Table 3.
Side effects and safety measures
| Omnibus test | ||||||||
|---|---|---|---|---|---|---|---|---|
| Variable | Baseline (n = 52) | Memantine 1 (n = 25) | Placebo 1 (n = 24) | After wash-out (n = 44) | Memantine 2 (n = 21) | Placebo 2 (n = 24) | χ2/F | p |
| Memantine-related AE mycosis, n (%) | χ24 = 5.750 | 0.33 | ||||||
| None | 46 (67.3) | 23 (92) | 20 (83.3) | 35 (81.4) | 12 (57.1) | 22 (88.5) | ||
| Very little | 2 (3.8) | 0 (0.0) | 3 (12.5) | 3 (7.0) | 6 (28.6) | 1 (4.2) | ||
| Little | 4 (7.7) | 2 (7.7) | 1 (4.2) | 4 (9.3) | 2 (9.5) | 1 (4.2) | ||
| Much | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (2.3) | 0 (0.0) | 0 (0.0) | ||
| Very much | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (4.8) | 0 (0.0) | ||
| Memantine-related AE dyspnea, n (%) | χ25 = 5.329 | 0.26 | ||||||
| None | 26 (50.0) | 9 (36.0) | 15 (62.5) | 19 (43.2) | 11 (52.4) | 9 (37.5) | ||
| Very little | 6 (11.5) | 10 (16.0) | 5 (20.8) | 8 (18.2) | 5 (23.8) | 4 (16.7) | ||
| Little | 13 (25.0) | 4 (40.0) | 3 (12.5) | 14 (31.8) | 4 (19.0) | 8 (33.3) | ||
| Much | 6 (11.5) | 0 (0.0) | 1 (4.2) | 0 (0.0) | 0 (0.0) | 3 (12.5) | ||
| Very much | 1 (1.9) | 2 (8.0) | 0 (0.0) | 2 (4.5) | 1 (4.8) | 0 (0.0) | ||
| Mean LUNSERS scores (s.d.)a | ||||||||
| Extrapyramidal symptoms | 13.37 (4.06) | 13.08 (4.18) | 13.33 (5.31) | 12.34 (3.94) | 13.00 (4.30) | 12.46 (3.12) | F1,182 = 1.598 | 0.21 |
| Anticholinergic side effects | 9.87 (3.46) | 9.13 (3.66) | 9.92 (3.67) | 9.26 (3.04) | 9.80 (3.86) | 8.33 (2.79) | F1,185 = 1.323 | 0.25 |
| Other autonomic side effects | 9.27 (3.16) | 8.42 (3.28) | 9.33 (3.69) | 8.95 (2.85) | 9.11 (3.04) | 8.37 (2.50) | F1,184 = 0.319 | 0.57 |
| Allergic reactions | 5.57 (1.66) | 5.17 (1.83) | 6.26 (2.49) | 6.58 (2.99) | 6.70 (3.01) | 591 (2.52) | F1,180 = 4.839 | 0.03 |
| Psychic side effects | 23.63 (6.34) | 22.36 (7.40) | 24.58 (6.90) | 22.44 (7.42) | 22.75 (7.00) | 22.08 (7.11) | F1,183 = 1.295 | 0.26 |
| Hormonal side effects | 8.20 (3.03) | 7.96 (2.22) | 8.33 (2.22) | 8.54 (2.68) | 8.72 (3.12) | 7.38 (2.27) | F1,178 = 0.066 | 0.80 |
| Miscellaneous side effects | 6.43 (1.95) | 6.54 (2.19) | 6.96 (1.76) | 6.86 (2.04) | 7.37 (1.80) | 6.83 (2.10) | F1,184 = 1.694 | 0.20 |
| Red herrings | 14.52 (4.72) | 14.83 (4.35) | 14.92 (4.49) | 15.14 (4.94) | 15.65 (5.21) | 14.78 (4.73) | F1,185 = 0.801 | 0.37 |
| Red herrings ⩾20 | 0.13 (0.35) | 0.17 (0.38) | 0.21 (4.95) | 0.21 (0.41) | 0.20 (0.41) | 0.17 (0.39) | F1,184 = 0.446 | 0.51 |
| Total | 92.80 (21.061) | 90.9 (23.95) | 95.74 (0.12) | 93.63 (23.27) | 96.00 (27.27) | 87.50 (21.94) | F1,184 = 0.041 | 0.84 |
| Total without red herring items | 78.41 (17.12) | 75.95 (20.16) | 80.70 (20.47) | 78.69 (19.37) | 80.43 (21.96) | 72.85 (17.66) | F1,161 = 0.447 | 0.73 |
| Laboratory measurement | ||||||||
| Mean clozapine plasma level, ng/ml (s.d.) | 421.27 (224.61) | 515.16 (240.43) | 376.48 (185.11) | 461.71 (219.61) | 403.06 (179.90) | 436.14 (157.07) | F1,178 = 1.387 | 0.24 |
| Range, ng/ml | 50–878 | 101–1060 | 52–671 | 60–1080 | 135–682 | 200–715 | ||
| Physical examination | ||||||||
| Mean waist circumference, cm (s.d.) | 110.04 (13.82) | 108.32 (14.71) | 104.04 (11.72) | 105.50 (13.89) | 104.41 (12.16) | 107.88 (14.86) | F1,181 = 1.205 | 0.27 |
| Mean systolic blood pressure, mmHg (s.d.) | 134.57 (18.77) | 169.00 (170.28) | 130.26 (12.59) | 130.48 (15.94) | 125.68 (12.82) | 130.75 (11.84) | F1,188 = 1.954 | 0.16 |
| Mean diastolic blood pressure, mmHg (s.d.) | 88.00 (9.77) | 86.72 (10.57) | 87.04 (8.10) | 85.95 (9.41) | 86.14 (9.70) | 83.88 (7.60) | F1,188 = 1.084 | 0.30 |
AE, Adverse event; LUNSERS, Liverpool University Neuroleptic Side-Effect Rating Scale; s.d., standard deviation.
a Extrapyramidal symptoms: items 19, 29, 34, 37, 40, 43, 48; anticholinergic side effects: items 6, 10, 32, 38, 51; other autonomic side effects: items 15, 16, 20, 27, 36; allergic reactions: items 1, 35, 47, 49; psychic side effects: items 2, 4, 9, 14, 18, 21, 23, 26, 31, 41; hormonal side effects: items 7, 13, 17, 24, 46, 50; miscellaneous side effects: items 5, 12, 39, 44; red herrings: items 3, 8, 11, 12, 25, 28, 30, 33, 42, 45.