Table 7.
Change in SF-36 scores from baseline to final visit
Dose, Subgroup (n at final visit) | Physical ComponentSummary | Mental ComponentSummary | Mental HealthDomain |
---|---|---|---|
Elderly | |||
1 mg, with psychiatric disorders (n = 37)a | |||
Baseline |
40.9 (15.9) |
43.6 (9.9) |
39.5 (12.2) |
Final visit (LOCF) |
42.4 (12.2) |
50.8 (10.9) |
47.3 (11.2) |
Change from baseline |
1.5 (10.4) |
6.8 (11.2)* |
7.3 (12.0)* |
2 mg, with psychiatric disorders (n = 42) | |||
Baseline |
41.1 (15.7) |
44.7 (10.6) |
41.5 (13.2) |
Final visit (LOCF) |
43.3 (12.4) |
50.5 (9.0) |
47.0 (11.3) |
Change from baseline |
2.3 (10.6) |
5.8 (8.4)* |
5.5 (8.8)* |
1 mg, without psychiatric disorders (n = 42) | |||
Baseline |
46.8 (10.3) |
54.7 (7.2) |
53.7 (8.7) |
Final visit (LOCF) |
48.4 (7.4) |
57.5 (6.8) |
57.0 (7.2) |
Change from baseline |
1.6 (7.0) |
2.9 (7.2)† |
3.3 (8.2)† |
2 mg, without psychiatric disorders (n = 41) | |||
Baseline |
51.7 (5.0) |
55.3 (7.9) |
54.6 (7.7) |
Final visit (LOCF) |
51.5 (6.2) |
56.1 (7.4) |
55.7 (7.0) |
Change from baseline |
−0.2 (5.3) |
0.8 (7.5) |
1.1 (8.7) |
Nonelderly | |||
2 mg, with psychiatric disorders (n = 43) | |||
Baseline |
47.1 (10.4) |
38.3 (8.7) |
37.7 (9.1) |
Final visit (LOCF) |
47.5 (9.8) |
44.6 (9.7) |
43.6 (10.1) |
Change from baseline |
0.4 (10.5) |
6.3 (9.3)* |
5.9 (9.8)* |
3 mg, with psychiatric disorders (n = 36)a | |||
Baseline |
49.4 (8.8) |
39.8 (8.2) |
39.5 (6.9) |
Final visit (LOCF) |
49.5 (11.0) |
44.2 (8.3) |
44.4 (10.1) |
Change from baseline |
−0.1 (8.9) |
4.3 (9.2)‡ |
4.8 (11.3)† |
2 mg, without psychiatric disorders (n = 41) | |||
Baseline |
50.6 (8.0) |
49.8 (7.6) |
50.1 (9.1) |
Final visit (LOCF) |
51.7 (9.7) |
50.8 (9.2) |
50.7 (10.5) |
Change from baseline |
1.2 (8.6) |
1.0 (9.6) |
0.7 (12.0) |
3 mg, without psychiatric disorders (n = 39)a | |||
Baseline |
50.9 (11.4) |
49.4 (7.9) |
50.4 (7.8) |
Final visit (LOCF) |
52.5 (8.1) |
51.2 (8.1) |
51.9 (7.8) |
Change from baseline | 1.7 (10.8) | 1.7 (5.9) | 1.6 (7.3) |
All values represent mean (SD). Norm-based scorings (50 points represents the mean national standard value of Japanese people, with a standard deviation of 10).
a 1 discontinuation.
*P < 0.001, †P < 0.05, ‡P < 0.01.
LOCF = last observation carried forward; SD = standard deviation.