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. 2014 Jan 15;39(6):1453–1459. doi: 10.1038/npp.2013.343

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.

a

df for primary outcome measures (1, 58). df for secondary outcome measures: RBS-R (1, 56); MASC (1,55); CDI (1, 52).

b

RM-ANOVA uses last observation carried forward.