Table 2.
Change in clinical symptoms from baseline to last observation in phase 1 (Intent-to-treat sample)‡
| Outcome | Olanzapine N† = 99 | Quetiapine N = 94 | Risperidone N = 84 | Placebo N = 139 | P Value (overall comparison) |
|---|---|---|---|---|---|
| NPI total score, mean change (SD) | −7.0 (18.1) | −7.3 (20.2) | −11.6 (15.4) | −4.2 (20.0) | 0.004 |
| Comparisons vs. Placebo, LS Mean Difference | −6.3 | −4.0 | −8.2 | --- | |
| [95% CI]# | [−10.8, −1.7] | [−8.7, 0.7] | [−13.0, −3.4] | ||
| P-value | P = 0.007* | P = 0.097 | P < 0.001* | ||
| CGIC, mean score (SD) | 3.9 (1.5) | 3.8 (1.5) | 3.5 (1.4) | 4.2 (1.3) | 0.005 |
| Comparisons vs. Placebo, LS Mean Difference | −0.36 | −0.43 | −0.70 | --- | |
| [95% CI]# | [−0.73, 0.01] | [−0.81, −0.04] | [−1.10, −0.30] | ||
| P-value | P = 0.057 | P = 0.031 | P < 0.001* | ||
| BPRS total score, mean change (SD) | −2.9 (11.8) | −4.2 (9.2) | −4.3 (9.2) | −2.9 (10.0) | 0.387 |
| Comparisons vs. Placebo, LS Mean Difference | −0.6 | −1.6 | −2.0 | --- | |
| [95% CI]# | [−3.0, 1.8] | [−4.1, 0.9] | [−4.5, 0.6] | ||
| P-value | P = 0.623 | P = 0.203 | P = 0.125 | ||
| BPRS Hostile Suspiciousness factor score, mean change (SD) | −0.6 (1.3) | −0.5 (1.3) | −0.7 (1.2) | −0.3 (1.2) | 0.010 |
| Comparisons vs. Placebo, LS Mean Difference | −0.4 | −0.3 | −0.5 | --- | |
| [95% CI]# | [−0.7, −0.1] | [−0.6, 0.0] | [−0.8, −0.2] | ||
| P-value | P = 0.006* | P = 0.072 | P = 0.003* | ||
| BPRS Psychosis factor score, mean change (SD) | −0.3 (1.6) | −0.4 (1.2) | −0.7 (1.3) | −0.2 (1.3) | 0.078 |
| Comparisons vs. Placebo, LS Mean Difference | −0.2 | −0.2 | −0.5 | --- | |
| [95% CI]# | [−0.5, 0.1] | [−0.5, 0.2] | [−0.8, −0.1] | ||
| P-value | P = 0.199 | P = 0.352 | P = 0.010* | ||
| BPRS Agitation factor score, mean change (SD) | −0.4 (1.2) | −0.3 (1.0) | −0.2 (1.1) | −0.1 (1.0) | 0.085 |
| Comparisons vs. Placebo, LS Mean Difference | −0.3 | −0.2 | −0.2 | --- | |
| [95% CI]# | [−0.5, 0.0] | [−0.5, 0.0] | [−0.5, 0.0] | ||
| P-value | P = 0.021 | P = 0.078 | P = 0.082 | ||
| BPRS Withdrawn Depression factor score, mean change (SD) | 0.2 (1.0) | −0.1 (0.8) | 0.1 (0.9) | −0.1 (0.8) | 0.010 |
| Comparisons vs. Placebo, LS Mean Difference | 0.3 | 0.0 | 0.2 | --- | |
| [95% CI]# | [0.1, 0.5] | [−0.2, 0.2] | [0.0, 0.4] | ||
| P-value | P = 0.003* | P = 0.987 | P = 0.088 | ||
| BPRS Cognitive Dysfunction factor score, mean change (SD) | 0.1 (0.9) | 0.0 (0.9) | −0.1 (0.9) | −0.1 (1.0) | 0.143 |
| Comparisons vs. Placebo, LS Mean Difference | 0.2 | 0.1 | 0.0 | --- | |
| [95% CI]# | [0.0, 0.4] | [−0.2, 0.3] | [−0.2, 0.2] | ||
| P-value | P = 0.036 | P = 0.603 | P = 0.932 | ||
| Cornell Depression Scale total score, mean change (SD) | −0.9 (5.8) | −0.8 (5.5) | −2.0 (5.3) | −1.2 (4.5) | 0.643 |
| Comparisons vs. Placebo, LS Mean Difference | −0.4 | −0.1 | −0.8 | --- | |
| [95% CI]# | [−1.5, 0.8] | [−1.4, 1.1] | [−2.0, 0.5] | ||
| P-value | P = 0.533 | P = 0.841 | P = 0.216 | ||
Change score <0 reflects clinical improvement on each measure in this Table. P-value and differences of Least Squares mean are based on ANCOVA model with adjustment for pooled site and baseline value. P-value (overall comparison) is for the overall 3 degree of freedom F test for treatment group; P-values in each medication group column are for medication-placebo comparisons.
Some patients discontinued prior to assessment, so the actual sample size used in the last observation analysis is lower (Olanzapine 97, Quetiapine 84, Risperidone 77, and Placebo 130). N varies slightly by score; reported N here is for CGIC. Range (min,max) per treatment is as follows: Olanzapine (94,97), Quetiapine (82,84), Risperidone (76,78), Placebo (129,130).
P-value for comparison vs. placebo is significant at 0.05 in accordance with the Hochberg adjustment for multiple comparisons.
CI denotes confidence interval.