Table 4.
Discontinuations.
| Total N |
Total discontinued (%) |
Unsatisfactory response (%) |
Adverse event (%) |
|||||
|---|---|---|---|---|---|---|---|---|
| Maintenance Aa | Venlafaxine ER | Placebo | Venlafaxine ER | Placebo | Venlafaxine ER | Placebo | Venlafaxine ER | Placebo |
| 56 days | ||||||||
| HAM-D17 ≤3 (definition 2) | 64 | 47 | 29.7 | 51.1 | 3.1 | 14.9 | 1.6 | 2.1 |
| HAM-D17 ≤7 (definition 4) | 93 | 67 | 32.3 | 49.3 | 6.5 | 14.9 | 3.2 | 1.5 |
| 120 days | ||||||||
| HAM-D17≤3 (definition 1) | 31 | 20 | 23.6 | 50.0 | 0 | 10.0 | 3.2 | 0 |
| HAM-D17 ≤7 (definition 3) | 69 | 48 | 21.7 | 41.7 | 1.4 | 10.4 | 2.9 | 2.1 |
| Maintenance Bb | Venlafaxine ER | Placebo | Venlafaxine ER | Placebo | Venlafaxine ER | Placebo | Venlafaxine ER | Placebo |
| 56 days | ||||||||
| HAM-D17 ≤3 (definition 2) | 20 | 13 | 15.0 | 23.1 | 0 | 15.4 | 5.0 | 0 |
| HAM-D17 ≤7 (definition 4) | 34 | 20 | 14.7 | 30.0 | 2.9 | 25.0 | 2.9 | 0 |
| 120 days | ||||||||
| HAM-D17 ≤3 (definition 1) | 12 | 6 | 8.3 | 0 | 0 | 0 | 0 | 0 |
| HAM-D17 ≤7 (definition 3) | 26 | 15 | 11.5 | 6.7 | 0 | 6.7 | 3.8 | 0 |
Abbreviations: ER, extended release; HAM-D17, 17-item Hamilton rating scale for depression.
Recovery definitions:(1)HAM-D17 total score ≤3 with duration ≥ 120 days.(2)HAM-D17 total score ≤3 with duration ≥56days.(3)HAM-D17 total score ≤7 with duration ≥120 days.(4) HAM-D17 total score ≤7 with duration ≥56 days.
a
Efficacy-evaluable population.
b
Intent-to-treat population.