Table 3.
Hazard ratios comparing time to recurrence by strictest level of recovery achieved (“exclusive” analysis).
| Recurrence analysisa | ||||
|---|---|---|---|---|
| Recovery groupb | A | B | C | D |
| Patient recurrence, n/N (%) | ||||
| Total | 4/58 (6.9) | 11/79 (13.9) | 7/25 (28.0) | 53/96 (55.2) |
| Placebo | 3/24 (12.5) | 8/32 (25.0) | 3/12 (25.0) | 32/61 (52.5) |
| Venlafaxine ER | 1/34 (2.9) | 3/47 (6.4) | 4/13 (30.8) | 21/35 (60.0) |
| Between-group comparisons (placebo and venlafaxine er patients combined) | ||||
| HR vs group D | 0.020 | 0.046 | 0.134 | – |
| P value | <0.0001 | <0.0001 | <0.0001 | – |
| HR vs group C | 0.150 | 0.347 | – | – |
| P value | 0.0027 | 0.0297 | – | – |
| HR vs group B | 0.432 | – | – | – |
| P value | 0.1517 | – | – | – |
Abbreviations: ER, extended release; HAM-D17, 17-item Hamilton rating scale for depression; HR, hazard ratio.
Recurrence is defined as HAM-D17 total score >12, <50% reduction in the HAM-D17 total as compared with baseline (acute phase), Diagnostic and Statistical Manual of Mental Disorders (Fourth Edition, Text Revision) criteria met for major depression, and independent confirmation of criteria by a senior investigator.
Patient recovery group definitions:(A)HAM-D17 total score ≤3 with duration ≥120 days.(B) HAM-D17 total score ≤7 with duration ≥ 120 days, or HAM-D17 total score ≤3 with duration ≥56 days; and excluding patients from group A.(C) HAM-D17 total score ≤7 with duration ≥56 days; and excluding patients from groups A and B.(D) Patients who did not recover; ie patients not in groups A, B, or C.