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Table 4 Secondary outcomes at week 25 for step 1 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

  Titrate sertraline up to 50 mg/day by week 3 Titrate sertraline up to 100 mg/day by week 3 100 mg/day vs 50 mg/day
  Least squares mean (95%CI) Least squares mean (95% CI) Adjusteda difference (95% CI)
P value
PHQ-9 6.00 (5.33 to 6.67) 5.52 (4.89 to 6.16) −0.47 (− 1.39 to 0.44)
P = 0.31
BDI-II 13.29 (12.11 to 14.46) 11.00 (9.82 to 12.19) −2.28 (− 3.91 to − 0.66)
P = 0.006
FIBSER 4.14 (3.86 to 4.42) 4.28 (4.04 to 4.51) 0.14 (−0.20 to 0.48)
P = 0.43
  Raw numbers (%) Raw numbers (%) Adjustedb OR
(95%CI)
P value
Proportion of remission 240/427 (117 of 252 who were unremitted and allocated to continue sertraline, 110 of 127 who remitted and continued on sertraline and 13 out of 48 who withdrew from protocol) 226/423 (128 of 286 who were unremitted and allocated to continue sertraline, 84 of 97 who remitted and continued on sertraline and 14 out of 40 who withdrew from protocol) 0.99 (0.66 to 1.47),
P = 0.94
  Mean (SE) Mean (SE) HR (95% CI)
P value
Time to discontinuation of allocated treatment by week 25 14.68 (0.40) 13.82 (0.37) 0.88 (0.52 to 1.48)
P = 0.63
Time to discontinuation of any treatment by week 25 17.55 (0.38) 15.55 (0.28) 1.37 (0.80 to 2.35)
P = 0.25
  Mean (SD) Mean (SD)  
Sertraline prescribed at week 25 (mg/day) 40.7 (29.1), n = 341 57.0 (45.0), n = 321  
  1. aThe linear mixed-effects repeated-measures model included fixed effects of treatment, visit (as categorical) and treatment-by-visit interaction, and random effects for subjects and sites, adjusted for age, sex, education, marital status, number of previous depressive episodes, baseline scores at weeks 0 and 1, and was weighted by inverse probability of censoring (IPCW) to account for missing outcomes due to being allocated to the combination or switching arms at step 2 randomisation
  2. bWe used weighted generalised linear mixed models with the logit link and binomial distributions to account for clustering effects for the dichotomous secondary outcomes, adjusted for age, sex, education, marital status, number of previous depressive episodes, baseline scores at weeks 0 and 1
  3. BDI-II Beck Depression Inventory 2nd edition, FIBSER Frequency, Intensity and Burden of Side Effects Rating, PHQ-9 Patient Health Questionnaire-9, SE Standard error