Table 2.
Week 6 change from double-blind baseline in efficacy measures.
| LS mean (SE) | LSMD (95% CI) | Effect size | p-value | |
|---|---|---|---|---|
| PANSS total | ||||
| Lurasidone 40 mg | −22.0 (1.6) | −9.4 (−13.5, −5.2) | 0.53 | <0.001 |
| Lurasidone 80 mg | −22.7 (1.6) | −10.1 (−14.3, −5.9) | 0.57 | <0.001 |
| Lurasidone 120/160 mg | −28.7 (2.6) | −16.1 (−22.0, −10.1) | 0.90 | <0.001 |
| Placebo | −12.6 (1.5) | |||
| PANSS positive subscale | ||||
| Lurasidone 40 mg | −7.5 (0.5) | −3.7 (−5.0, −2.4) | 0.65 | <0.001 |
| Lurasidone 80 mg | −7.8 (0.5) | −4.0 (−5.3, −2.6) | 0.70 | <0.001 |
| Lurasidone 120/160 mg | −9.8 (0.9) | −5.9 (−7.9, −4.0) | 1.05 | <0.001 |
| Placebo | −3.8 (0.5) | |||
| PANSS negative subscale | ||||
| Lurasidone 40 mg | −4.7 (0.5) | −2.1 (−3.3, −0.9) | 0.42 | <0.001 |
| Lurasidone 80 mg | −4.7 (0.4) | −2.1 (−3.3, −0.9) | 0.42 | <0.001 |
| Lurasidone 120/160 mg | −5.6 (0.8) | −3.0 (−4.8, −1.3) | 0.60 | <0.001 |
| Placebo | −2.6 (0.4) | |||
| PANSS general psychopathology subscale | ||||
| Lurasidone 40 mg | −9.6 (0.8) | −3.3 (−5.4, −1.2) | 0.37 | 0.002 |
| Lurasidone 80 mg | −10.1 (0.8) | −3.8 (−5.9, −1.7) | 0.42 | <0.001 |
| Lurasidone 120/160 mg | −13.4 (1.4) | −7.1 (−10.2, −4.1) | 0.80 | <0.001 |
| Placebo | −6.3 (0.8) | |||
| CGI-S | ||||
| Lurasidone 40 mg | −1.13 (0.10) | −0.52 (−0.76, −0.27) | 0.51 | <0.001 |
| Lurasidone 80 mg | −1.10 (0.10) | −0.49 (−0.73, −0.25) | 0.48 | <0.001 |
| Lurasidone 120/160 mg | −1.60 (0.16) | −0.98 (−1.33, −0.64) | 0.96 | <0.001 |
| Placebo | −0.62 (0.09) | |||
| PANSS responders (≥30% improvement) | Responder rate (%; LOCF-endpoint) | NNT | Odds ratio (95% CI) | p-value |
| Lurasidone 40 mg | 49.3 | 6 | 2.5 (1.6, 4.1) | <0.001 |
| Lurasidone 80 mg | 51.4 | 5 | 2.7 (1.7, 4.3) | <0.001 |
| Lurasidone 120/160 mg | 55.0 | 4 | 2.2 (1.1, 4.3) | 0.025 |
| Placebo | 30.0 |
Notes: Sample size: lurasidone 40 mg (n = 151), 80 mg (n = 145), 120/160 mg (n = 60); placebo (n = 180).
Abbreviations: CGI-S, Clinical Global Impression–Severity Scale; LSMD (95% CI), LS mean difference in Week 6 change scores for lurasidone versus placebo (with 95% confidence intervals); NNT, number needed to treat; PANSS, Positive and Negative Syndrome Scale.