Table 3.
Repeated measures analyses of continuous secondary outcomes at 2 weeks, 6 weeks, and 12 weeks
|
Sertraline |
Placebo |
Adjusted proportional difference*(95% CI) | p value | ||||
|---|---|---|---|---|---|---|---|
| n | Mean (SD) | n | Mean (SD) | ||||
| PHQ-9 | |||||||
| Follow-up assessment (weeks) | |||||||
| 2 | 277 | 9·94 (5·83) | 292 | 10·32 (5·55) | 0·96 (0·87 to 1·07) | .. | |
| 6 | 266 | 7·98 (5·63) | 284 | 8·76 (5·86) | 0·96 (0·86 to 1·07) | .. | |
| 12 | 262 | 6·90 (5·83) | 263 | 8·02 (6·12) | 0·87 (0·79 to 0·97) | .. | |
| Over time† | .. | .. | .. | .. | 0·93 (0·86 to 1·01) | 0·11 | |
| Group by time interaction | .. | .. | .. | .. | .. | 0·0905 | |
| Beck Depression Inventory, second edition | |||||||
| Follow-up assessment (weeks) | |||||||
| 2 | 273 | 18·77 (11·08) | 286 | 19·10 (11·17) | 0·99 (0·97 to 1·10) | .. | |
| 6 | 266 | 14·82 (10·44) | 285 | 15·91 (10·74) | 0·95 (0·85 to 1·07) | .. | |
| 12 | 256 | 12·44 (10·96) | 259 | 14·78 (11·70) | 0·84 (0·74 to 0·95) | .. | |
| Over time† | .. | .. | .. | .. | 0·93 (0·84 to 1·21) | 0·012 | |
| Group by time interaction | .. | .. | .. | .. | .. | 0·015 | |
| GAD-7 | |||||||
| Follow-up assessment (weeks) | |||||||
| 2 | 277 | 7·55 (5·49) | 291 | 8·16 (5·26) | 0·91 (0·82 to 1·03) | .. | |
| 6 | 264 | 5·55 (5·19) | 284 | 6·96 (5·24) | 0·79 (0·70 to 0·89) | .. | |
| 12 | 263 | 4·95 (5·30) | 263 | 6·27 (5·28) | 0·77 (0·68 to 0·87) | .. | |
| Over time† | .. | .. | .. | .. | 0·83 (0·75 to 0·91) | <0·0001 | |
| Group by time interaction | .. | .. | .. | .. | .. | 0·0075 | |
| SF-12 mental health | |||||||
| Follow-up assessment (weeks) | |||||||
| 2 | 275 | 37·32 (11·47) | 291 | 35·37 (11·36) | 1·58 (−0·10 to 3·26) | .. | |
| 6 | 254 | 41·95 (12·35) | 277 | 38·67 (11·91) | 2·90 (1·17 to 4·63) | .. | |
| 12 | 263 | 42·70 (12·91) | 264 | 39·71 (11·87) | 2·85 (1·12 to 5·47) | .. | |
| Over time† | .. | .. | .. | .. | 2·41 (1·14 to 3·69) | 0·0002 | |
| Group by time interaction | .. | .. | .. | .. | .. | 0·22 | |
| SF-12 physical health | |||||||
| Follow-up assessment (weeks) | |||||||
| 2 | 275 | 51·92 (9·18) | 291 | 52·40 (6·64) | −0·71 (−1·75 to 0·34) | .. | |
| 6 | 245 | 51·98 (8·39) | 277 | 51·76 (9·90) | −0·36 (−1·44 to 0·71) | .. | |
| 12 | 263 | 51·92 (8·53) | 264 | 52·50 (9·99) | −0·89 (−1·96 to 0·19) | .. | |
| Over time† | .. | .. | .. | .. | −0·66 (−1·48 to 0·17) | 0·12 | |
| Group by time interaction | .. | .. | .. | .. | .. | 0·79 | |
PHQ-9=Patient Health Questionnaire, 9-item version. SF-12= Short-Form Health Survey. CIS-R=Clinical Interview Schedule—Revised.
These models used a log-transformed PHQ-9 score as the outcome. Adjusted proportional differences can be interpreted as the difference in scores between randomised groups expressed as a proportion (or percentage). All multilevel models were adjusted for baseline measure of each outcome (continuous), baseline CIS-R depression severity score, and stratification variables (baseline total CIS-R score in three categories, duration of depressive episode in two categories, and site).
Calculated using data from all three follow-ups combined.