Table 2. Intent-To-Treat (n=59) Analysis Results.
Riluzole |
Placebo |
Treatment effect |
Cohen's d, 95% CI | ||||||||
---|---|---|---|---|---|---|---|---|---|---|---|
Baseline |
Week 12 |
Baseline |
Week 12 |
||||||||
EMM | SD | EMM | SD | EMM | SD | EMM | SD | Fa | P | ||
Primary outcomes (LMM) | |||||||||||
CY-BOCS total | 27.24 | 3.78 | 21.76 | 6.28 | 29.13 | 3.59 | 22.46 | 5.68 | 0.04 | 0.84 | (−0.44, 0.58) |
CY-BOCS obsessions | 13.52 | 2.20 | 10.73 | 3.60 | 14.57 | 1.98 | 11.02 | 3.27 | 0.00 | 1.00 | (−0.36, 0.66) |
CY-BOCS compulsions | 13.72 | 2.05 | 11.01 | 3.63 | 14.57 | 1.87 | 11.46 | 3.25 | 0.21 | 0.65 | (−0.53, 0.49) |
CGAS | 41.59 | 7.57 | 46.91 | 9.29 | 40.17 | 7.68 | 47.72 | 8.60 | 0.77 | 0.38 | (−0.66, 0.36) |
CGI-S | 5.59 | 0.63 | 5.04 | 0.92 | 5.63 | 0.67 | 5.03 | 0.84 | 0.001 | 0.98 | (−0.49, 0.53) |
Secondary outcomes (RM-ANOVA)b | |||||||||||
RBS-R total score | 22.14 | 15.13 | 18.24 | 15.51 | 28.03 | 15.13 | 22.93 | 15.29 | 0.35 | 0.55 | (−0.68, 0.36) |
MASC total score | 57.31 | 11.41 | 54.20 | 11.8 | 59.93 | 12.10 | 57.10 | 12.37 | 0.00 | 0.98 | (−0.47, 0.57) |
CDI total score | 50.78 | 8.86 | 49.38 | 9.03 | 51.70 | 9.17 | 49.04 | 9.26 | 0.43 | 0.52 | (−0.74, 0.34) |
Abbreviations: CGAS, Children's Global Assessment Scale; CGI-S, Clinical Global Impressions-Severity; CY-BOCS, Children's Yale-Brown Obsessive–Compulsive Scale; EMM, estimated marginal mean.
Full linear mixed model included fixed effects for time, treatment group (RIL vs PLA), and the time by treatment group interaction, as well as the baseline value of the respective outcome variable as a covariate for the primary measures. Estimated marginal means reflect group means adjusted for any covariate (baseline level of the outcome). Cohen's d reflects group differences in change scores (week 12−baseline) calculated using last observation carried forward.
df for primary outcome measures (1, 58). df for secondary outcome measures: RBS-R (1, 56); MASC (1,55); CDI (1, 52).
RM-ANOVA uses last observation carried forward.