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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