Table 5.
Change in PSP Scale total and subscale scores (mITT efficacy analysis set).
| Characteristic | Total (n = 294) | Achieved SR at LOCF endpoint (n = 166) | Did not achieve SR at LOCF endpoint (n = 128) |
|---|---|---|---|
| PSP total score | |||
| Baseline | 65.85 (14.03) | 70.42 (10.95) | 59.94 (15.35) |
| LOCF endpoint | 66.89 (14.28) | 72.36 (10.33) | 59.80 (15.55) |
| Mean change from baseline (95% CI) | 1.04 (–0.3, 2.3) | 1.95 (0.5, 3.4) | −0.14 (–2.5, 2.2) |
| Social useful activities | |||
| Baseline | 2.62 (1.13) | 2.28 (0.91) | 3.07 (1.22) |
| LOCF endpoint | 2.59 (1.01) | 2.19 (0.78) | 3.09 (1.06) |
| Mean change from baseline (95% CI) | −0.04 (–0.1, 0.1) | −0.08 (–0.2, 0) | 0.02 (–0.2, 0.2) |
| Personal and social relationships | |||
| Baseline | 2.63 (0.99) | 2.37 (0.88) | 2.98 (1.02) |
| LOCF endpoint | 2.59 (1.00) | 2.20 (0.81) | 3.09 (1.00) |
| Mean change from baseline (95% CI) | −0.04 (–0.1, 0.1) | −0.16 (–0.3, 0) | 0.12 (0, 0.3) |
| Self-care | |||
| Baseline | 1.79 (0.86) | 1.58 (0.74) | 2.06 (0.92) |
| LOCF endpoint | 1.79 (0.87) | 1.61 (0.76) | 2.02 (0.95) |
| Mean change from baseline (95% CI) | 0 (–0.1, 0.1) | 0.04 (–0.1, 0.2) | −0.05 (–0.2, 0.1) |
| Disturbing and aggressive behavior | |||
| Baseline | 1.14 (0.37) | 1.13 (0.35) | 1.16 (0.39) |
| LOCF endpoint | 1.11 (0.40) | 1.04 (0.23) | 1.20 (0.54) |
| Mean change from baseline (95% CI) | −0.03 (–0.1, 0) | −0.08 (–0.1, 0) | 0.05 (–0.1, 0.2) |
Values are mean (standard deviation) unless otherwise indicated. Only patients with both baseline and at least one post-baseline assessment were included in the analysis.
CI, confidence interval; LOCF, last observation carried forward; mITT, modified intent-to-treat; PSP, personal and social performance; SR, symptomatic remission.