Table 4

Secondary efficacy end points over the 32 weeks.

Change from Week 8 to Week 32

Characteristics

NAC

Placebo

tb

df

P



M (SE)a

M (SE)


Symptoms

YMRS

0.1 (0.4)

0.4 (0.4)

-0.68

129.7

.500

MADRS††

0.6 (1.5)

1.5 (1.5)

-0.42

141.3

.679

BDRS†

1.4 (1.4)

0.7 (1.3)

0.35

139.0

.726

CGI-BP - Severity

Depression

-0.1 (0.2)

-0.3 (0.2)

0.5

186.5

.615

Mania

0.1 (0.1)

-0.1 (0.1)

0.22

160.7

.826

Overall

0.1 (0.2)

-0.2 (0.2)

0.46

167.4

.646

CGI-BP - Improvement

Depression

0.1 (0.3)

0.2 (0.3)

-0.24

105.6

.814

Mania C

-0.2 (0.2)

0.0 (0.2)

-1.23

67.6

.222

Overall

0.1 (0.3)

0.3 (0.3)

-0.39

93.4

.695

Functioning

GAF

-3.2 (1.8)

-4.4 (1.7)

0.54

136.7

.593

SOFAS

-3.6 (1.8)

-4.5 (1.7)

0.36

165.0

.719

LIFE-RIFT

0.5 (0.5)

1.1 (0.5)

-0.76

100.5

.449

SLICE-LIFE

0.2 (0.8)

1.2 (0.8)

-0.89

107.4

.376

QLESQ

-1.7 (1.8)

-2.0 (1.7)

0.14

120.5

.890


YMRS, Young Mania Rating Scale; MADRS, Montgomery-Asberg Depression Rating Scale; BDRS, Bipolar Depression Rating Scale; CGI-BP Clinical Global Impressions - Bipolar Disorder; GAF, Global Assessment of Functioning ; SOFAS, Social and Occupational Assessment Scale; LIFE-RIFT, Range of Impaired Functioning Tool; SLICE-LIFE, Streamed Longitudinal Interval Clinical Evaluation for the Longitudinal Interview Follow-Up Evaluation; Q-LES-Q, Quality of Life Enjoyment and Satisfaction Questionnaire. aLeast squares mean (standard error) derived from MMRM; b Planned comparisons from the MMRM testing the difference in Week 8 to Week 32 change between A and B groups; c Note that the estimate here is derived without investigator in the model, will have to re-run; † Inferential statistics based on logarithmic transformed data (plus constant) because of extreme positive skewness. Untransformed descriptive statistics are reported; †† Inferential statistics based on square root transformation because of positive skewness. Untransformed descriptive statistics are reported.

Berk et al. BMC Medicine 2012 10:91   doi:10.1186/1741-7015-10-91

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