negative Syndrome Scale.
↵* Men: 41, women: 14; mean age 37.06 (SD 9.80) yr.
↵† Men: 21, women: 7; mean age 34.68 (SD 8.53) yr.
↵‡ Men: 20, women: 7; mean age 39.53 (SD 10.56) yr.
↵§ Weight not available for 1 subject treated with clozapine plus placebo.
↵¶ Serum concentrations not available for 1 subject treated with clozapine plus placebo and 2 subjects treated with clozapine plus risperidone.