Table 4 Secondary outcomes at week 25 for step 1 randomisation
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 |