Table 2 Change in PANSS and CGAS from baseline to 6-month end point a
PBO/RIS | RIS/RIS | Direct-enroll | All subjects | |
|---|---|---|---|---|
PANSS | (n = 46) | (n = 289) | (n = 50) | (N = 385) |
Total | ||||
Baseline, mean (SD) | 84.7 (16.8) | 72.1 (19.4) | 83.9 (13.5) | 75.1 (19.2) |
Change, mean (SD) | ‐25.7 (18.2) | ‐10.5 (17.7) | ‐19.9 (16.2) | ‐13.6 (18.4) |
p value | <-0.001 | <-0.001 | <-0.001 | <-0.001 |
Positive symptoms | ||||
Baseline, mean (SD) | 23.6 (6.0) | 19.1 (5.7) | 23.1 (4.7) | 20.1 (5.9) |
Change, mean (SD) | -8.7 (6.5) | -3.2 (5.4) | -6.2 (5.2) | -4.2 (5.8) |
p value | <-0.001 | <-0.001 | <-0.001 | <-0.001 |
Negative symptoms | ||||
Baseline, mean (SD) | 21.5 (5.4) | 19.0 (6.5) | 21.2 (4.4) | 19.6 (6.2) |
Change, mean (SD) | -5.7 (5.4) | -2.9 (5.6) | -4.6 (4.1) | -3.4 (5.5) |
p value | <-0.001 | <-0.001 | <-0.001 | <-0.001 |
Anxiety/depression | ||||
Baseline, mean (SD) | 9.7 (3.3) | 8.4 (3.1) | 10.1 (3.0) | 8.8 (3.2) |
Change, mean (SD) | -3.3 (3.2) | -1.2 (3.5) | -2.3 (3.1) | -1.6 (3.5) |
p value | < -0.001 | < -0.001 | < -0.001 | < -0.001 |
Disorganized thoughts | ||||
Baseline, mean (SD) | 19.4 (4.3) | 17.3 (5.7) | 19.8 (4.1) | 17.9 (5.4) |
Change, mean (SD) | -5.0 (4.1) | -2.4 (4.3) | -4.5 (4.3) | -3.0 (4.4) |
p value | <-0.001 | <-0.001 | <-0.001 | <-0.001 |
Uncontrolled hostility/excitement | ||||
Baseline, mean (SD) | 10.5 (3.6) | 8.4 (3.3) | 9.6 (3.1) | 8.8 (3.4) |
Change, mean (SD) | -3.1 (4.0) | -1.0 (3.5) | -2.3 (3.2) | -1.4 (3.6) |
p value | <0.001 | <0.001 | <0.001 | <0.001 |
CGAS | (n = 45) | (n = 174) | (n = 41) | (n = 260) |
Baseline, mean (SD) | 51.8 (16.7) | 55.9 (15.5) | 51.1 (15.4) | 54.4 (15.8) |
Change, mean (SD) | 16.3 (13.7) | 7.5 (14.3) | 14.4 (12.2) | 10.1 (14.3) |
p value | <-0.001 | <-0.001 | <-0.001 | <-0.001 |