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Table 4 Secondary efficacy end points over the 32 weeks.

From: Maintenance N-acetyl cysteine treatment for bipolar disorder: A double-blind randomized placebo controlled trial

  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
  1. 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.