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Table 5 Primary and secondary outcomes at week 9 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

9.26 (8.79 to 9.72)

8.27 (7.80 to 8.74)

8.25 (7.79 to 8.71)

−0.99 (−1.55 to − 0.43)

P = 0.0006

P = 0.0012 b

−1.01 (− 1.56 to − 0.46)

P = 0.0004

P = 0.0012 b

0.02 (− 0.54 to 0.58)

P = 0.94

P = 0.94 b

BDI-II

18.68 (17.87 to 19.49)

16.59 (15.77 to 17.40)

17.06 (16.25 to 17.86)

−2.10 (−3.12 to − 1.07)

P < 0.0001

− 1.62 (− 2.63 to − 0.61)

P = 0.0017

−0.47 (− 1.49 to 0.55)

P = 0.36

FIBSER

5.34 (5.05 to 5.63)

5.43 (5.14 to 5.72)

5.59 (5.30 to 5.88)

0.09 (−0.32 to 0.50)

P = 0.66

0.25 (−0.16 to 0.66)

P = 0.22

− 0.16 (− 0.57 to 0.25)

P = 0.44

 

Raw numbers (%)

Raw numbers (%)

Raw numbers (%)

Adjustedc OR

(95% CI)

P value

Adjustedc OR

(95% CI)

P value

Adjustedc OR

(95% CI)

P value

Proportion of response

233/537 (43.4%)

273/527 (51.8%)

275/550 (50.0%)

1.41 (1.11 to 1.85)

P = 0.0055

1.39 (1.08 to 1.78)

P = 0.0109

1.03 (0.81 to 1.33)

P = 0.79

Proportion of remission

132/537 (24.6%)

188/527 (35.7%)

174/550 (31.6%)

1.80 (1.36 to 2.38)

P < 0.0001

1.51 (1.14 to 1.99)

P = 0.0037

1.19 (0.92 to 1.55)

P = 0.19

Proportion of continuation of the allocated treatment up to week 9

452/551 (82.0%)

400/537 (74.5%)

427/558 (76.5%)

0.61 (0.45 to 0.83)

P = 0.0014

0.68 (0.50 to 0.92)

P = 0.0131

0.90 (0.67 to 1.19)

P = 0.46

 

Mean (SD)

Mean (SD)

Mean (SD)

   

Sertraline prescribed at week 9 (mg/day)

71.7 (30.0), n = 520

71.1 (29.1), n = 502

6.5 (19.0), n = 524

   

Mirtazapine prescribed at week 9 (mg/day)

0.6 (3.9), n = 520

15.1 (11.8), n = 501

18.4 (13.0), n = 524

   
  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. bHochberg method was used for adjustment of multiplicity for the primary outcome (italicised P values for PHQ-9) but not for secondary outcomes, as postulated in the statistical analysis plan [33]
  3. cWe 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
  4. BDI-II Beck Depression Inventory 2nd edition, FIBSER Frequency, Intensity and Burden of Side Effects Rating, PHQ-9 Patient Health Questionnaire-9
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BMC Medicine

ISSN: 1741-7015

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