Clinical Study

Pomaglumetad Methionil (LY2140023 Monohydrate) and Aripiprazole in Patients with Schizophrenia: A Phase 3, Multicenter, Double-Blind Comparison

Table 5

Least-squares mean change from baseline to Week 24 (Visit 12) in the efficacy measures.

MeasureDouble-blind treatment phase valuea
Pomaglumetad methionil ( )Aripiprazole ( ) 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 score77.9 (24.15)−12.03 (0.99)79.5 (22.19)−15.58 (1.58)3.55 (1.77)0.045*
 Positive19.1 (6.75)−3.40 (0.32)19.5 (6.31)−4.62 (0.50)1.21 (0.56)0.032*
 Negative20.4 (7.13)−2.98 (0.31)21.2 (7.10)−3.34 (0.48)0.36 (0.54)0.509
 General psychopathology38.4 (13.08)−5.80 (0.56)38.7 (12.10)−7.85 (0.89)2.05 (1.00)0.040*
CGI-S score4.1 (0.79)−0.51 (0.05)4.1 (0.74)−0.69 (0.08)0.17 (0.09)0.055
NSA-16 total score46.3 (13.34)−6.22 (0.68)47.5 (13.48)−6.37 (1.03)0.15 (1.11)0.891

.
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; : 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.