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Table 6 Secondary outcomes at week 25 for step 2 randomisation

From: Optimising first- and second-line treatment strategies for untreated major depressive disorder — the SUN☺D study: a pragmatic, multi-centre, assessor-blinded randomised controlled trial

  Continue sertraline Combine with mirtazapine Switch to mirtazapine Combine vs continue Switch vs continue Combine vs switch
  Least squares mean (95% CI) Least squares mean (95% CI) Least squares mean (95% CI) Adjusteda difference
(95% CI)
P value
Adjusteda difference
(95% CI)
P value
Adjusteda difference
(95% CI)
P value
PHQ-9 6.58 (6.09 to 7.07) 6.37 (5.88 to 6.87) 6.61 (6.12 to 7.10) −0.20 (− 0.80 to 0.40)
P = 0.51
0.03 (− 0.56 to 0.63)
P = 0.91
−0.24 (− 0.84 to 0.37)
P = 0.44
BDI-II 14.09 (13.15 to 15.03) 13.45 (12.49 to 14.41) 13.72 (12.78 to 14.67) −0.64 (− 1.88 to 0.60)
P = 0.31
−0.37 (− 1.59 to 0.86)
P = 0.56
−0.27 (− 1.51 to 0.96)
P = 0.66
FIBSER 4.34 (4.10 to 4.59) 4.46 (4.21 to 4.71) 4.48 (4.24 to 4.72) 0.12 (−0.23 to 0.47)
P = 0.51
0.14 (−0.21 to 0.48)
P = 0.44
− 0.02 (− 0.36 to 0.33)
P = 0.92
  Raw numbers (%) Raw numbers (%) Raw numbers (%) Adjustedb OR
(95% CI)
P value
Adjustedb OR
(95% CI)
P value
Adjustedb OR
(95% CI)
P value
Proportion of remission 245/538 (45.5%) 263/520 (50.3%) 262/540 (48.5%) 1.24 (0.96 to 1.49)
P = 0.10
1.16 (0.90 to 1.48),
P = 0.25
1.07 (0.80 to 1.37)
P = 0.60
  Mean (SE) Mean (SE) Mean (SE) HR (95% CI)
P value
HR (95% CI)
P value
HR (95% CI)
P value
Time to discontinuation of allocated treatment by week 25 15.97 (0.30) 15.23 (0.32) 15.56 (0.31) 1.07
(0.92 to 1.25)
P = 0.40
1.04
(0.89 to 1.21)
P = 0.64
1.03
(0.88 to 1.20)
P = 0.70
Time to discontinuation of any treatment by week 25 17.32 (0.17) 20.47 (0.23) 20.22 (0.23) 0.89
(0.69 to 1.14)
P = 0.35
1.08
(0.85 to 1.38)
P = 0.51
0.82
(0.64 to 1.05)
P = 0.11
  Mean (SD) Mean (SD) Mean (SD)    
Sertraline prescribed at week 52 (mg/day) 51.6 (38.5), n = 448 51.2 (38.3),  n = 440 10.3 (24.7), n = 457    
Mirtazapine prescribed at week 52 (mg/day) 3.9 (10.6), n = 448 12.3 (13.0), n = 440 14.6 (13.8), n = 456    
  1. aThe linear mixed-effects repeated-measures model included fixed effects of PHQ-9 at week 3, treatment, visit (as categorical), treatment-by-visit interaction, and minimisation variables for step 2 randomisation (step 1 treatment, 50% or greater reduction on PHQ-9 by week 3, moderate or greater impairment on FIBSER at week 3), and random effects for individuals and sites
  2. bWe used the logistic regression model adjusted for sites, step 1 treatment, 50% or greater reduction on PHQ-9 by week 3 and moderate or greater impairment on FIBSER at week 3
  3. BDI-II Beck Depression Inventory 2nd edition, FIBSER Frequency, Intensity and Burden of Side Effects Rating, HR hazard ratio, PHQ-9 Patient Health Questionnaire-9, SE Standard error