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Table 3 Primary and secondary outcomes at week 9 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 7.90 (7.14 to 8.66) 8.15 (7.78 to 8.52) 0.25 (−0.58 to 1.07)
P = 0.55
BDI-II 16.55 (15.43 to 17.67) 16.00 (14.88 to 17.13) −0.55 (−2.09 to 1.00)
P = 0.49
FIBSER 5.03 (4.81 to 5.26) 5.28 (4.96 to 5.61) 0.25 (− 0.15 to 0.65),
P = 0.22
  Raw numbers Raw numbers Adjustedb OR
(95% CI)
P value
Proportion of response 216/424 (111 of 251 who were unremitted and allocated to continue sertraline, 91 of 129 who remitted and continued on sertraline and 14 out of 44 who withdrew from protocol) 229/425 (122 of 286 who were unremitted and allocated to continue sertraline, 84 of 99 who remitted and continued on sertraline and 23 out of 40 who withdrew from protocol) 1.23 (0.90 to 1.67),
P = 0.19
Proportion of remission 185/424 (64 of 251 who were unremitted and allocated to continue sertraline, 110 of 129 who remitted and continued on sertraline and 11 out of 44 who withdrew from protocol) 170/426 (68 of 286 who were unremitted and allocated to continue sertraline, 86 of 99 who remitted and continued on sertraline and 16 out of 41 who withdrew from protocol) 1.09 (0.75 to 1.58),
P = 0.64
Proportion of continuation of the allocated treatment up to week 9 302/460 (204 of 261 who were unremitted and allocated to continue sertraline, 96 of 129 who remitted and continued on sertraline and 2 out of 70 who withdrew from protocol) 330/455 (248 of 290 who were unremitted and allocated to continue sertraline, 80 of 101 who remitted and continued on sertraline and 2 out of 64 who withdrew from protocol) 1.17 (0.70 to 1.98)
P = 0.53
  Mean (SD) Mean (SD)  
Sertraline prescribed at week 9 (mg/day) 45.5 (19.8), n = 384 85.3 (32.1), n = 391  
  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