Table 2 Secondary efficacy variables at 3 weeks in lanicemine 100 mg, lanicemine 150 mg and placebo groups (ITT, LOCF) (phase IIB study, study 9)
Efficacy variable | Lanicemine (100 mg) (n=51) | Lanicemine (150 mg) (n=51) | Placebo (n=50) |
---|---|---|---|
Response,a n (%) | 19 (37) | 15 (29) | 8 (16) |
(OR vs placebo) | OR=3.34 | OR=2.12 | |
P-value | P=0.014 | P=0.137 | |
Remission,b n (%) | 10 (20) | 11 (22) | 5 (10) |
(OR vs placebo) | OR=2.20 | OR=2.36 | |
P-value | P=0.186 | P=0.144 | |
CGI-I, n (%), category ⩽2 | 32 (65) | 24 (47) | 13 (26) |
(OR vs placebo) | OR=5.41 | OR=2.54 | |
P-value | P=<0.001 | P=0.030 | |
CGI-S score vs baseline | –1.5 | −1.5 | −0.8 |
(Δ vs placebo) | Δ=−0.7 | Δ=−0.6 | |
P value | P=0.006 | P=0.009 | |
QIDS-SR-16 score vs baseline | −8.7 | −6.8 | −6.3 |
(Δ vs placebo) | Δ=−2.5 | Δ=−0.6 | |
P-value | P=0.016 | P=0.575 | |
HAM-D-17 score vs baseline | −11.9 | −10.7 | −8.0 |
(Δ vs placebo) | Δ=−3.8 | Δ=−2.6 | |
P-value | P=0.010 | P=0.079 | |
HAM-A score vs baseline | −7.8 | −7.2 | −4.2 |
(Δ vs placebo) | Δ=−3.5 | Δ=−3.0 | |
P-value | P=0.002 | P=0.009 | |
Q-LES-Q-SF score vs baseline | 8.1 | 6.8 | 4.2 |
(Δ vs placebo) | Δ=3.9 | Δ=2.6 | |
P-value | P=0.026 | P=0.137 |