Table 5.
Least-squares mean change from baseline to Week 24 (Visit 12) in the efficacy measures.
| Measure | Double-blind treatment phase | P valuea | ||||
|---|---|---|---|---|---|---|
| Pomaglumetad methionil (N = 511) | Aripiprazole (N = 161) | LS mean difference between pomaglumetad methionil and aripiprazole (SE) | ||||
| Baseline mean (SD) | Δ to Week 24 (Visit 12) LS mean (SE) | Baseline mean (SD) | Δ to Week 24 (Visit 12) LS mean (SE) | |||
| PANSS | ||||||
| Total score | 77.9 (24.15) | −12.03 (0.99) | 79.5 (22.19) | −15.58 (1.58) | 3.55 (1.77) | 0.045* |
| Positive | 19.1 (6.75) | −3.40 (0.32) | 19.5 (6.31) | −4.62 (0.50) | 1.21 (0.56) | 0.032* |
| Negative | 20.4 (7.13) | −2.98 (0.31) | 21.2 (7.10) | −3.34 (0.48) | 0.36 (0.54) | 0.509 |
| General psychopathology | 38.4 (13.08) | −5.80 (0.56) | 38.7 (12.10) | −7.85 (0.89) | 2.05 (1.00) | 0.040* |
| CGI-S score | 4.1 (0.79) | −0.51 (0.05) | 4.1 (0.74) | −0.69 (0.08) | 0.17 (0.09) | 0.055 |
| NSA-16 total score | 46.3 (13.34) | −6.22 (0.68) | 47.5 (13.48) | −6.37 (1.03) | 0.15 (1.11) | 0.891 |
*P < 0.05.
a P values are from type III tests of LS mean differences between treatments at each visit from MMRM.
Δ: change from baseline; LS mean: least-squares mean; N: number of patients; CGI-S: Clinical Global Impression-Severity; MMRM: mixed-effects model with repeated measures; NSA-16: 16-Item Negative Symptom Assessment; PANSS: Positive and Negative Syndrome Scale; SD: standard deviations; SE: standard error.